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CompletedNCT04973449AZD2816Updated Sep 19, 2024Results posted

Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults

A Phase 2/3 interventional study of AZD1222 and AZD2816 in COVID-19 and SARS-CoV-2, sponsored by AstraZeneca. Completed at 35 sites in 4 countries. Open to participants aged 18 Years to 115 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by AstraZeneca · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
2,843
Allocation
Randomized
Ages
18 Years to 115 Years
Sex
All
01

Study summary

The aim of the study is to assess the safety, and immunogenicity of AZD2816 for the prevention of coronavirus disease 2019 (COVID-19).

Read the detailed description

The purpose of this study is to demonstrate the safety and characterize the immunogenicity of AZD2816; AstraZeneca's candidate chimpanzee adenovirus Ox1 (ChAdOx1) vector vaccine against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) variant strain B.1.351.

02

Conditions studied

  • COVID-19
  • SARS-CoV-2

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Keywords

  • COVID-19 Vaccine
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 2,843 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 115 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adult, ≥ 18 years of age at the time of consent.

    For inclusion in the SARS-CoV-2 seronegative population:

  2. No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid amplification test and no positive antibody test).
  3. Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to the nucleoprotein).
  4. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up.
  5. Able to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative) based on the assessment of the investigator.
  6. Signed informed consent obtained before conducting any study-related procedures.

  7. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    Previously COVID-19 Vaccinated Participants:

  8. Prior completion of a 2-dose primary homologous vaccination regimen against SARSCoV-2 with either AZD1222 (2 standard doses as authorized vaccine or as investigational product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA vaccine approved for emergency or conditional use. The second dose in all cases should have been administered at least 3 months prior to first administration of study intervention.

Exclusion criteria

Exclusion Criteria:

  1. History of allergy to any component of AZD1222/AZD2816.
  2. History of Guillain-Barré syndrome, any demyelinating disease, or any other neuroimmunologic condition.
  3. Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on the day prior to or day of randomization.
  4. Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).
  5. Recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention). The following exceptions are permitted: Topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days).
  6. History of primary malignancy (see protocol).
  7. History of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine.
  8. History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria.
  9. Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture.
  10. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator.
  11. Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
  12. Any autoimmune conditions, except mild psoriasis and vitiligo.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,843 participants (actual)

Study arms

  • Experimental
    Primary Vaccination Cohort:- AZD1222 (4)

    Previously unvaccinated participants received intramuscular (IM) AZD1222 5\*10\^10 viral particles (vp) on Days 1 and 29 (4-week dosing interval).

    Biological: AZD1222

  • Experimental
    Primary Vaccination Cohort:- AZD2816 (4)

    Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 29 (4-week dosing interval).

    Biological: AZD2816

  • Experimental
    Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)

    Previously unvaccinated participants received IM AZD1222 5\*10\^10 vp on Day 1 and IM AZD2816 5\*10\^10 vp on Day 29 (4-week dosing interval).

    Biological: AZD1222 · Biological: AZD2816

  • Experimental
    Primary Vaccination Cohort:- AZD2816 (12)

    Previously unvaccinated participants received IM AZD2816 5\*10\^10 vp on Days 1 and 85 (12-week dosing interval).

    Biological: AZD2816

  • Experimental
    Booster Cohort:- AZD1222:AZD1222

    Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.

    Biological: AZD1222

  • Experimental
    Booster Cohort:- AZD1222:AZD2816

    Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.

    Biological: AZD2816

  • Experimental
    Booster Cohort:- mRNA:AZD1222

    Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5\*10\^10 vp on Day 1.

    Biological: AZD1222

  • Experimental
    Booster Cohort:- mRNA:AZD2816

    Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5\*10\^10 vp on Day 1.

    Biological: AZD2816

Interventions

  • BiologicalAZD1222

    10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

  • BiologicalAZD2816

    10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.

    Time frame: During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])

  2. Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816

    The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.

    Time frame: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])

  3. Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816

    Number of participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory tests included haematology and clinical chemistry.

    Time frame: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])

  4. Geometric Mean Titre (GMT) of SARS-CoV-2 Neutralizing Antibodies (nAb) Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  5. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  6. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  7. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

Secondary outcomes

  1. Number of Participants With Local and Systemic Solicited TEAEs

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.

    Time frame: During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])

  2. Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs

    The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.

    Time frame: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])

  3. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after second dose (Day 57)

  4. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  5. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after second dose (Day 57)

  6. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  7. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after booster dose (Day 29)

  8. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  9. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after booster dose (Day 29)

  10. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  11. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  12. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after booster dose (Day 29)

  13. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  14. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after booster dose (Day 29)

  15. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  16. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  17. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after booster dose (Day 29)

  18. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  19. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after booster dose (Day 29)

  20. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  21. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  22. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after booster dose (Day 29)

  23. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  24. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after booster dose (Day 29)

  25. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  26. Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The MAAEs are defined as AEs leading to medically-attended visits that were not routine visits, or an otherwise unscheduled visit to or from medical doctor for any reason. The AESIs are events of scientific and medical interest specific to the further understanding of study drug safety profile and require close monitoring and rapid communication by the investigators to the Sponsor.

    Time frame: During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])

  27. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after second dose (Day 57)

  28. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the Original Wuhan-Hu-1 Strain.

    Time frame: 28 days after second dose (Day 57)

  29. GMT of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  30. GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  31. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after second dose (Day 57)

  32. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after second dose (Day 57)

  33. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  34. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after second dose (Day 57)

  35. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after second dose (Day 57)

  36. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  37. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  38. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  39. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  40. GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  41. GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  42. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  43. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 Variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  44. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  45. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  46. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  47. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  48. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  49. GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD2816

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  50. GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  51. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  52. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 Variant.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)

  53. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)

  54. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  55. Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after second dose (Day 57)

  56. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after first dose (Day 29)

  57. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

    Time frame: 28 days after first dose (Day 29)

  58. GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

    Time frame: 28 days after first dose (Day 29)

  59. GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29

    Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

    Time frame: 28 days after first dose (Day 29)

  60. GMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816

    Chimpanzee adenovirus Ox1 (ChAdOx1) vector nAb were measured by neutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.

    Time frame: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)

  61. Percentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816

    Chimpanzee adenovirus Ox1 vector nAb were measured by neutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline.

    Time frame: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)

  62. GMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts

    Severe acute respiratory syndrome-coronavirus-2 spike protein binding antibodies were measured by multiplexed immunoassay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.

    Time frame: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)

  63. Percentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts

    Severe acute respiratory syndrome-coronavirus-2 spike protein binding antibodies were measured by multiplexed immunoassay. Seroresponse was defined as \>= 4-fold increase in the GMT of spike protein binding antibodies from baseline.

    Time frame: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)

  64. Correlation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres

    Severe acute respiratory syndrome-coronavirus-2 nAb and ChAdOx1 vector nAb were measured by pseudoneutralisation assay. Correlations were based on log2 titre values and assessed by using Spearman rank correlation for all cohorts except Primary Vaccination Cohort:- AZD2816 (12) for which Pearson correlation was used. The correlation coefficient is reported in values from +1 to -1 (+1= perfect association, 0 = no association, and -1= perfect negative association). The closer the correlation coefficient is to zero, weaker the association.

    Time frame: Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)

07

Results

Posted Sep 19, 2024
Limitations and caveats
Since different assays were used between strains and also within the same strains between this study and historical control study D8110C00001 (NCT04516746), spike protein binding antibody results were summarised descriptively; no comparative analyses were conducted.

Participant flow

Participant flow — Overall Study
MilestonePrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
Started409413411208373377322321
Completed389393391189359366303308
Not completed2020201914111913
Withdrew: Withdrawal by subject33255475
Withdrew: Lost to follow-up1516161356106
Withdrew: Death10000100
Withdrew: Other11214022

Outcome measures

PrimaryNumber of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.

Time frame:
During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
Reported as:
Count of participants · Participants
Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816
ParticipantsPrimary Vaccination Cohort:- AZD2816 (4)Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD2816
Any solicited AEs319275277
Any local solicited AEs278225236
Any systemic solicited AEs289211253
PrimaryNumber of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816

The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.

Time frame:
During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816
ParticipantsPrimary Vaccination Cohort:- AZD2816 (4)Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD2816
Any unsolicited TEAEs967079
Any TESAEs101
Any MAAEs312624
Any AESIs1016
PrimaryNumber of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816

Number of participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory tests included haematology and clinical chemistry.

Time frame:
During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
ParticipantsPrimary Vaccination Cohort:- AZD2816 (4)Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD2816
Anaemia100
Eosinophilia101
Iron deficiency anaemia201
Hypercholesterolaemia100
Alanine aminotransferase increased100
Fibrin D dimer increased124
Haematocrit decreased100
Haemoglobin decreased200
Transaminases increased100
Lymphopenia010
Normochromic normocytic anaemia010
Thrombocytopenia010
Hyponatraemia010
Blood creatine increased010
White blood cell count increased020
Aspartate aminotransferase increased001
Blood alkaline phosphatase increased001
Blood fibrinogen increased002
Vitamin D decreased001
PrimaryGeometric Mean Titre (GMT) of SARS-CoV-2 Neutralizing Antibodies (nAb) Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
Geometric Mean Titre (GMT) of SARS-CoV-2 Neutralizing Antibodies (nAb) Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Geometric Mean Titre (GMT) of SARS-CoV-2 Neutralizing Antibodies (nAb) Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)790.96 (735.29 to 850.85)661.29 (617.16 to 708.57)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 1.19 · 95% CI 1.08 to 1.32
PrimaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control
1/dilutionBooster Cohort:- AZD1222:AZD1222Historical Control
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control246.45 (227.39 to 267.12)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 vs Historical Control · Gmt ratio: 1.02 · 95% CI 0.90 to 1.14
PrimaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)89.47 (85.73 to 92.52)87.79 (83.86 to 91.06)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: 1.68 · 95% CI -3.11 to 6.49
PrimaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control
1/dilutionBooster Cohort:- mRNA:AZD1222Historical Control
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control841.96 (790.34 to 896.96)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 vs Historical Control · Gmt ratio: 3.47 · 95% CI 3.09 to 3.89
SecondaryNumber of Participants With Local and Systemic Solicited TEAEs

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.

Time frame:
During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Reported as:
Count of participants · Participants
Number of Participants With Local and Systemic Solicited TEAEs
ParticipantsPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- mRNA:AZD1222
Any solicited AEs322168266269
Any local solicited AEs285146209228
Any systemic solicited AEs296153206238
SecondaryNumber of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs

The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.

Time frame:
During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs
ParticipantsPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- mRNA:AZD1222
Any unsolicited TEAEs93678173
Any TESAEs2000
Any MAAEs37253416
Any AESIs9736
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)865.48 (837.85 to 894.02)269.89 (260.72 to 279.37)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 3.21 · 95% CI 3.06 to 3.36
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)405.20 (373.64 to 439.43)800.92 (745.59 to 860.36)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.50 · 95% CI 0.45 to 0.56
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)222.75 (201.60 to 246.12)719.37 (654.68 to 790.46)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.31 · 95% CI 0.27 to 0.35
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
1/dilutionBooster Cohort:- AZD1222:AZD2816Historical Control
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control341.96 (315.48 to 370.66)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Historical Control · Gmt ratio: 1.41 · 95% CI 1.25 to 1.58
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
1/dilutionBooster Cohort:- AZD1222:AZD2816Booster Cohort:- AZD1222:AZD1222
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222341.96 (315.48 to 370.66)185.70 (169.32 to 203.66)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Booster Cohort:- AZD1222:AZD1222 · Gmt ratio: 1.84 · 95% CI 1.63 to 2.08
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control
1/dilutionBooster Cohort:- AZD1222:AZD2816Historical Control
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control213.26 (197.45 to 230.34)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Historical Control · Gmt ratio: 0.88 · 95% CI 0.78 to 0.99
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
1/dilutionBooster Cohort:- AZD1222:AZD2816Booster Cohort:- AZD1222:AZD1222
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222213.26 (197.45 to 230.34)246.45 (227.39 to 267.12)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Booster Cohort:- AZD1222:AZD1222 · Gmt ratio: 0.87 · 95% CI 0.78 to 0.97
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionBooster Cohort:- AZD1222:AZD2816Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)341.96 (315.48 to 370.66)360.43 (324.90 to 399.84)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.95 · 95% CI 0.83 to 1.08
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
1/dilutionBooster Cohort:- mRNA:AZD2816Historical Control
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control1587.58 (1463.98 to 1721.61)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Historical Control · Gmt ratio: 6.56 · 95% CI 5.82 to 7.40
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
1/dilutionBooster Cohort:- mRNA:AZD2816Booster Cohort:- mRNA:AZD1222
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD12221587.58 (1463.98 to 1721.61)718.90 (670.46 to 770.84)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Booster Cohort:- mRNA:AZD1222 · Gmt ratio: 2.22 · 95% CI 1.99 to 2.47
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control
1/dilutionBooster Cohort:- mRNA:AZD2816Historical Control
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control1052.73 (974.55 to 1137.19)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Historical Control · Gmt ratio: 4.35 · 95% CI 3.86 to 4.90
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
1/dilutionBooster Cohort:- mRNA:AZD2816Booster Cohort:- mRNA:AZD1222
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD12221052.73 (974.55 to 1137.19)841.96 (790.34 to 896.96)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Booster Cohort:- mRNA:AZD1222 · Gmt ratio: 1.25 · 95% CI 1.13 to 1.39
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionBooster Cohort:- mRNA:AZD2816Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)1587.58 (1463.98 to 1721.61)360.43 (324.90 to 399.84)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 4.42 · 95% CI 3.85 to 5.08
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- AZD1222:AZD2816Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control82.81 (78.22 to 86.78)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Historical Control · Seroresponse difference: -1.24 · 95% CI -6.62 to 3.84
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
Percentage of participantsBooster Cohort:- AZD1222:AZD2816Booster Cohort:- AZD1222:AZD1222
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD122282.81 (78.22 to 86.78)65.96 (60.56 to 71.07)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Booster Cohort:- AZD1222:AZD1222 · Seroresponse difference: 16.86 · 95% CI 10.18 to 23.32
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- AZD1222:AZD2816Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control65.94 (60.46 to 71.12)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Historical Control · Seroresponse difference: -18.12 · 95% CI -24.22 to -12.07
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Booster Cohort:- AZD1222:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222
Percentage of participantsBooster Cohort:- AZD1222:AZD2816Booster Cohort:- AZD1222:AZD1222
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD122265.94 (60.46 to 71.12)65.96 (60.56 to 71.07)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Booster Cohort:- AZD1222:AZD1222 · Seroresponse difference: -0.02 · 95% CI -7.28 to 7.23
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsBooster Cohort:- AZD1222:AZD2816Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)82.81 (78.22 to 86.78)51.45 (46.03 to 56.85)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: 31.36 · 95% CI 24.44 to 37.82
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- mRNA:AZD2816Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control80.51 (75.34 to 85.00)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Historical Control · Seroresponse difference: -3.55 · 95% CI -9.40 to 1.90
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
Percentage of participantsBooster Cohort:- mRNA:AZD2816Booster Cohort:- mRNA:AZD1222
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD122280.51 (75.34 to 85.00)57.50 (51.48 to 63.36)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Booster Cohort:- mRNA:AZD1222 · Seroresponse difference: 23.01 · 95% CI 15.41 to 30.23
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- mRNA:AZD2816Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control49.82 (43.78 to 55.86)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Historical Control · Seroresponse difference: -34.24 · 95% CI -40.77 to -27.45
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Booster Cohort:- mRNA:AZD1222 is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after booster dose (Day 29)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222
Percentage of participantsBooster Cohort:- mRNA:AZD2816Booster Cohort:- mRNA:AZD1222
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD122249.82 (43.78 to 55.86)42.86 (36.99 to 48.88)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Booster Cohort:- mRNA:AZD1222 · Seroresponse difference: 6.96 · 95% CI -1.31 to 15.10
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsBooster Cohort:- mRNA:AZD2816Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)80.51 (75.34 to 85.00)51.45 (46.03 to 56.85)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: 29.05 · 95% CI 21.76 to 35.81
SecondaryNumber of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The MAAEs are defined as AEs leading to medically-attended visits that were not routine visits, or an otherwise unscheduled visit to or from medical doctor for any reason. The AESIs are events of scientific and medical interest specific to the further understanding of study drug safety profile and require close monitoring and rapid communication by the investigators to the Sponsor.

Time frame:
During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts])
Reported as:
Count of participants · Participants
Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose
ParticipantsPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
Any TESAEs2526734
Any MAAEs69825072654758
Any AESIs48513241423133
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)446.63 (432.91 to 460.78)329.46 (319.47 to 339.76)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 1.36 · 95% CI 1.30 to 1.42
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the Original Wuhan-Hu-1 Strain.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)581.78 (553.12 to 611.92)769.03 (731.95 to 808.00)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.76 · 95% CI 0.70 to 0.81
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4) (Comparator)Primary Vaccination Cohort:- AZD2816 (4) (Reference)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)718.10 (662.58 to 778.27)185.70 (168.16 to 205.07)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) (Comparator) vs Primary Vaccination Cohort:- AZD2816 (4) (Reference) · Gmt ratio: 3.87 · 95% CI 3.40 to 4.39
SecondaryGMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
1/dilutionPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Comparator)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Reference)
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)392.13 (380.34 to 404.28)586.00 (566.15 to 606.54)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Comparator) vs Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Reference) · Gmt ratio: 0.67 · 95% CI 0.64 to 0.70
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)100 (98.73 to NA)99.42 (97.92 to 99.93)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: 0.58 · 95% CI -0.61 to 2.09
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)49.42 (44.00 to 54.85)84.59 (80.34 to 88.24)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: -35.18 · 95% CI -41.46 to -28.44
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)62.57 (57.14 to 67.78)87.50 (83.53 to 90.80)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: -24.93 · 95% CI -31.06 to -18.56
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)99.40 (97.85 to 99.93)99.42 (97.92 to 99.93)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: -0.02 · 95% CI -1.63 to 1.56
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)80.24 (75.56 to 84.38)99.42 (97.92 to 99.93)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: -19.18 · 95% CI -23.80 to -14.98
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD2816 (4) (Comparator)Primary Vaccination Cohort:- AZD2816 (4) (Reference)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)88.60 (84.74 to 91.76)49.42 (44.00 to 54.85)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) (Comparator) vs Primary Vaccination Cohort:- AZD2816 (4) (Reference) · Seroresponse difference: 39.18 · 95% CI 32.68 to 45.21
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
Percentage of participantsPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Comparator)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Reference)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)99.40 (97.85 to 99.93)99.40 (97.85 to 99.93)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Comparator) vs Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) (Reference) · Seroresponse difference: 0.00 · 95% CI -1.62 to 1.62
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionBooster Cohort:- AZD1222:AZD1222Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)185.70 (169.32 to 203.66)360.43 (324.90 to 399.84)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.52 · 95% CI 0.45 to 0.59
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
1/dilutionBooster Cohort:- AZD1222:AZD1222Historical Control
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control185.70 (169.32 to 203.66)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 vs Historical Control · Gmt ratio: 0.76 · 95% CI 0.68 to 0.86
SecondaryGMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816
1/dilutionBooster Cohort:- AZD1222:AZD2816 (Comparator)Booster Cohort:- AZD1222:AZD2816 (Reference)
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816341.96 (315.48 to 370.66)213.26 (197.45 to 230.34)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 (Comparator) vs Booster Cohort:- AZD1222:AZD2816 (Reference) · Gmt ratio: 1.60 · 95% CI 1.43 to 1.79
SecondaryGMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222
1/dilutionBooster Cohort:- AZD1222:AZD1222 (Comparator)Booster Cohort:- AZD1222:AZD1222 (Reference)
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222185.70 (169.32 to 203.66)246.45 (227.39 to 267.12)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 (Comparator) vs Booster Cohort:- AZD1222:AZD1222 (Reference) · Gmt ratio: 0.75 · 95% CI 0.67 to 0.85
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- AZD1222:AZD1222Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control65.96 (60.56 to 71.07)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 vs Historical Control · Seroresponse difference: -18.10 · 95% CI -24.13 to -12.10
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 Variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsBooster Cohort:- AZD1222:AZD1222Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)65.96 (60.56 to 71.07)51.45 (46.03 to 56.85)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: 14.50 · 95% CI 7.07 to 21.71
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- AZD1222:AZD1222Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control65.96 (60.56 to 71.07)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 vs Historical Control · Seroresponse difference: -18.10 · 95% CI -24.13 to -12.10
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816
Percentage of participantsBooster Cohort:- AZD1222:AZD2816 (Comparator)Booster Cohort:- AZD1222:AZD2816 (Reference)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD281682.81 (78.22 to 86.78)65.94 (60.46 to 71.12)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD2816 (Comparator) vs Booster Cohort:- AZD1222:AZD2816 (Reference) · Seroresponse difference: 16.87 · 95% CI 10.15 to 23.40
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- AZD1222:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- AZD1222:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222
Percentage of participantsBooster Cohort:- AZD1222:AZD1222 (Comparator)Booster Cohort:- AZD1222:AZD1222 (Reference)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD122265.96 (60.56 to 71.07)65.96 (60.56 to 71.07)
Statistical analysis
  • Booster Cohort:- AZD1222:AZD1222 (Comparator) vs Booster Cohort:- AZD1222:AZD1222 (Reference) · Seroresponse difference: 0.00 · 95% CI -7.21 to 7.21
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
1/dilutionBooster Cohort:- mRNA:AZD1222Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)718.90 (670.46 to 770.84)360.43 (324.90 to 399.84)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 2.00 · 95% CI 1.75 to 2.28
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
1/dilutionBooster Cohort:- mRNA:AZD1222Historical Control
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control718.90 (670.46 to 770.84)242.80 (224.82 to 262.23)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 vs Historical Control · Gmt ratio: 2.96 · 95% CI 2.64 to 3.32
SecondaryGMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD2816

