CompletedNCT05715944Updated Feb 8, 2023

Incidence of COVID-19 Following Vaccination in Botswana Against SARS CoV 2

A Phase 3 interventional study of AZD 1222 in COVID-19, sponsored by Botswana Harvard AIDS Institute Partnership. Completed at 1 site in Botswana. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Botswana Harvard AIDS Institute Partnership · Phase 3, Interventional, and Prevention

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Sep 2021, registered Nov 2022).

Phase: Phase 3
Study type: Interventional
Enrollment: 10,888
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The AstraZeneca Study is a single-arm, open-label, interventional, Phase 3b study to determine the incidence of laboratory-confirmed COVID-19 hospitalizations, disease severity, and deaths and attributable adverse events (AEs) in participants in Botswana given 1 to 2 injections of AZD1222 eight to twelve weeks apart as primary series and/or 1 injection as booster dose. Length of follow-up will be 6 to 12 months, depending upon at which dose a participant is enrolled.

Read the detailed description

The AstraZeneca Study is an Open-Label, Single-Arm, Phase 3b Study of the incidence of severe COVID-19 and adverse events following AZD1222 COVID-19 vaccination in Botswana against SARS-CoV-2. The study enrolled adult participants >18 years (previously >40 years) in Botswana and vaccinate them with 1 to 2 doses of AZD 1222, as primary series and/or 1 dose as booster.

Primary Objectives:

To assess the occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses.
To assess AEs among individuals vaccinated with at least one dose of AZD1222.

Secondary Objectives:

To assess the occurrence of COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses by age group, co-morbidity group, the severity of disease and the time since the last dose.
To estimate the incidence of symptomatic SARS-CoV-2 infections in a sub-cohort of study participants among individuals vaccinated with at least one dose of AZD1222 by number of vaccine doses

Conditions studied

COVID-19

Browse trials for

COVID-19 7,640

Keywords

AZD 1222
ChAdOx1

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 10,888 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Botswana Harvard AIDS Institute Partnership is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

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

Who can participate

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

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Type of Participant

Participants who have willingness and ability to comply with study requirements/procedures (if applicable, with assistance by legally authorised representative) based on the assessment of the investigator.
Participants who have not yet received 3 doses of COVID-19 vaccine (2 as primary series and a booster dose). Persons who have received no prior vaccination are eligible to enroll at Day 0 to start a primary series. Persons who have received a single dose of COVID-19 vaccine at least 8 week prior (note that this includes persons who have received a single dose of Johnson \& Johnson vaccine) are eligible to enroll at Day 70 to complete their primary series and receive a booster dose 3 months thereafter. Persons who have received a primary series of COVID-19 vaccine at least 3 months prior are eligible to enroll at Day 170 to receive a booster.
Informed Consent
Capable of giving signed informed consent, as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Note: A separate informed consent will be used for optional sample collection.
Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
Age
Participant must be ≥ 18years of age at the time of signing the informed consent and residing in the catchment area of select hospitals in Botswana.

Exclusion criteria

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Prior/Concomitant Therapy

Receipt of, or planned receipt of a COVID-19 vaccine booster dose, or any medications or investigational products indicated for the prevention of SARS-CoV-2 infection or treatment of COVID-19.
Note: For study participants who become hospitalised with COVID-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted.
Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention (i.e. the first, second and booster doses). Outside these periods, other routine vaccinations are permitted as clinically indicated.
Medical Conditions
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
The participant reports being pregnant or nursing or has a positive pregnancy test at the time of enrolment or is planning on becoming pregnant within 6 months (for those enrolled at primary series dose 1) or 3 months (for those enrolled at primary series dose 2) of the first vaccination in the study.
Additional details are described in Section 5.2.1.
Individuals with risk factors for or reported history of thrombosis and/or thrombocytopenia.
Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following intramuscular injections or venepuncture.
History of Guillain-Barré syndrome.
Any confirmed or suspected immunosuppressive or immunodeficient state, including Asplenia.
Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed).
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.
Note: The AESIs as outlined in the CSP should be considered when evaluating a participant for this Exclusion Criteria as the presence of these AESIs, especially if untreated or uncontrolled, may be a safety risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
Other Criteria
Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the investigator/designee.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10,888 participants (actual)

Study arms

Experimental
AZD 1222
AZD1222 vaccine Dose Formulation: 10 mM histidine, 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 Current/Former names/alias(es):ChAdOx1 nCoV-19
Drug: AZD 1222

