Partnership for Research on Ebola VACcinations

NCT02876328 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: C15-33PREVACEBL3005
• Study Type: interventional
• Target: 4,789
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Ebola Virus Disease

Keywords

Ebola Vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response

  Antibody responder at 12 months is defined as a participant who experiences a 4-fold increase in antibody level from baseline and for whom the antibody level at 12 months is greater than or equal to 200 EU/mL.

  Measured through Month 12

Secondary Outcomes (2)

• Frequency of Serious Adverse Events (SAEs)

  Measured through Month 60

• Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response

  Measured through Month 60

Study Arms (5)

Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost

EXPERIMENTAL

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo

Placebo (0.5 mL)

PLACEBO COMPARATOR

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Biological: Placebo

rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost

EXPERIMENTAL

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

Biological: rVSVΔG-ZEBOV-GP; Biological: Placebo

rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost

EXPERIMENTAL

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

Biological: rVSVΔG-ZEBOV-GP; Biological: rVSV boost

Placebo (1 mL)

PLACEBO COMPARATOR

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Biological: Placebo

Interventions

Ad26.ZEBOV BIOLOGICAL

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

Also known as: rHAd26

Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost

MVA-BN-Filo BIOLOGICAL

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

Also known as: MVA, MVA-mBN226B

Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost

rVSVΔG-ZEBOV-GP BIOLOGICAL

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

Also known as: rVSV, V920

rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost; rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost

Placebo BIOLOGICAL

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

Placebo (0.5 mL); Placebo (1 mL); rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost

rVSV boost BIOLOGICAL

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

Also known as: rVSVΔG-ZEBOV-GP, rVSV, V920

rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent/assent
• 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

You may not qualify if:

• Fever greater than 38º Celsius
• 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
• Participants who received the placebo
• Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Partnership for Research on Ebola Virus in Liberia (PREVAIL): collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (6)

Centre national de formation et de recherche en santé rurale (Maferyniah)

Conakry, Guinea

Location

Landreah

Conakry, Guinea

Location

The Redemption Hospital

Monrovia, Liberia

Location

Centre pour le Développement des Vaccins (CVD)

Bamako, Mali

Location

University Clinical Research Center (UCRC)

Bamako, Mali

Location

Mambolo Clinic

Kapesseh, Sierra Leone

Location

Related Publications (6)

• 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.

  PMID: 33485369 RESULT

• 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.

  PMID: 36516078 RESULT

• 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. Online ahead of print.

  PMID: 41616038 DERIVED

• 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.

  PMID: 39559990 DERIVED

• 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.

  PMID: 39227399 DERIVED

• 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.

  PMID: 37967326 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Results Point of Contact

• Title: John Tierney, Director of Office of the Clinical Research Policy and Regulatory Operations (OCRPRO)
• Organization: National Institute of Allergy and Infectious Diseases (NIAID)

JTierney@niaid.nih.gov

301.451.5136

Study Officials

• Yazdan Yazdanpannah

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

• Abdoul Habib Beavogui

  Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah

  PRINCIPAL INVESTIGATOR

• Mark Kieh

  Redemption Hospital

  PRINCIPAL INVESTIGATOR

• Bailah Leigh

  University of Sierra Leone

  PRINCIPAL INVESTIGATOR

• Stephen B. Kennedy

  Redemption Hospital

  PRINCIPAL INVESTIGATOR

• Seydou Doumbia

  Universite des Sciences, des Techniques et des Technologies de Bamako

  PRINCIPAL INVESTIGATOR

• Samba O. Sow

  Centre pour le Developpement des Vaccins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 23, 2016
• Study Start: March 27, 2017
• Primary Completion: December 24, 2019
• Study Completion: December 20, 2023
• Last Updated: June 26, 2024
• Results First Posted: September 28, 2022

Record last verified: 2024-06

Locations

LI (1); GU (2); MA (2); SI (1)