COVID-19
Conditions
Interventions
Bivalent BNT162b2
Sponsors
OXFORD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult (?18 years of age) males, or non-pregnant females. 2) Able and willing to comply with trial requirements. 3) For females only, a negative pregnancy test within 24 hours prior to administration of each of the two vaccine doses and willing to take contraception till 28 days after the second vaccine dose. 4) Provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Documented history of any COVID-19 vaccination. 2) Prior receipt of an investigational, or licensed vaccine within the last 30 days. 3) Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the first vaccine dose. 4) Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection; 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). 5) History of allergic disease, or reactions that could be exacerbated by any component of study vaccine. 6) Any history of angioedema or anaphylaxis. 7) Any history of myocarditis and pericarditis. 8) Pregnancy or lactation at the time of screening. 9) Bleeding disorders, or other conditions that in the opinion of the investigator contraindicate intramuscular injection. 10) Any other conditions that in the opinion of the investigator may jeopardise participant safety and / or interfere with study outcomes 11) Participating, or planned participation in another concurrent interventional research study. 12) Acute febrile, or other significant, illness that may affect the conduct of the trial as judged by the study clinician (e.g., diarrhoeal illness).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine superiority of the immune response against the Omicron BA.4/BA.5 sub lineage of SARS-CoV-2, measured as day 28 neutralising antibodies (Nabs) GMT in previously COVID-19 unvaccinated healthy East African adults following vaccinations with two doses of the Omicron BA.4/BA.5 adapted Bivalent BNT162b2 COVID-19 vaccine (28 days apart), versus two doses of the Original BNT162b2 COVID-19 vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare the safety and reactogenicity between the two trial vaccination arms following each of two successive doses of the Bivalent BNT162b2 and the Original BNT162b2vaccines in previously COVID-19 unvaccinated adults | — |
Countries
Kenya, United Republic of Tanzania
Contacts
Public ContactStella Mwakio
Project Manager
Outcome results
None listed