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Healthy VolunteersPhase 2NCT02788227

Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine)

A Phase 2 study testing rVSV∆G-ZEBOV-GP Vaccine (V920) in people with Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 3 sites in 2 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

Background: The Ebola virus causes a severe disease that can be fatal. The usual incubation period to illness after being exposed is 2 to 21 days. There are only limited treatments currently available for Ebola infection. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
rVSV∆G-ZEBOV-GP Vaccine (V920)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
3 sitesin 2 countries
Study dates
14 Oct 2016to 17 Jun 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Any condition that would limit the ability of the participant to meet protocol requirements or would place the participant at unreasonable risk. Examples include:
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health, per the investigator. A clinically significant condition or process includes but is not limited to:
  • A process that would adversely affect the systemic immune response
  • A process that would require medication that might adversely affect the systemic immune response
  • Any contraindication to repeated injections or blood draws
  • A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period
Show all 23Show fewer
  • A condition or process for which signs or symptoms could be confused with reactions to vaccine
  • Presence of any pre-existing illness or clinical history that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study. This includes but is not limited to:
  • Active malignancy
  • History of Guillain-Barre Syndrome
  • History of neurological disorder that may increase risk (history of encephalitis, stroke, or seizure)
  • Active autoimmune disorder requiring systemic immunosuppressive treatment
  • Any concomitant medication for which reported side effects or adverse events, in the judgment of the investigator, may interfere with assessment of safety.
  • Subjects who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol.
  • Pregnant or breast feeding (must have negative serum or urine pregnancy test on the day of vaccination, prior to vaccination)
  • Known allergy to the components of the rVSV∆G-ZEBOV-GP vaccine (V920) vaccine product (VSV, albumin, tris).
  • History of severe local or systemic reactions to any vaccination.
  • Received an investigational drug within 5 half-lives or 30 days, whichever is longer, prior to vaccination (Day 0)/booster (month 18).
  • Received killed vaccines 14 days before, or intention to receive within 7 days following, vaccination (Day 0)/booster (month 18).
  • Received live virus vaccines within 30 days before, or intention to receive live virus vaccines within 30 days following, vaccination (Day 0)/booster (month 18).
  • Received immunoglobulins and/or any blood products within the 120 days preceding vaccination (Day 0)/booster (month 18).
  • Received allergy treatment with antigen injections within 30 days before vaccination (Day 0)/booster (month 18).
  • Clinical evidence (e.g. oral temp >38 degrees Celsius, systemic symptoms) of a systemic infection or other acute intercurrent illness at the proposed time of vaccination (Day 0)/booster (month 18).

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

  • The Hope Clinic of the Emory Vaccine Center, Emory University

    Decatur, Georgia, 30030

Other trials in United States

Canada1 site
  • Health Canada, 539 John Buhler Research Center

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

Official title: A Multicenter Study of the Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine) for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebola Virus Exposure (PREPARE)

Background:

The Ebola virus causes a severe disease that can be fatal. The usual incubation period to illness after being exposed is 2 to 21 days. There are only limited treatments currently available for Ebola infection. A vaccine to prevent infection either before or after exposure was approved in 2020 but the durability of the vaccine response is unknown. Researchers wish to study the potential to increase the antibody response to the licensed Ebola vaccine. An improved response before exposure to the virus potentially could increase the vaccine's effectiveness in preventing disease.

Read more

Objectives:

To see if the antibody response to the vaccine, rVSV∆G-ZEBOV-GP vaccine (V920), could potentially be improved by providing a booster injection several months after the primary immunization.

Eligibility:

Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical contact.

Design:

  • Participants will be screened with medical history, physical exam, and blood tests.
  • Participants will get the study vaccine. It will be injected into their upper arm.
  • Participants will be monitored closely for at least 30 minutes. They will get a diary card to record any symptoms they have from the vaccine for up to 14 days.
  • Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36 months.
  • Eighteen months after they join the study, participants will be randomly assigned to one of two groups. One group will get a second (or booster) dose of the vaccine. The other group will not get a second dose.
  • This study lasts 36 months.

In December 2024, the study was approved to re-enroll up to 30 participants from the primary cohort to check longer-term immune response to the study vaccine beyond 36 months.

Read the detailed description

Between 1994 and the present, there have been multiple Ebola virus outbreaks affecting mostly central Africa. However, the 2014/2015 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected, and in disruption of typical activities of civil society.

This protocol is a multi-center study to evaluate the durability of the immune response following the open label administration of the rVSV∆G-ZEBOV-GP vaccine (V920) as pre-exposure prophylaxis for adults who have an occupational risk for potential exposure to Ebola virus. The vaccine uses a live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (rVSV∆G-ZEBOV-GP vaccine also known as V920).

All subjects will receive a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) (>=7.2 x 10^7 pfu) on Day 0. We will collect adverse events after vaccination and at month 1 and month 19, serious adverse events (SAE) for the duration of the study, and assess the immune response at months 1, 3, 6, 12, 18, 19, 24, 30, and 36.

A single booster immunization with the same dose of study vaccine as the primary dose (>=7.2 x 10^7 pfu/mL) will be given to those randomized at month 18 to the booster arm of the trial. However, if at any time during the observation period antibody levels fall below a predefined seroprotective threshold (yet to be defined in parallel or newly planned studies), a booster will be offered to those who have not previously received a booster injection.

