Ebola Vaccine for Occupational Exposure Prevention

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a vaccine designed to prevent Ebola, a severe and often deadly disease. The focus is on evaluating the vaccine's effectiveness and duration in preventing Ebola before exposure. Participants will be split into two groups: one will receive a booster dose of the vaccine, and the other will not. Ideal candidates are healthy adults who might encounter the Ebola virus at work, such as those in labs or clinical settings. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the rVSVΔG-ZEBOV-GP Ebola vaccine is generally safe for people. One study found no serious side effects linked to the vaccine, indicating it is well-tolerated. Participants demonstrated a good immune response, meaning the vaccine prepared their bodies to fight Ebola if needed. Another study found that just one dose effectively prevented Ebola in those at risk. While some mild side effects like tiredness or a sore arm might occur, the vaccine has maintained a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for Ebola?

Researchers are excited about the rVSV[Delta]G-ZEBOV-GP vaccine because it uses a live, attenuated virus to trigger a strong immune response against the Ebola virus. Most current vaccines for Ebola, like those utilizing recombinant viral vectors, require multiple doses or complex administration schedules. This new vaccine is distinctive because it potentially offers robust protection with fewer doses, thanks to its unique mechanism of using a genetically engineered vesicular stomatitis virus. Additionally, the study explores the effects of a booster shot, aiming to enhance long-term immunity, which could be a game-changer in preventing occupational exposure to Ebola.

What evidence suggests that this vaccine might be an effective treatment for Ebola?

Studies have shown that the rVSV[Delta]G-ZEBOV-GP vaccine effectively prevents Ebola. Earlier research found that the vaccine provided 84% protection against Ebola virus disease starting 10 days after vaccination. This means about 84 out of every 100 vaccinated individuals were protected from the disease. Another study demonstrated that a single dose of this vaccine offered 98% protection in a controlled setting. In this trial, participants will be divided into two groups: the Boosted Group, receiving a booster vaccination at Month 18, and the Non-boosted Group, which will not receive a booster. The vaccine helps the body's immune system recognize and fight the Ebola virus, offering strong protection against future exposure. These promising results suggest that the vaccine could be a powerful tool in preventing Ebola for those at risk. ^{1 2 4 6 7}

Who Is on the Research Team?

Susan L Moir, Ph.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(24)00419-5/fulltext

Effectiveness of rVSV-ZEBOV vaccination during the 2018– ... 10 days or more after vaccination, the effectiveness of rVSV-ZEBOV against Ebola virus disease was estimated to be 84% (95% credible interval 70 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39178866/

Effectiveness of rVSV-ZEBOV vaccination during the 2018- ... 10 days or more after vaccination, the effectiveness of rVSV-ZEBOV against Ebola virus disease was estimated to be 84% (95% credible interval 70 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02788227

Study Details | NCT02788227 | Immunogenicity of ... This protocol is a multi-center study to evaluate the durability of the immune response following the open label administration of the rVSVdeltaG-ZEBOV-GP ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0163445324001713

Replication, safety and immunogenicity of the vectored ... Children experienced stronger and longer vector replication in plasma and shedding in saliva following rVSVΔG-ZEBOV-GP vaccination.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11945660/

rVSVΔG-ZEBOV-GP Vaccine Is Highly Immunogenic and ... A single vaccination conferred 98% protection from lethal intramuscular EBOV challenge across all dose groups. These results demonstrate that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5853326/

Six-Month Safety Data of Recombinant Vesicular Stomatitis ... There were no vaccine-related SAEs observed. The study supports the use of the rVSVΔG-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Supplementary ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6816421/

Recombinant vesicular stomatitis virus vector vaccines for ... Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo ...