CClinicalTrials.gg
Sign In
CompletedNCT04568031Updated Mar 1, 2024Results posted

Study of AZD1222 for the Prevention of COVID-19 in Japan

A Phase 1/2 interventional study of AZD1222 and 0.9% (w/v) saline in COVID-19, sponsored by AstraZeneca. Completed at 5 sites in Japan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by AstraZeneca · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.

02

Conditions studied

  • COVID-19

Browse trials for

Keywords

  • COVID-19 Vaccine
03

In context

COVID-19

7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.

This study's enrollment of 256 is above the median of 100 across 4,100 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 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Browse AstraZeneca studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants aged 18 to 55 years (Cohort A and C), aged 56 to 69 years (Subcohorts B1 and D1), or aged ≥ 70 years (Subcohorts B2 and D2)

Exclusion criteria

Exclusion Criteria:

  1. Known past laboratory-confirmed SARS-CoV-2 infection
  2. Positive SARS-CoV-2 RT PCR test at screening
  3. Seropositivity to SARS-CoV-2 at screening.
  4. Significant infection or other illness, including fever > 37.8°C on the day prior to or day randomization
  5. History of Guillain-Barré syndrome
  6. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days)
  7. History of allergy to any component of the vaccine
  8. Any history of angioedema
  9. Any history of anaphylaxis
  10. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ)
  11. History of serious psychiatric condition likely to affect participation in the study
  12. Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
  13. Suspected or known current alcohol or drug dependency
  14. Any other significant disease, disorder or finding which 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
  15. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
256 participants (actual)

Study arms

  • Active comparator
    Part I

    Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years.

    Drug: AZD1222

  • Placebo comparator
    Part II

    Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years.

    Drug: 0.9% (w/v) saline

Interventions

  • DrugAZD1222

    For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2

  • Drug0.9% (w/v) saline

    For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay

    Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is \>= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (\>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the S antigen of AZD1222 as measured by MSD serology assay is reported.

    Time frame: Baseline (Day 1) and Day 57

  2. Number of Participants With Local Solicited Adverse Events (AE)

    Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.

    Time frame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days

  3. Number of Participants With Systemic Solicited AEs

    Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.

    Time frame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days

  4. Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination

    An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.

    Time frame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days

  5. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

    Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology and clinical chemistry. The baseline was defined as the last non-missing measurement taken prior to the first dose of study vaccination (including unscheduled measurements, if any).

    Time frame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days

Secondary outcomes

  1. Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay

    Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is \>= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (\>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the RBD antigen of AZD1222 as measured by MSD serology assay is reported.

    Time frame: Baseline (Day 1) and Day 57

  2. Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

    The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

    Time frame: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365

  3. Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

    The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

    Time frame: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365

  4. Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay

    Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is \>= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (\>= 4-fold rise in titers from Day 1 baseline value to Day 57) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported.

    Time frame: Baseline (Day 1) and Day 57

  5. GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay

    The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

    Time frame: Baseline (Day 1) and Days 29, 57, 183, and 365

  6. GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay

    The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

    Time frame: Baseline (Day 1) and Days 29, 57, 183, and 365

  7. Number of Participants With SAEs and AESIs Occurring Throughout the Study

    An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.

    Time frame: From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days

07

Results

Posted Mar 1, 2024

Participant flow

This Phase I/II study was conducted in healthy, severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) naïve participants at 5 study centers in Japan. First participant was randomized on 23 August 2020 and final data cut-off (DCO) date was 17 January 2022.

Participant flow — Overall Study
MilestoneCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Started96329632
Participants received 1 vaccination96329632
Participants received 2 vaccinations84309231
Completed93329131
Not completed3051
Withdrew: Lost to follow-up1000
Withdrew: Physician decision1010
Withdrew: Withdrawal by subject1041

Outcome measures

PrimaryPercentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay

Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is \>= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (\>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the S antigen of AZD1222 as measured by MSD serology assay is reported.

Time frame:
Baseline (Day 1) and Day 57
Reported as:
Number · percentage of participants
Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay
percentage of participantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay100.00.0100.00.0
Statistical analysis
  • Cohort C: AZD1222 vs Cohort C: Placebo · Fisher Exact · p = < 0.001
  • Cohort D: AZD1222 vs Cohort D: Placebo · Fisher Exact · p = < 0.001
PrimaryNumber of Participants With Local Solicited Adverse Events (AE)

Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.

Time frame:
From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
Reported as:
Count of participants · Participants
Number of Participants With Local Solicited Adverse Events (AE)
ParticipantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
After first vaccination704462
After second vaccination373360
After any vaccination745532
PrimaryNumber of Participants With Systemic Solicited AEs

Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.

Time frame:
From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
Reported as:
Count of participants · Participants
Number of Participants With Systemic Solicited AEs
ParticipantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
After first vaccination656413
After second vaccination307243
After any vaccination6811475
PrimaryNumber of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination

An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.

Time frame:
From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
Reported as:
Count of participants · Participants
Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination
ParticipantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
AEs284229
SAEs0131
AESIs0000
PrimaryNumber of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology and clinical chemistry. The baseline was defined as the last non-missing measurement taken prior to the first dose of study vaccination (including unscheduled measurements, if any).

Time frame:
From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
ParticipantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters0000
SecondaryPercentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay

Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is \>= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (\>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the RBD antigen of AZD1222 as measured by MSD serology assay is reported.

Time frame:
Baseline (Day 1) and Day 57
Reported as:
Number · percentage of participants
Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay
percentage of participantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay100.00.0100.00.0
Statistical analysis
  • Cohort C: AZD1222 vs Cohort C: Placebo · Fisher Exact · p = < 0.001
  • Cohort D: AZD1222 vs Cohort D: Placebo · Fisher Exact · p = < 0.001
SecondaryGeometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

Time frame:
Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
Reported as:
Geometric mean · arbitrary units per milliliter (AU/mL)
Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
arbitrary units per milliliter (AU/mL)Cohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
S Antibody Titer: Baseline (Day 1)62.18 (48.136 to 80.310)46.00 (32.713 to 64.672)39.06 (31.824 to 47.931)39.87 (24.214 to 65.662)
S Antibody Titer: Day 152520.37 (1868.317 to 3399.988)43.70 (31.600 to 60.426)999.28 (751.737 to 1328.342)39.24 (24.016 to 64.105)
S Antibody Titer: Day 297971.03 (6278.011 to 10120.625)42.66 (30.843 to 58.993)6720.46 (5361.399 to 8424.022)40.03 (24.956 to 64.223)
S Antibody Titer: Day 4317708.74 (14671.831 to 21374.262)41.61 (29.411 to 58.879)15594.37 (12792.879 to 19009.367)37.89 (23.025 to 62.344)
S Antibody Titer: Day 5714986.27 (12455.149 to 18031.758)44.24 (31.816 to 61.507)12824.27 (10516.280 to 15638.797)38.75 (23.604 to 63.618)
S Antibody Titer: Day 1834454.01 (3503.969 to 5661.645)53.28 (36.416 to 77.945)3424.65 (2758.191 to 4252.152)45.89 (28.326 to 74.347)
S Antibody Titer: Day 3653691.12 (2468.353 to 5519.626)760.64 (0.002 to 266254529.058)2691.98 (1910.675 to 3792.785)116.38 (0.611 to 22179.458)
RBD Antibody Titer: Baseline (Day 1)122.62 (106.105 to 141.715)114.89 (96.952 to 136.148)105.41 (100.326 to 110.752)119.83 (97.625 to 147.077)
RBD Antibody Titer: Day 15945.33 (678.340 to 1317.392)116.04 (96.504 to 139.521)430.65 (329.174 to 563.418)118.91 (97.844 to 144.520)
RBD Antibody Titer: Day 296466.23 (5026.530 to 8318.284)115.39 (96.817 to 137.518)5616.00 (4468.764 to 7057.759)116.63 (94.796 to 143.491)
RBD Antibody Titer: Day 4320719.36 (17079.781 to 25134.511)114.43 (97.164 to 134.766)17677.04 (14383.279 to 21725.058)123.20 (100.706 to 150.715)
RBD Antibody Titer: Day 5716775.12 (13921.806 to 20213.221)114.54 (97.063 to 135.156)14094.42 (11437.864 to 17367.992)116.24 (96.030 to 140.713)
RBD Antibody Titer: Day 1834245.22 (3309.128 to 5446.106)111.24 (98.273 to 125.916)3354.78 (2646.741 to 4252.239)127.71 (95.347 to 171.052)
RBD Antibody Titer: Day 3653550.69 (2296.498 to 5489.828)1520.17 (0.014 to 169886733.576)2643.76 (1811.827 to 3857.686)304.93 (9.346 to 9948.763)
SecondaryGeometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