Being tested
rVSV∆G-ZEBOV-GP Vaccine (V920)
Keywords
Ebola Vaccine

What participants receive

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

  • rVSV∆G-ZEBOV-GP Vaccine (V920)Biological

    Primary vaccination for all participants, one-to-one randomization at Month 18 to receive booster vaccination or no booster.

Study groups in NCT02788227
Study groupRoleWhat they receive
Arm 1: Primary ImmunizationExperimentalAdults deemed to be at current or future occupational risk (laboratory, clinical, or field) for exposure to Ebola virus received a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle at the time of enrollment.
Receives: Biological: rVSV∆G-ZEBOV-GP Vaccine (V920)
Arm 2a: Post Month 18: Boosted GroupExperimentalParticipant were randomized at 18 months post primary immunization to receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle.
Receives: Biological: rVSV∆G-ZEBOV-GP Vaccine (V920)
Arm 2b: Post Month 18: Non-boosted GroupNo interventionParticipant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.

What is being measured

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

  1. Geometric Mean Antibody Titres

    The geometric mean antibody titres (GMT) was measured by Filovirus Animal Nonclinical Group ELISA at month 36 months for the randomized study cohort.

    Measured: Month 36

Timeline

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

  1. First posted2 Jun 2016 (estimated)
  2. Study start14 Oct 2016
  3. Primary completion17 Jun 2025
  4. Study completion17 Jun 2025

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
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02788227
Sponsor's protocol ID
160053
Other IDs
16-I-0053
Status last verified
18 May 2026
First submitted
28 May 2016
Last updated
17 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Hu Z, Munoz P, Moon JE, Ruck RC, Bennett JW, Twomey PS, Gutierrez RL, Remich SA, Hack HR, Wisniewski ML, Josleyn MD, Kwilas SA, Van Deusen N, Mbaya OT, Zhou Y, Stanley DA, Jing W, Smith KS, Shi M, Ledgerwood JE, Graham BS, Sullivan NJ, Jagodzinski LL, Peel SA, Alimonti JB, Hooper JW, Silvera PM, Martin BK, Monath TP, Ramsey WJ, Link CJ, Lane HC, Michael NL, Davey RT Jr, Thomas SJ; rVSVDeltaG-ZEBOV-GP Study Group. A Recombinant Vesicular Stomatitis Virus Ebola Vaccine. N Engl J Med. 2017 Jan 26;376(4):330-341. doi: 10.1056/NEJMoa1414216. Epub 2015 Apr 1.

    PubMed 25830322
  • Agnandji ST, Huttner A, Zinser ME, Njuguna P, Dahlke C, Fernandes JF, Yerly S, Dayer JA, Kraehling V, Kasonta R, Adegnika AA, Altfeld M, Auderset F, Bache EB, Biedenkopf N, Borregaard S, Brosnahan JS, Burrow R, Combescure C, Desmeules J, Eickmann M, Fehling SK, Finckh A, Goncalves AR, Grobusch MP, Hooper J, Jambrecina A, Kabwende AL, Kaya G, Kimani D, Lell B, Lemaitre B, Lohse AW, Massinga-Loembe M, Matthey A, Mordmuller B, Nolting A, Ogwang C, Ramharter M, Schmidt-Chanasit J, Schmiedel S, Silvera P, Stahl FR, Staines HM, Strecker T, Stubbe HC, Tsofa B, Zaki S, Fast P, Moorthy V, Kaiser L, Krishna S, Becker S, Kieny MP, Bejon P, Kremsner PG, Addo MM, Siegrist CA. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe. N Engl J Med. 2016 Apr 28;374(17):1647-60. doi: 10.1056/NEJMoa1502924. Epub 2015 Apr 1.

    PubMed 25830326
  • Davey RT Jr, Collins GL, Rouphael N, Poliquin G, McConnell R, Grubbs G, Moir SL, Langley JM, Teitelbaum M, Hewlett AL, McLellan SLF, Bhadelia N, Raabe VN, Mulligan MJ, Maljkovic Berry I, Dighero-Kemp B, Kurtz JR, Hensley LE, Dozier NCE, Marron LCB, DuChene A, Kuhn JH, Brown SK, Khurana S, Lane HC, Neaton JD. Safety and immunogenicity of a delayed booster dose of the rVSVDeltaG-ZEBOV-GP vaccine for prevention of Ebola virus disease: a multicentre, open-label, phase 2 randomised controlled trial. Lancet Microbe. 2024 Nov;5(11):100923. doi: 10.1016/S2666-5247(24)00163-0. Epub 2024 Oct 4.

    PubMed 39374605
  • Raabe V, Lai L, Morales J, Xu Y, Rouphael N, Davey RT, Mulligan MJ. Cellular and humoral immunity to Ebola Zaire glycoprotein and viral vector proteins following immunization with recombinant vesicular stomatitis virus-based Ebola vaccine (rVSVDeltaG-ZEBOV-GP). Vaccine. 2023 Feb 17;41(8):1513-1523. doi: 10.1016/j.vaccine.2023.01.059. Epub 2023 Jan 31.

    PubMed 36725433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rVSV∆G-ZEBOV-GP Vaccine (V920) in people with Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 3 sites in 2 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 0 inclusion and 23 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. 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. 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 17 Jun 2026). 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?

Geometric Mean Antibody Titres (time frame: Month 36). 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 NCT02788227, which also lists 4 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 17 Jun 2026.

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