Ebola Vaccine for Occupational Exposure Prevention

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, others

Disqualifiers: Active malignancy, Autoimmune disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a vaccine called rVSV[delta]G ZEBOV-GP (V920) designed to prevent Ebola. It targets healthy adults who might be exposed to Ebola at work. The vaccine uses a harmless virus that includes a part of the Ebola virus to help the body learn to fight it. Participants will be monitored over an extended period to see how well the vaccine works and how long its effects last. The rVSVΔG-ZEBOV-GP (V920) vaccine was approved by the FDA in December 2019 for the prevention of Ebola virus disease caused by Zaire ebolavirus.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your medication might affect the immune response or interfere with the study, the investigator may advise changes. It's best to discuss your specific medications with the trial team.

Is the rVSVΔG-ZEBOV-GP Ebola vaccine safe for humans?

The rVSVΔG-ZEBOV-GP Ebola vaccine has been shown to be generally safe in humans, with studies indicating low risk of person-to-person infection and low pathogenicity (ability to cause disease). It has been approved by major health agencies like the European Medicines Agency and the U.S. Food and Drug Administration, and safety data from trials show only infrequent, low-level side effects. ^{1 2 3 4 5}

What makes the Ebola vaccine rVSV[Delta]G-ZEBOV-GP unique compared to other treatments?

The Ebola vaccine rVSV[Delta]G-ZEBOV-GP is unique because it is specifically designed for occupational exposure prevention, using a live attenuated (weakened) virus to stimulate an immune response without causing the disease, which is different from traditional treatments that focus on managing symptoms after infection. ^{6 7 8 9 10}

Research Team

Richard T Davey, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

Healthy adults over 18 at risk of Ebola exposure through work, willing to minimize blood and body fluid contact with others for 14 days post-vaccination. They must agree not to take other investigational drugs or donate blood for a year after vaccination, use effective contraception methods, and be non-pregnant and non-breastfeeding.

Inclusion Criteria

Signed informed consent for the trial.

Signed informed consent for the trial

You agree not to have sexual intercourse that could result in pregnancy during the study.

Exclusion Criteria

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-Barr(SqrRoot)(Copyright) 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 vaccination (Day0)/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)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Vaccination

Participants receive a single dose of the rVSVdeltaG-ZEBOV-GP vaccine

1 day

1 visit (in-person)

Monitoring

Participants are monitored for adverse events and immune response at specified intervals

36 months

Visits at 1, 3, 6, 12, 18, 19, 24, 30, and 36 months

Booster Vaccination

Participants randomized to receive a booster dose at month 18

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• rVSV[Delta]G-ZEBOV-GP

Trial Overview The trial is testing the rVSV-Zebov GP vaccine's long-term effectiveness in preventing Ebola when given before exposure. Participants will receive an initial shot followed by monitoring visits over 36 months; half will get a booster dose at month 18.

Participant Groups

Group I: Non-boosted Group Experimental Treatment 1 Intervention

Group randomized to 'no booster' at Month 18

Group II: Boosted Group Experimental Treatment 1 Intervention

Group randomized at Month 18 to receive booster vaccination

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Findings from Research

The rVSVΔG-ZEBOV-GP vaccine was generally well-tolerated in a study of 1197 participants, with increased rates of mild to moderate adverse events (AEs) like fever and joint pain compared to placebo, but no serious vaccine-related adverse events or deaths were reported.

Fever was observed in 20.2% of the combined lots group and 32.2% of the high-dose group, indicating that while the vaccine can cause some side effects, it is considered safe for individuals at risk for Ebola virus disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. Halperin, SA., Arribas, JR., Rupp, R., et al.[2018]

The rVSV∆G-ZEBOV-GP vaccine was found to be well tolerated among 513 healthy adults, with most adverse events being mild to moderate and occurring shortly after vaccination, particularly at higher doses.

The vaccine induced a strong immune response, with 95.7% of participants showing seroconversion and sustained antibody levels for up to one year, supporting the use of the 2×10^7 PFU dose for effective protection against Ebola.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. Heppner, DG., Kemp, TL., Martin, BK., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: A phase I randomised trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Lessons Learned from the Development and Roll-Out of the rVSVΔG-ZEBOV-GP Zaire ebolavirus Vaccine to Inform Marburg Virus and Sudan ebolavirus Vaccines. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Environmental Risk Assessment for rVSVΔG-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Protective immunity against alpha-cobratoxin following a single administration of a genetic vaccine encoding a non-toxic cobratoxin variant. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Effective equine immunization protocol for production of potent poly-specific antisera against Calloselasma rhodostoma, Cryptelytrops albolabris and Daboia siamensis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Early Experience with Crotalidae Immune F(ab')2 Antivenom to Treat Arizona Rattlesnake Envenomations. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Trial of Russell's Viper Venoid. II. Human immunization with venoid. Burma, DMR Working Group on Clinical Trial of Russell's Viper Venoid. [2019]

10. Thailand pubmed.ncbi.nlm.nih.gov

The efficacy of compression immobilization technique in retarding spread of radio-labeled Russell's viper venom in rhesus monkeys and 'mock venom' NaI131 in human volunteers. [2013]