Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure

NCT02788227 | Completed Phase 2 FDA Drug

• 2 other identifiers: 16005316-I-0053
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is also no vaccine to prevent infection either before or after exposure. Researchers want to test an Ebola vaccine. They want to give it to people before they are exposed to the virus in order to prevent the disease. Objectives: To see how long-lasting and effective the vaccine rVSV\[delta\]G -ZEBOV-GP (V920) is at preventing Ebola. 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.

Conditions

Healthy Volunteers

Keywords

Ebola Vaccine

Outcome Measures

Primary Outcomes (1)

• Comparison of antibody titer levels between the boosted vs non-boosted groups

  Titer levels in EU/mL

  Month 36

Study Arms (2)

Boosted Group

EXPERIMENTAL

Group randomized at Month 18 to receive booster vaccination

Biological: rVSV-Zebov GP vaccine

Non-boosted Group

EXPERIMENTAL

Group randomized to 'no booster' at Month 18

Biological: rVSV-Zebov GP vaccine

Interventions

rVSV-Zebov GP vaccine BIOLOGICAL

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

Boosted Group; Non-boosted Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age \>=18 years.
• Signed informed consent for the trial.
• At risk of occupational exposure to Ebola virus through laboratory, clinical contact, or field work, in the judgment of the investigator.
• Females of childbearing potential must be willing to use effective methods of contraception, from at least 30 days prior to vaccination through 1 month following vaccination/booster, which would include:
• oral contraceptives, either combined or progestogen alone
• injectable progestogen
• implants of etenogestrel or levonorgestrel
• oestrogenic vaginal ring
• percutaneous contraceptive patches
• intrauterine device or intrauterine system
• committed to abstinence from potentially reproductive sexual contact \[i.e. will NOT engage in heterosexual intercourse where both partners are capable of reproduction\]
• surgical sterilization
• male condom combined with a spermicide
• All males must be willing to use effective methods of contraception for at least 1 month following vaccination/booster, which would include:
• surgical sterilization

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 25830322 BACKGROUND

• 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.

  PMID: 25830326 BACKGROUND

• 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.

  PMID: 39374605 DERIVED

• 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.

  PMID: 36725433 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Susan L Moir, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2016
• First Posted: June 2, 2016
• Study Start: October 14, 2016
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06-18

Locations

US (1)