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Ebola Virus DiseasePhase 2PREVACNCT02876328

Partnership for Research on Ebola VACcinations

A Phase 2 study testing Ad26.ZEBOV, MVA-BN-Filo and rVSVΔG-ZEBOV-GP in people with Ebola Virus Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for
Ebola Virus Disease
What is being tested?
Ad26.ZEBOV, MVA-BN-Filo and rVSVΔG-ZEBOV-GP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,789 participants
Where
6 sitesin 4 countries
Study dates
27 Mar 2017to 20 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • Participants who received the placebo
  • Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
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  • Temporary Exclusion Criteria for Revaccination Post 12 Month Visit:
  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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
  • 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)

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Guinea2 sites

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

    Conakry

  • Landreah

    Conakry

Other trials in Guinea

Mali2 sites

  • Centre pour le Développement des Vaccins (CVD)

    Bamako

  • University Clinical Research Center (UCRC)

    Bamako

Other trials in Mali

Liberia1 site

  • The Redemption Hospital

    Monrovia

Other trials in Liberia

Sierra Leone1 site

  • Mambolo Clinic

    Kapesseh

Other trials in Sierra Leone

About this study

Official title: Partnership for Research on Ebola VACcinations (PREVAC)

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.

Read the detailed description

The purpose of this study is to evaluate the safety and immunogenicity of two Ebola virus disease (EVD) vaccines, Ad26.ZEBOV (rHAd26) and rVSVΔG-ZEBOV-GP (rVSV), in children and adults. These vaccines will be studied using three different strategies: the rHAd26 vaccine plus a MVA-BN-Filo (MVA) boost, and the rVSV vaccine with or without boosting.

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.

Being tested
Ad26.ZEBOV, MVA-BN-Filo, rVSVΔG-ZEBOV-GP, Placebo, rVSV boost
Keywords
Ebola Vaccine
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad26.ZEBOVBiological

    Also called rHAd26

    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-FiloBiological

    Also called MVA, MVA-mBN226B

    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-GPBiological

    Also called rVSV, V920

    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

  • PlaceboBiological

    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 boostBiological

    Also called rVSVΔG-ZEBOV-GP, rVSV, V920

    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

Study groups in NCT02876328
Study groupRoleWhat they receive
Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boostExperimentalParticipants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo
Placebo (0.5 mL)Placebo comparatorParticipants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Receives: Biological: Placebo
rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boostExperimentalParticipants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
Receives: Biological: rVSVΔG-ZEBOV-GP; Biological: Placebo
rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boostExperimentalParticipants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
Receives: Biological: rVSVΔG-ZEBOV-GP; Biological: rVSV boost
Placebo (1 mL)Placebo comparatorParticipants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured through Month 12

Secondary outcomes (2)

  1. Frequency of Serious Adverse Events (SAEs)

    SAEs as defined in the protocol

    Measured: Measured through Month 60

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

    Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.

    Measured: Measured through Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2016 (estimated)
  2. Study start27 Mar 2017
  3. Primary completion24 Dec 2019
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,789 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02876328
Sponsor's protocol ID
C15-33
Other IDs
PREVACEBL3005
Acronym
PREVAC
Status last verified
Jun 2024
First submitted
16 Aug 2016
Last updated
26 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33485369

  • 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.

    PubMed 36516078

  • 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.

    PubMed 42326817

  • 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.

    PubMed 41616038

  • 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.

    PubMed 39559990

  • 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.

    PubMed 39227399

  • 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.

    PubMed 37967326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ad26.ZEBOV, MVA-BN-Filo and rVSVΔG-ZEBOV-GP in people with Ebola Virus Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Guinea, Mali, Liberia, Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response (time frame: Measured through Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02876328, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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