Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
4789 participants
INTERVENTIONAL
2017-03-27
2023-12-20
Brief Summary
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Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
NCT02509494
ZEBOVAC (Ebola Vaccine Trial, Ad26.ZEBOV/MVA-BN-Filo)
NCT04028349
A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo
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Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
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EBOVAC-Salone Extension
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Detailed Description
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Participants will be randomized into five groups: the Ad26.ZEBOV vaccine with an MVA boost, the rVSV vaccine with or without boosting, or one of two placebo groups. At Day 0 (study entry), participants will receive the Ad26.ZEBOV vaccine, the rVSV vaccine, or placebo.
At Day 56, participants assigned to the rVSV vaccine without a boost and the two placebo groups will receive placebo. Those initially given the Ad26.ZEBOV vaccine will receive the MVA boost. Those assigned to the boosted rVSV group will receive the rVSV boost.
Additional study visits will occur on Days 7, 14, 28, and 63, and at Months 3, 6, 12, 24, 36, 48, and 60. Study visits may include blood collection and other assessments.
Some participants may take part in substudies, which will include blood or saliva collection.
After the Month 12 visit, during the long-term follow-up, the participants who received the placebo will be vaccinated with a single dose of rVSVΔG-ZEBOV-GP vaccine in Liberia and Mali and with the Ad26.ZEBOV/MVA-BN-Filo vaccine strategy in Guinea and Sierra Leone. The participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy will be offered a single dose of the Ad26.ZEBOV or MVA-BN-Filo vaccine in Guinea and Sierra Leone and a single dose of rVSVΔG-ZEBOV-GP in Liberia and Mali.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV
0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
MVA-BN-Filo
0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Placebo (0.5 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo
0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP
1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Placebo
0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP
1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSV boost
1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Placebo (1 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo
0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Interventions
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Ad26.ZEBOV
0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
MVA-BN-Filo
0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSVΔG-ZEBOV-GP
1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Placebo
0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
rVSV boost
1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 1 year
* Planned residency in the area of the study site for the next 12 months
* Willingness to comply with the protocol requirements
* Participants who received the placebo
* Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
Exclusion Criteria
* History of EVD (self-report)
* Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
* Positive HIV test for participants less than 18 years of age
* Reported current breast-feeding
* Prior vaccination against Ebola (self-report)
* Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
* In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol
* Fever greater than 38º Celsius
* Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
* Reported current breast-feeding (self-report)
* Any vaccination in the past 28 days or planned within the 28 days after trial vaccination
* EVD notified in the electronic case report form
* For minor participants: change in HIV status since enrollment (self-report)
* Previous Ebola vaccination outside of the study including incomplete vaccine strategies
* Known medical history or significant risk factors for a thrombotic and/or thrombocytopenic event (for participants who will receive the Ad26.ZEBOV or MVA-BN-Filo vaccine)
1 Year
ALL
Yes
Sponsors
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Partnership for Research on Ebola Virus in Liberia (PREVAIL)
NETWORK
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
London School of Hygiene and Tropical Medicine
OTHER
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Yazdan Yazdanpannah
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Abdoul Habib Beavogui
Role: PRINCIPAL_INVESTIGATOR
Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah
Mark Kieh
Role: PRINCIPAL_INVESTIGATOR
Redemption Hospital
Bailah Leigh
Role: PRINCIPAL_INVESTIGATOR
University of Sierra Leone
Stephen B. Kennedy
Role: PRINCIPAL_INVESTIGATOR
Redemption Hospital
Seydou Doumbia
Role: PRINCIPAL_INVESTIGATOR
Universite des Sciences, des Techniques et des Technologies de Bamako
Samba O. Sow
Role: PRINCIPAL_INVESTIGATOR
Centre pour le Developpement des Vaccins
Locations
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Centre national de formation et de recherche en santé rurale (Maferyniah)
Conakry, , Guinea
Landreah
Conakry, , Guinea
The Redemption Hospital
Monrovia, , Liberia
Centre pour le Développement des Vaccins (CVD)
Bamako, , Mali
University Clinical Research Center (UCRC)
Bamako, , Mali
Mambolo Clinic
Kapesseh, , Sierra Leone
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PREVACEBL3005
Identifier Type: OTHER
Identifier Source: secondary_id
C15-33
Identifier Type: -
Identifier Source: org_study_id
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