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD2816
1/dilutionBooster Cohort:- mRNA:AZD2816 (Comparator)Booster Cohort:- mRNA:AZD2816 (Reference)
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD28161587.58 (1463.98 to 1721.61)1052.73 (974.55 to 1137.19)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 (Comparator) vs Booster Cohort:- mRNA:AZD2816 (Reference) · Gmt ratio: 1.51 · 95% CI 1.35 to 1.69
SecondaryGMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222
1/dilutionBooster Cohort:- mRNA:AZD1222 (Comparator)Booster Cohort:- mRNA:AZD1222 (Reference)
GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222718.90 (670.46 to 770.84)841.96 (790.34 to 896.96)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 (Comparator) vs Booster Cohort:- mRNA:AZD1222 (Reference) · Gmt ratio: 0.85 · 95% CI 0.78 to 0.94
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- mRNA:AZD1222Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control42.86 (36.99 to 48.88)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 vs Historical Control · Seroresponse difference: -41.20 · 95% CI -47.57 to -34.41
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 Variant.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)
Percentage of participantsBooster Cohort:- mRNA:AZD1222Primary Vaccination Cohort:- AZD1222 (4)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)57.50 (51.48 to 63.36)51.45 (46.03 to 56.85)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 vs Primary Vaccination Cohort:- AZD1222 (4) · Seroresponse difference: 6.05 · 95% CI -1.81 to 13.77
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and AZD1222 in Historical Control with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control
Percentage of participantsBooster Cohort:- mRNA:AZD1222Historical Control
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control57.50 (51.48 to 63.36)84.06 (80.58 to 87.13)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 vs Historical Control · Seroresponse difference: -26.56 · 95% CI -33.10 to -19.94
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD2816 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD2816 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816
Percentage of participantsBooster Cohort:- mRNA:AZD2816 (Comparator)Booster Cohort:- mRNA:AZD2816 (Reference)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD281680.51 (75.34 to 85.00)49.82 (43.78 to 55.86)
Statistical analysis
  • Booster Cohort:- mRNA:AZD2816 (Comparator) vs Booster Cohort:- mRNA:AZD2816 (Reference) · Seroresponse difference: 30.69 · 95% CI 22.94 to 37.90
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Booster Cohort:- mRNA:AZD1222 with response against B.1.351 variant is the comparator group and Booster Cohort:- mRNA:AZD1222 with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after second dose (Day 57)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222
Percentage of participantsBooster Cohort:- mRNA:AZD1222 (Comparator)Booster Cohort:- mRNA:AZD1222 (Reference)
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD122257.50 (51.48 to 63.36)42.86 (36.99 to 48.88)
Statistical analysis
  • Booster Cohort:- mRNA:AZD1222 (Comparator) vs Booster Cohort:- mRNA:AZD1222 (Reference) · Seroresponse difference: 14.64 · 95% CI 6.36 to 22.64
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after first dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29364.20 (330.75 to 401.04)433.42 (398.43 to 471.48)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.84 · 95% CI 0.74 to 0.96
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against B.1.351 variant.

