COVID-19Phase 3NCT05715944
Incidence of COVID-19 Following Vaccination in Botswana Against SARS CoV 2
A Phase 3 study testing AZD 1222 in people with COVID-19, run by Botswana Harvard AIDS Institute Partnership at 1 site in Botswana.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AZD 1222
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,888 participants
- Where
- 1 siteBotswana
- Study dates
- 15 Sep 2021to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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, AZD1222 - ESR-21-21311
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
- COVID-19
- Being tested
- AZD 1222
- Keywords
- AZD 1222, ChAdOx1
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD 1222Drug
Also called ChAdOx1 nCoV-19
Vaccine
| Study group | Role | What they receive |
|---|---|---|
| AZD 1222 | Experimental | 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 Receives: Drug: AZD 1222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222,
Occurrence of hospitalizations and deaths due to laboratory-confirmed SARS CoV 2 infection
Measured: 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
Measured: Up to 12 months following the first vaccination dose
Secondary outcomes (2)
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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Sep 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- AZD1222-00001 is a single-arm, Open-label, Phase 3b Study of the Incidence of Severe COVID 19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2. Study participants are adults ≥ 18 years of age who have not already received a COVID-19 vaccine primary series and/or booster. Up to 50,000 participants are to be enrolled in the study. A total of 900 enrolled participants will also participate in a sub-study assessing the immunogenicity of AZD1222. These 900 participants in the sub-cohort will have additional assessments. Safety is assessed for the duration of the study. AEs are recorded at 4 weeks post the first, second and booster vaccination dose and quarterly; participants are contacted via text, or telephone call as part of follow up.
- Masking
- None (open label)
- Enrolment
- 10,888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botswana Harvard AIDS Institute Partnership
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Botswana Ministry of Health
- Responsible party
- Principal investigator, Joseph M Makhema, Botswana Harvard AIDS Institute Partnership
- Investigators
- Joseph M Makhema, FRCP, Principal investigator, Botswana Harvard AIDS Institute PartnershipTendani Gaolathe, M.,Med, Study director, University of Botswana, Botswana Harvard Health Partnership
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715944
- Sponsor's protocol ID
- BHP150
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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, AZD1222 - ESR-21-21311
- ClinicalTrials.gov ID
- NCT05715944
- Acronym / sponsor ID
- BHP150
- Conditions
- COVID-19
- Keywords
- AZD 1222, ChAdOx1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,888 participants (actual)
- Lead sponsor
- Botswana Harvard AIDS Institute PartnershipUniversity, hospital or other
- Collaborators
- AstraZeneca, Botswana Ministry of Health
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AZD1222-00001 is a single-arm, Open-label, Phase 3b Study of the Incidence of Severe COVID 19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2. Study participants are adults ≥ 18 years of age who have not already received a COVID-19 vaccine primary series and/or booster. Up to 50,000 participants are to be enrolled in the study. A total of 900 enrolled participants will also participate in a sub-study assessing the immunogenicity of AZD1222. These 900 participants in the sub-cohort will have additional assessments. Safety is assessed for the duration of the study. AEs are recorded at 4 weeks post the first, second and booster vaccination dose and quarterly; participants are contacted via text, or telephone call as part of follow up.
| Arm | Type | Receives |
|---|---|---|
| AZD 1222 | Experimental | Drug: AZD 1222AZD1222 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD 1222Also: ChAdOx1 nCoV-19Vaccine | Drug | AZD 1222 |
Primary outcome
Occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222,
Time frame: From at least 15 days after the second or booster dose up to 12 months following the first vaccination dose
Occurrence of hospitalizations and deaths due to laboratory-confirmed SARS CoV 2 infection
Occurrence of Adverse Events among individuals vaccinated with at least one dose AZD1222
Time frame: Up to 12 months following the first vaccination dose
Occurrence of Serious Adverse Events and Adverse Events of Special Interest up to 12 months following the first vaccination dose
2 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Makhema, FRCP principal investigator
Botswana Harvard AIDS Institute Partnership
Tendani Gaolathe, M.,Med study director
University of Botswana, Botswana Harvard Health Partnership
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZD 1222 in people with COVID-19, run by Botswana Harvard AIDS Institute Partnership at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222, (time frame: From at least 15 days after the second or booster dose up to 12 months following the first vaccination dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.