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

NCT02788227 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 16005316-I-0053
• Study Type: interventional
• Target: 248
• Locations: 2 countries
• Sites: 3

Brief 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. 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. 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.

Conditions

Healthy Volunteers

Keywords

Ebola Vaccine

Outcome Measures

Primary Outcomes (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.

  Month 36

Study Arms (3)

Arm 1: Primary Immunization

EXPERIMENTAL

Adults 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.

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

Arm 2a: Post Month 18: Boosted Group

EXPERIMENTAL

Participant 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.

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

Arm 2b: Post Month 18: Non-boosted Group

NO INTERVENTION

Participant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.

Interventions

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.

Arm 1: Primary Immunization; Arm 2a: Post Month 18: Boosted Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 Institutes of Health Clinical Center (CC): lead
• Emory University: collaborator
• Health Canada: collaborator

Study Sites (3)

The Hope Clinic of the Emory Vaccine Center, Emory University

Decatur, Georgia, 30030, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Health Canada, 539 John Buhler Research Center

Winnipeg, Manitoba, R3E 3P4, Canada

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 RESULT

• 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

Results Point of Contact

• Title: Dr. Susan Moir
• Organization: National Institute of Allergy and Infectious Diseases (NIAID)

smoir@nih.gov

301-402-4559

Study Officials

• Susan L Moir, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

• Nadine Rouphael, MD, MSc

  The Hope Clinic of the Emory Vaccine Center, Emory University

  PRINCIPAL INVESTIGATOR

• Guillaume Poliquin, MD, FRCPC

  Health Canada, 539 John Buhler Research Center, Winnipeg, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: June 17, 2026
• Results First Posted: June 17, 2026

Record last verified: 2026-05-18

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)