Africa Medical and Behavioral Sciences Organization
This project was a Phase III, randomized, modified double-blind clinical trial (Study Code: VAT00008) conducted by Sanofi to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines in adults aged 18 and older. The study investigated both monovalent and bivalent vaccine formulations administered as a primary series or booster dose to protect against COVID-19. Ultimately, the research aimed to assess the vaccines' ability to prevent symptomatic infection and provide robust immune responses against emerging SARS-CoV-2 variants of concern
To evaluate the efficacy of two doses of SARS-CoV-2 recombinant protein vaccines (with adjuvant) in preventing symptomatic COVID-19 infection in SARS-CoV-2 naive adults.
To evaluate the non-inferiority or superiority of the immune response elicited by the vaccine formulations compared to a control or reference standard.
To evaluate the safety and tolerability profile of the vaccine candidates following each injection (including solicited local and systemic reactions, unsolicited adverse events, and serious adverse events).
To assess the efficacy of the vaccines against severe COVID-19 infection, hospitalization, and death.
To evaluate vaccine efficacy against specific emerging SARS-CoV-2 variants of concern.
To evaluate the immune response following a booster dose in individuals previously primed with authorized COVID-19 vaccines or natural infection.
Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study
Gustavo H Dayan, Nadine Rouphael, Stephen R Walsh, Aiying Chen, Nicole Grunenberg, Mary Allen, Johannes Antony, Amit Suresh Bhate, Tatiana Beresnev, Matthew I Bonaparte, Médéric Celle, Maria Angeles Ceregido, Lawrence Corey, Bo Fu, Marie-Helene Grillet, Maryam Keshtkar-Jahromi, Michal Juraska, Jia Jin Kee, Seyram Kaali, Marguerite Koutsoukos, Roger Masotti1, Nelson L Michael, Kathleen M Neuzil, Humberto Reynales, Merlin L Robb, Akiyoshi Uchiyama, Fredrick Sawe, Lode Schuerman, Rajeev Shrestha, Tina Tong, John Treanor, Carlos A Diazgranados, Roman M Chicz, Sanjay Gurunathan, Stephen Savarino, Saranya Sridhar; VAT00008 study team
EClinical Medicinine, 2023 · DOI: 10.1016/j.eclinm.2023.102168
Protocol Title
A parallel-group, Phase III, multi-stage, modified double-blind
Study Site
Nansana Clinical Research Site
Dr. Francis Kiweewa
Dr. Kigozi Godfrey
Board Member
Dr. Nakigozi Getrude
Board Member
Dr. Nalugoda Fred
Board Member
Sanofi Pasteur Inc.
Contact our research team to learn about eligibility and how to get involved.
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