Time frame:
28 days after first dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29398.60 (381.99 to 415.95)233.65 (226.02 to 241.54)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 1.71 · 95% CI 1.62 to 1.80
SecondaryGMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.

Time frame:
28 days after first dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29
1/dilutionPrimary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29261.55 (240.05 to 284.97)525.20 (481.75 to 572.58)
Statistical analysis
  • Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.50 · 95% CI 0.44 to 0.56
SecondaryGMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29

Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) is the reference group, both compared for response against the original Wuhan-Hu-1 strain.

Time frame:
28 days after first dose (Day 29)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29
1/dilutionPrimary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 (4)
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29177.02 (160.25 to 195.53)471.69 (420.91 to 528.59)
Statistical analysis
  • Primary Vaccination Cohort:- AZD2816 (4) vs Primary Vaccination Cohort:- AZD1222 (4) · Gmt ratio: 0.38 · 95% CI 0.32 to 0.44
SecondaryGMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816

Chimpanzee adenovirus Ox1 (ChAdOx1) vector nAb were measured by neutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.

Time frame:
Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)
Reported as:
Geometric mean · 1/dilution
GMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816
1/dilutionPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD2816
GMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD28162369.38 (2165.69 to 2592.23)1640.99 (1510.43 to 1782.83)1656.53 (1529.80 to 1793.75)2082.82 (787.88 to 5506.10)3830.85 (3574.28 to 4105.83)811.44 (721.11 to 913.08)
SecondaryPercentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816

Chimpanzee adenovirus Ox1 vector nAb were measured by neutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline.

Time frame:
Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816
Percentage of participantsPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD2816
Percentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD281689.43 (84.68 to 93.11)93.30 (89.20 to 96.20)91.39 (86.73 to 94.82)85.71 (42.13 to 99.64)62.07 (56.50 to 67.42)87.64 (83.15 to 91.28)
SecondaryGMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts

Severe acute respiratory syndrome-coronavirus-2 spike protein binding antibodies were measured by multiplexed immunoassay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information.

