drugset / Trial / NCT02876328
Partnership for Research on Ebola VACcinations
Phase 2
Completed
4789 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
European and Developing Countries Clinical Trials Partnership (EDCTP) · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabLondon School of Hygiene and Tropical Medicine · collabPartnership for Research on Ebola Virus in Liberia (PREVAIL) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.
Timeline
- Start
- 2017-03-27
- Primary completion
- 2019-12-24
- Completion
- 2023-12-20
Outcome
Met primary endpoint
registry Protocol Version 4.0 Ad26/MVA vs Protocol Version 4.0 rVSV vs Protocol Version 4.0 rVSV Boost vs Protocol Version 4.0 Pooled Placebo; p <.001; NCT02876328 ↗
paper P<0.001 for all comparisons of vaccine with placebo). PMID 36516078 ↗
Publications
- Results Badio M, Lhomme E, Kieh M, Beavogui AH, Kennedy SB, Doumbia S, Leigh B, Sow SO, Diallo A, Fusco D, Kirchoff M, Termote M, Vatrinet R, Wentworth D, Esperou H, Lane HC, Pierson J, Watson-Jones D, Roy C, D'Ortenzio E, Greenwood B, Chene G, Richert L, Neaton JD, Yazdanpanah Y; PREVAC study team. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Trials. 2021 Jan 23;22(1):86. doi: 10.1186/s13063-021-05035-9.
- Results PREVAC Study Team; Kieh M, Richert L, Beavogui AH, Grund B, Leigh B, D'Ortenzio E, Doumbia S, Lhomme E, Sow S, Vatrinet R, Roy C, Kennedy SB, Faye S, Lees S, Millimouno NP, Camara AM, Samai M, Deen GF, Doumbia M, Esperou H, Pierson J, Watson-Jones D, Diallo A, Wentworth D, McLean C, Simon J, Wiedemann A, Dighero-Kemp B, Hensley L, Lane HC, Levy Y, Piot P, Greenwood B, Chene G, Neaton J, Yazdanpanah Y. Randomized Trial of Vaccines for Zaire Ebola Virus Disease. N Engl J Med. 2022 Dec 29;387(26):2411-2424. doi: 10.1056/NEJMoa2200072. Epub 2022 Dec 14.
- Beavogui AH, Doumbia S, Kieh M, Leigh B, Sow S, Lhomme E, Ben-Farhat S, Dubois Cauwelaert N, Roy C, Diouf W, Idrissa S, Diarra S, Millimouno NP, Diallo FA, Kamara M, Pratt D, Dicko I, Kennedy SB, Esperou H, Choi EM, Kpetigo AD, D'Ortenzio E, Diallo A, Lancrey-Javal S, Hamze B, Schwimmer C, Wiedemann A, Ayouba A, Peeters M, Lane HC, Higgs E, Watson-Jones D, Yazdanpanah Y, Greenwood B, Richert L, Levy Y; PREVAC study Team. Five-year immunogenicity and safety follow-up of the PREVAC randomized Trial of Vaccines for Zaire Ebola Virus Disease. medRxiv [Preprint]. 2026 Jun 8:2026.05.29.26354050. doi: 10.64898/2026.05.29.26354050.
- Kpetigo AD, Alexandre M, Camara A, Beavogui A, Doumbia S, Kieh M, Leigh B, Sow S, Wittkop L, Soutthiphong AA, Berry IM, Fleck S, Akoo P, Hamze B, Watson-Jones D, Kuhn JH, Greenwood B, Richert L, Yazdanpanah Y, Levy Y, Thiebaut R, Prague M; PREVAC Study Team; Lhomme E. Effect of the time of day for vaccination on the immune response to Ebola Virus Disease vaccines: A modeling study from PREVAC randomized trial. PLoS Negl Trop Dis. 2026 Jan 30;20(1):e0013950. doi: 10.1371/journal.pntd.0013950. eCollection 2026 Jan.
- Valayer S, Alexandre M, Prague M, Beavogui AH, Doumbia S, Kieh M, Greenwood B, Leigh B, Poupelin M, Schwimmer C, Sow SO, Berry IM, Kuhn JH, Fusco D, Cauwelaert ND, Watson-Jones D, Thiebaut R, Levy Y, Yazdanpanah Y, Richert L, Lhomme E; PREVAC study team. Evaluation of waning of IgG antibody responses after rVSVDeltaG-ZEBOV-GP and Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccines: a modelling study from the PREVAC randomized trial. Emerg Microbes Infect. 2025 Dec;14(1):0. doi: 10.1080/22221751.2024.2432353. Epub 2024 Dec 9.
- Wiedemann A, Lhomme E, Huchon M, Foucat E, Bererd-Camara M, Guillaumat L, Yaradouno M, Tambalou J, Rodrigues C, Ribeiro A, Beavogui AH, Lacabaratz C, Thiebaut R, Richert L, Levy Y; Prevac study team. Long-term cellular immunity of vaccines for Zaire Ebola Virus Diseases. Nat Commun. 2024 Sep 3;15(1):7666. doi: 10.1038/s41467-024-51453-z.
- Lee AW, Liu K, Lhomme E, Blie J, McCullough J, Onorato MT, Connor L, Simon JK, Dubey S, VanRheenen S, Deutsch J, Owens A, Morgan A, Welebob C, Hyatt D, Nair S, Hamze B, Guindo O, Sow SO, Beavogui AH, Leigh B, Samai M, Akoo P, Serry-Bangura A, Fleck S, Secka F, Lowe B, Watson-Jones D, Roy C, Hensley LE, Kieh M, Coller BG; PREVAC Study Team. Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVDeltaG-ZEBOV-GP Ebola Vaccine (ERVEBO(R)): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults. Clin Infect Dis. 2024 Apr 10;78(4):870-879. doi: 10.1093/cid/ciad693.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.ZEBOV | Vaccine | 0.5 ml | Intramuscular |
| Subject | Ad26.ZEBOV | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | MVA-BN-Filo | Vaccine | 0.5 ml | Intramuscular |
| Subject | MVA-BN-Filo | Vaccine | 1e+08 unknown | Intramuscular |
| Subject | rVSV boost | Unknown | 1 ml | Intramuscular |
| Subject | rVSV boost | Unknown | 2e+07 unknown | Intramuscular |
| Subject | rVSVΔG-ZEBOV-GP | Vaccine | 1 ml | Intramuscular |
| Subject | rVSVΔG-ZEBOV-GP | Vaccine | 2e+07 unknown | Intramuscular |