Interventions

DrugAZD 1222
Vaccine
Also known as: ChAdOx1 nCoV-19

What researchers measure

Primary outcomes

Occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222,
Occurrence of hospitalizations and deaths due to laboratory-confirmed SARS CoV 2 infection
Time frame: From at least 15 days after the second or booster dose up to 12 months following the first vaccination dose
Occurrence of Adverse Events among individuals vaccinated with at least one dose AZD1222
Occurrence of Serious Adverse Events and Adverse Events of Special Interest up to 12 months following the first vaccination dose
Time frame: Up to 12 months following the first vaccination dose

Secondary outcomes

Occurrence of COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses and vaccine exposure, by age group, comorbidity group, severity of disease, and the time since the last dose
* Occurrence of hospitalizations and deaths due to laboratory-confirmed SARS-CoV-2 infection from at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose, by age group, comorbidity group, severity of disease, number of vaccine doses, and the time since the last dose * Occurrence of laboratory-confirmed symptomatic infection from at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose, by age group, comorbidity group, severity of disease, number of vaccine doses, and the time since the first or second dose
Time frame: From at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose,
Incidence of symptomatic SARS-CoV-2 infections in a sub-cohort of study participants among individuals vaccinated with at least one dose of AZD1222, by number of vaccine doses, and by vaccine exposure
• Occurrence of laboratory-confirmed symptomatic infection from at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose
Time frame: From at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose

Other outcomes

Comparing the primary endpoint of incidence of severe COVID-19 cases to the incidence before vaccination using an observed versus expected method
• Occurrence of hospitalizations and deaths in subjects vaccinated with AZD1222 vaccine as a primary COVID-19 vaccination series or booster dose due to laboratory-confirmed SARSCoV2 infection from at least 15 days after the last dose up to 6-12 months following the first vaccination dose received as part of the study, and the occurrence in 3-month and 6-month periods before the introduction of the AZD1222 vaccine
Time frame: From at least 15 days after the last dose up to 6-12 months following the first vaccination dose received as part of the study
Monitoring the genetic diversity of breakthrough SARS-CoV-2 infections in a sub-cohort of study participants
• Genotypic analysis of SARS-CoV-2 from swabs collected for severe COVID-19 cases and on Day 1 illness visit in infected study participants in the sub-cohort
Time frame: Follow up of up to one year
Estimating the occurrence of SARS-CoV-2 infections in a sub-cohort of study participants
• The incidence of SARS-CoV-2 infection defined by the presence of nucleocapsid antibodies occurring post-dose of study intervention
Time frame: Follow up of up to one year
Assessing the humoral immunogenicity of AZD1222 vaccinated participants over time in a sub-cohort of study participants
* Magnitude of SARS-CoV-2 specific antibody binding and neutralization titres (geometric mean titre) * Seroresponse rate of SARS-CoV-2 specific antibody binding and neutralization titres
Time frame: Follow up of up to one year
Assessing cell mediated immune responses of AZD1222 vaccinated participants over time in a sub-cohort of study participants
• Quantification of (IFN-γ) ELISpot responses to SARS-CoV-2 S protein
Time frame: Follow up of up to one year
Assessing additional immune responses following AZD1222 vaccine as a primary COVID-19 vaccination series or as a booster
• Other exploratory assays for humoral and cellular immune responses may be performed based upon emerging safety, efficacy, and immunogenicity data
Time frame: Follow up of up to one year

Study locations

1 site

Botswana Harvard Health Partnership
Gaborone, Botswana

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05715944
Lead sponsor: Botswana Harvard AIDS Institute Partnership
Collaborators: AstraZeneca, Botswana Ministry of Health
Responsible party: Joseph M Makhema (Principal Investigator, Botswana Harvard AIDS Institute Partnership) — Principal investigator
First posted: Feb 8, 2023
Start date: Sep 15, 2021
Primary completion: Dec 30, 2022
Completion: Dec 30, 2022
Last update: Feb 8, 2023

Study contacts

Joseph M Makhema, FRCP

principal investigator · Botswana Harvard AIDS Institute Partnership

Tendani Gaolathe, M.,Med

study director · University of Botswana, Botswana Harvard Health Partnership

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 Feb 2023. You cannot join it, but the record below documents what was studied.

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