Time frame:
Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)
Reported as:
Geometric mean · 1/dilution
GMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts
1/dilutionPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
B.1.35128618.30 (25758.25 to 31795.92)29325.20 (26677.38 to 32235.81)23119.62 (20524.01 to 26043.50)43047.62 (37018.88 to 50058.17)14382.37 (13365.31 to 15476.82)16561.93 (15630.53 to 17548.83)45587.11 (42653.03 to 48723.02)65705.69 (62446.19 to 69135.33)
Wuhan-Hu-159332.38 (53222.73 to 66143.39)21570.78 (19701.94 to 23616.89)38145.52 (33713.61 to 43160.03)25672.89 (21953.82 to 30021.99)34214.45 (31691.34 to 36938.43)29254.7 (27650.20 to 30952.30)106061.18 (98649.55 to 114029.66)113358.29 (107769.93 to 119236.43)
SecondaryPercentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts

Severe acute respiratory syndrome-coronavirus-2 spike protein binding antibodies were measured by multiplexed immunoassay. Seroresponse was defined as \>= 4-fold increase in the GMT of spike protein binding antibodies from baseline.

Time frame:
Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts
Percentage of participantsPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
B.1.35197.10 (94.73 to 98.60)97.36 (95.05 to 98.79)93.99 (90.88 to 96.29)98.08 (94.48 to 99.60)70.82 (65.58 to 75.68)75.94 (70.87 to 80.52)30.47 (25.12 to 36.23)51.08 (45.04 to 57.10)
Wuhan-Hu-197.68 (95.48 to 98.99)95.01 (92.14 to 97.07)94.29 (91.23 to 96.53)96.15 (91.82 to 98.58)67.78 (62.44 to 72.80)64.69 (59.18 to 69.92)36.56 (30.90 to 42.51)41.01 (35.17 to 47.04)
SecondaryCorrelation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres

Severe acute respiratory syndrome-coronavirus-2 nAb and ChAdOx1 vector nAb were measured by pseudoneutralisation assay. Correlations were based on log2 titre values and assessed by using Spearman rank correlation for all cohorts except Primary Vaccination Cohort:- AZD2816 (12) for which Pearson correlation was used. The correlation coefficient is reported in values from +1 to -1 (+1= perfect association, 0 = no association, and -1= perfect negative association). The closer the correlation coefficient is to zero, weaker the association.

Time frame:
Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort)
Reported as:
Number · Correlation coefficient
Correlation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres
Correlation coefficientPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
B.1.351-0.1656 (-0.29 to -0.04)-0.0536 (-0.18 to 0.08)-0.0783 (-0.21 to 0.06)0.0253 (-0.74 to 0.76)0.2061 (0.10 to 0.31)0.2297 (0.12 to 33)0.0225 (-0.10 to 0.14)-0.0591 (-0.18 to 0.06)
Wuhan-Hu-1-0.1263 (-0.25 to 0.00)0.0006 (-0.13 to 0.13)-0.0162 (-0.15 to 0.12)-0.1460 (-0.81 to 0.69)0.1288 (0.02 to 0.23)0.1583 (0.05 to 0.26)0.0005 (-0.12 to 0.12)-0.0534 (-0.17 to 0.06)

Adverse events

Collected over During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Primary Vaccination Cohort:- AZD1222 (4)1/409 (0.2%)3/409 (0.7%)32/409 (7.8%)
Primary Vaccination Cohort:- AZD2816 (4)0/413 (0%)3/413 (0.7%)42/413 (10.2%)
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)0/411 (0%)5/411 (1.2%)42/411 (10.2%)
Primary Vaccination Cohort:- AZD2816 (12)0/208 (0%)2/208 (1%)30/208 (14.4%)
Booster Cohort:- AZD1222:AZD12220/373 (0%)6/373 (1.6%)39/373 (10.5%)
Booster Cohort:- AZD1222:AZD28161/375 (0.3%)8/375 (2.1%)37/375 (9.9%)
Booster Cohort:- mRNA:AZD12220/322 (0%)3/322 (0.9%)25/322 (7.8%)
Booster Cohort:- mRNA:AZD28160/323 (0%)5/323 (1.5%)27/323 (8.4%)
Most frequent serious events
Showing 10 of 37
Most frequent serious events
EventPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
PharyngotonsillitisInfections and infestations0/4090/4130/4111/2080/3730/3750/3220/323
PyelonephritisInfections and infestations0/4090/4130/4111/2080/3730/3750/3220/323
Tubo-ovarian abscessInfections and infestations0/4090/4130/4110/2080/3730/3751/3220/323
Invasive lobular breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/4090/4130/4110/2080/3730/3751/3220/323
Rectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/4090/4130/4110/2080/3730/3751/3220/323
AppendicitisInfections and infestations0/4091/4130/4110/2080/3730/3750/3221/323
Pleural effusionRespiratory, thoracic and mediastinal disorders0/4090/4130/4110/2080/3730/3750/3221/323
Diabetic footSkin and subcutaneous tissue disorders0/4090/4130/4110/2080/3730/3750/3221/323
Atrial fibrillationCardiac disorders0/4090/4130/4110/2080/3730/3750/3221/323
Myocardial infarctionCardiac disorders0/4090/4130/4110/2080/3730/3750/3221/323
Most frequent other events
Most frequent other events
EventPrimary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816
COVID-19Infections and infestations32/40942/41342/41130/20839/37337/37525/32227/323

Baseline characteristics

Full analysis set included all randomised participants who received study treatment, irrespective of their protocol adherence and continued participation in the study. Participants were analysed according to their randomised treatment assignment, irrespective of the treatment actually received.

Age, Continuous
Age, Continuous(Years)Primary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816Total
Mean29.1 ± 12.4829.7 ± 12.9528.0 ± 12.2328.8 ± 12.9859.7 ± 13.7260.4 ± 13.3055.3 ± 13.1955.9 ± 13.7343.2 ± 19.6
Sex: Female, Male
Sex: Female, Male(Participants)Primary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816Total
Female171169166851721721971921324
Male2382442451232012051251291510
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Primary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816Total
Hispanic or Latino23924625713181046901
Not Hispanic or Latino143148137703223312912921734
Unknown or Not Reported271917743362723199
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Primary Vaccination Cohort:- AZD1222 (4)Primary Vaccination Cohort:- AZD2816 (4)Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)Primary Vaccination Cohort:- AZD2816 (12)Booster Cohort:- AZD1222:AZD1222Booster Cohort:- AZD1222:AZD2816Booster Cohort:- mRNA:AZD1222Booster Cohort:- mRNA:AZD2816Total
American Indian or Alaska Native402200008
Asian3540101481357
Native Hawaiian or Other Pacific Islander000000000
Black or African American202192214982132714
White161166151863253282902881795
More than one race1123106012053
Unknown or Not Reported2827301636331918207
08

Study locations

35 sites
  • Research Site
    Brasilia, 70200-730, Brazil
  • Research Site
    Curitiba, 80810-050, Brazil
  • Research Site
    Natal, 59020-035, Brazil
  • Research Site
    Natal, 59025-050, Brazil
  • Research Site
    Porto Alegre, 90035-903, Brazil
  • Research Site
    Salvador, 40110-060, Brazil
  • Research Site
    Lublin, 20-362, Poland
  • Research Site
    Oświęcim, 32-600, Poland
  • Research Site
    Puławy, 24-100, Poland
  • Research Site
    Zamosc, 22-400, Poland
  • Research Site
    Bloemfontein, 9301, South Africa
  • Research Site
    Cape Town, 7500, South Africa
  • Research Site
    Johannesburg, 1818, South Africa
  • Research Site
    Johannesburg, 2013, South Africa
  • Research Site
    Johannesburg, 2092, South Africa
  • Research Site
    Somerset West, 7130, South Africa
  • Research Site
    Birmingham, B15 2TH, United Kingdom
  • Research Site
    Bournemouth, BH7 7DW, United Kingdom
  • Research Site
    Bristol, BS105NB, United Kingdom
  • Research Site
    Bristol, BS2 8BJ, United Kingdom
  • Research Site
    Edinburgh, EH16 4SA, United Kingdom
  • Research Site
    Harrow, HA1 3UJ, United Kingdom
  • Research Site
    Hull, HU3 2KZ, United Kingdom
  • Research Site
    London, E2 0HL, United Kingdom
  • Research Site
    London, NW1 2BH, United Kingdom
  • Research Site
    London, SE1 9RT, United Kingdom
  • Research Site
    London, SE5 9NU, United Kingdom
  • Research Site
    Manchester, M8 5RB, United Kingdom
  • Research Site
    Newcastle-upon-Tyne, NE1 4LP, United Kingdom
  • Research Site
    Nottingham, NG7 2QW, United Kingdom
  • Research Site
    Oxford, OX3 7EJ, United Kingdom
  • Research Site
    Plymouth, PL6 8DH, United Kingdom
  • Research Site
    Portsmouth, PO1 3HN, United Kingdom
  • Research Site
    Sheffield, S5 7AU, United Kingdom
  • Research Site
    Truro, TR1 3LJ, United Kingdom
09

References and documents

Study documents

  • Study protocol · Oct 11, 2021
  • Statistical analysis plan · Sep 23, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04973449
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 22, 2021
Start date
Jun 27, 2021
Primary completion
Feb 4, 2022
Completion
Aug 2, 2022
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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