Time frame:
Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
Reported as:
Geometric mean · ratio
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
ratioCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
S Antibody Titer: Day 1540.54 (30.451 to 53.962)0.95 (0.863 to 1.046)25.59 (18.465 to 35.453)0.98 (0.865 to 1.119)
S Antibody Titer: Day 29128.20 (97.728 to 168.179)0.93 (0.841 to 1.023)172.07 (128.206 to 230.951)1.00 (0.869 to 1.161)
S Antibody Titer: Day 43284.82 (217.685 to 372.656)0.90 (0.814 to 1.006)399.28 (295.200 to 540.068)0.95 (0.842 to 1.072)
S Antibody Titer: Day 57241.03 (183.977 to 315.781)0.96 (0.881 to 1.050)328.36 (243.794 to 442.254)0.97 (0.858 to 1.100)
S Antibody Titer: Day 18370.49 (51.130 to 97.171)1.11 (0.920 to 1.344)88.17 (65.621 to 118.464)1.15 (1.021 to 1.298)
S Antibody Titer: Day 36559.15 (37.619 to 93.012)25.12 (0.000 to 26524735.936)70.56 (47.647 to 104.486)4.18 (0.042 to 416.314)
RBD Antibody Titer: Day 157.71 (5.690 to 10.445)1.01 (0.995 to 1.025)4.09 (3.140 to 5.315)0.99 (0.972 to 1.013)
RBD Antibody Titer: Day 2952.73 (40.850 to 68.070)1.00 (0.985 to 1.024)53.28 (42.740 to 66.413)0.97 (0.915 to 1.035)
RBD Antibody Titer: Day 43168.97 (134.602 to 212.105)1.00 (0.983 to 1.009)167.70 (137.013 to 205.253)1.03 (0.966 to 1.095)
RBD Antibody Titer: Day 57136.80 (109.050 to 171.614)1.00 (0.992 to 1.002)133.71 (108.961 to 164.080)0.97 (0.911 to 1.033)
RBD Antibody Titer: Day 18334.54 (26.040 to 45.820)0.96 (0.891 to 1.023)31.81 (25.259 to 40.071)1.07 (0.888 to 1.279)
RBD Antibody Titer: Day 36528.76 (18.123 to 45.629)14.90 (0.000 to 1665556.212)25.03 (17.383 to 36.049)2.99 (0.092 to 97.537)
SecondaryPercentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay

Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is \>= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (\>= 4-fold rise in titers from Day 1 baseline value to Day 57) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported.

Time frame:
Baseline (Day 1) and Day 57
Reported as:
Number · percentage of participants
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay
percentage of participantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay67.50.057.00.0
Statistical analysis
  • Cohort C: AZD1222 vs Cohort C: Placebo · Fisher Exact · p = < 0.001
  • Cohort D: AZD1222 vs Cohort D: Placebo · Fisher Exact · p = < 0.001
SecondaryGMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay

The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.

Time frame:
Baseline (Day 1) and Days 29, 57, 183, and 365
Reported as:
Geometric mean · AU/mL
GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
AU/mLCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Baseline (Day 1)20.84 (19.206 to 22.604)20.00 (NA to NA)20.00 (NA to NA)20.82 (19.175 to 22.616)
Day 2967.26 (50.689 to 89.249)20.00 (NA to NA)46.11 (36.577 to 58.132)21.07 (18.947 to 23.422)
Day 57107.30 (84.198 to 136.741)20.00 (NA to NA)90.00 (70.051 to 115.618)20.00 (NA to NA)
Day 18331.14 (24.679 to 39.281)20.00 (NA to NA)28.91 (24.717 to 33.810)20.54 (19.448 to 21.703)
Day 36543.16 (28.917 to 64.428)97.03 (0.109 to 86708.084)32.44 (24.376 to 43.159)25.40 (11.875 to 54.316)
SecondaryGMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay

The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.

Time frame:
Baseline (Day 1) and Days 29, 57, 183, and 365
Reported as:
Geometric mean · ratio
GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
ratioCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
Day 293.21 (2.469 to 4.184)1.00 (NA to NA)2.31 (1.829 to 2.907)1.01 (0.988 to 1.036)
Day 575.14 (4.066 to 6.503)1.00 (NA to NA)4.50 (3.503 to 5.781)1.00 (NA to NA)
Day 1831.49 (1.186 to 1.879)1.00 (NA to NA)1.45 (1.236 to 1.690)0.99 (0.960 to 1.014)
Day 3652.06 (1.379 to 3.088)4.85 (0.005 to 4335.404)1.62 (1.219 to 2.158)1.27 (0.594 to 2.716)
SecondaryNumber of Participants With SAEs and AESIs Occurring Throughout the Study

An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.

Time frame:
From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days
Reported as:
Count of participants · Participants
Number of Participants With SAEs and AESIs Occurring Throughout the Study
ParticipantsCohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: Placebo
SAEs0231
AESIs0100

Adverse events

Collected over AEs are reported from first administration of study vaccination up to final DCO of 17 January 2022, up to a maximum of 365 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohorts C + D: AZD12220/192 (0%)3/192 (1.6%)11/192 (5.7%)
Cohorts C + D: Placebo0/64 (0%)3/64 (4.7%)0/64 (0%)
Most frequent serious events
Most frequent serious events
EventCohorts C + D: AZD1222Cohorts C + D: Placebo
Sinus node dysfunctionCardiac disorders0/1921/64
Anaphylactic reactionImmune system disorders0/1921/64
Cervical dysplasiaReproductive system and breast disorders0/1921/64
Bile duct stoneHepatobiliary disorders1/1920/64
PneumoniaInfections and infestations1/1920/64
Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1920/64
Small intestine carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1920/64
Cerebral haemorrhageNervous system disorders1/1920/64
Most frequent other events
Most frequent other events
EventCohorts C + D: AZD1222Cohorts C + D: Placebo
TendernessGeneral disorders11/1920/64

Baseline characteristics

The Total vaccinated analysis set (TVS) included all participants who received at least 1 dose of study vaccination.

Age, Categorical
Age, Categorical(Participants)Cohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: PlaceboTotal
<=18 years00000
Between 18 and 65 years96325114193
>=65 years00451863
Sex: Female, Male
Sex: Female, Male(Participants)Cohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: PlaceboTotal
Female258401487
Male71245618169
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: PlaceboTotal
Asian96329632256
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort C: AZD1222Cohort C: PlaceboCohort D: AZD1222Cohort D: PlaceboTotal
Hispanic or Latino00000
Not Hispanic or Latino96329632256
08

Study locations

5 sites
  • Research Site
    Fukuoka-shi, 810-0021, Japan
  • Research Site
    Hachioji-shi, 192-0046, Japan
  • Research Site
    Minato-ku, 108-0075, Japan
  • Research Site
    Sumida-ku, 130-0004, Japan
  • Research Site
    Toshima-ku, 171-0021, Japan
09

References and documents

Publications

  • Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, Matsui A, Kelly EJ, Shoemaker K, Olsson U, Vekemans J. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 2021 Oct 22. PubMed 34688944 ↗

Study documents

  • Study protocol · Jan 18, 2021
  • Statistical analysis plan · Dec 9, 2021

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 Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04568031
Lead sponsor
AstraZeneca
Collaborators
Iqvia Pty Ltd
Responsible party
Sponsor
First posted
Sep 29, 2020
Start date
Aug 23, 2020
Primary completion
Nov 22, 2021
Completion
Nov 22, 2021
Results posted
Mar 1, 2024
Last update
Mar 1, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

AstraZeneca→

Start the discussion