rVSVΔG-SEBOV-GP Vaccine for Ebola

No longer recruiting at 1 trial location

Overseen By Dagna Laufer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: International AIDS Vaccine Initiative

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Pregnancy, Bleeding disorder, Infectious disease, Malignancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new vaccine, rVSVΔG-SEBOV-GP, designed to protect against the Sudan Ebola virus. Researchers will administer the vaccine at three different dose levels to observe the body's response and identify any side effects. The trial suits adults in generally good health who are willing to follow study rules and have not received recent vaccines or have certain medical conditions. Participants must agree to regular health checks and use effective contraception during the trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new vaccine.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a serious infection requiring treatment or have received certain vaccines or blood products recently, you may not be eligible to participate.

Is there any evidence suggesting that the rVSVΔG-SEBOV-GP Vaccine is likely to be safe for humans?

Research shows that the rVSVΔG-SEBOV-GP vaccine is generally well-tolerated. Studies on similar vaccines, such as the rVSVΔG-ZEBOV-GP, have found no serious side effects directly caused by the vaccine. Some participants experienced more reactions at the injection site and mild symptoms compared to those who received a placebo, but these were not serious. The vaccine is currently in a Phase 1 trial, focusing on testing its safety at different dose levels. Safety data from similar vaccines and this phase suggest that the vaccine is expected to be safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for Ebola virus disease focus on supportive care, like rehydration and managing symptoms, or using antiviral medications. Unlike these existing options, the rVSVΔG-SEBOV-GP vaccine is a preventive measure designed to stimulate the immune system to fight off the virus before infection occurs. Researchers are excited about this vaccine because it uses a recombinant vesicular stomatitis virus (rVSV) as a vector to deliver the Ebola glycoprotein, which is a novel approach to inducing a strong immune response. This method could potentially offer a more robust and long-lasting protection compared to current treatments.

What evidence suggests that the rVSVΔG-SEBOV-GP Vaccine might be an effective treatment for Ebola?

Research shows that the rVSVΔG-SEBOV-GP vaccine, which participants in this trial may receive, could be effective against Ebola virus disease. Similar vaccines, such as the rVSVΔG-ZEBOV-GP, have demonstrated 98% effectiveness in protecting against Ebola in past studies. This vaccine helps the body produce antibodies, which are part of the immune system's defense against the virus. Experts recommend these vaccines for adults who might be exposed to Ebola. Although specific data on the rVSVΔG-SEBOV-GP vaccine is still being gathered, early results from similar vaccines are encouraging. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

As applicable undergo urine pregnancy tests

Good general health

Use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine

Exclusion Criteria

Bleeding disorder

Infectious disease

Prior exposure to SEBOV or history of any hemorrhagic fever

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of the rVSVΔG-SEBOV-GP Vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity for 6 months after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• rVSVΔG-SEBOV-GP Vaccine

How Is the Trial Designed?

Group I: Study Group 3 Experimental Treatment 1 Intervention

rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^8 pfu intramuscularly Day 1

Group II: Study Group 2 Experimental Treatment 1 Intervention

rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^7 pfu intramuscularly Day 1

Group III: Study Group 1 Experimental Treatment 1 Intervention

rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10\^6 pfu intramuscularly Day 1

Who Is Running the Clinical Trial?

International AIDS Vaccine Initiative

Lead Sponsor

Trials

52

Recruited

13,300+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Published Research Related to This Trial

The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) effectively induced strong antibody responses in both children and adults after a single dose, with responses in children being non-inferior to those in adults, based on a study involving 1,602 participants.

Vaccine virus shedding was observed in 31.7% of vaccinated children but was time-limited, peaking by Day 7 and not occurring after Day 28 post-first dose, indicating a favorable safety profile for the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and vaccine shedding after 1 or 2 doses of rVZVΔG-ZEBOV-GP Ebola vaccine (ERVEBO®): Results from a phase 2, randomized, placebo-controlled trial in children and adults. Lee, AW., Liu, K., Lhomme, E., et al.[2023]

The rVSV-ZEBOV vaccine demonstrated 100% efficacy in preventing Ebola virus disease among vaccinated individuals, with no cases occurring 10 days or more after vaccination in both randomized and non-randomized clusters.

Out of 5837 individuals vaccinated, most reported mild adverse events, with only three serious adverse events linked to the vaccine, all of which resolved without lasting effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!). Henao-Restrepo, AM., Camacho, A., Longini, IM., et al.[2022]

Citations

1.

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/?term=40143273

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 robust antibody ...

3.

cdc.gov

cdc.gov/acip/evidence-to-recommendations/ebola-vaccine-etr.html

Evidence to Recommendations for rVSVΔG-ZEBOV-GP ...

Pre-exposure vaccination with rVSVΔG-ZEBOV-GP vaccine is recommended for adults 18 years of age or older in the United States population who are at potential ...

4.

cdc.gov

cdc.gov/acip/grade/ebola-vaccine.html

GRADE: rVSVΔG-ZEBOV-GP Ebola vaccine for persons in ...

Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05724472

Study Details | NCT05724472 | Evaluation of Safety and ...

This is a single-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of rVSVΔG-SEBOV-GP vaccine at 3 dose ...

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28549145/

Six-Month Safety Data of Recombinant Vesicular Stomatitis ...

rVSVΔG-ZEBOV-GP was generally well-tolerated, with increased rates of injection-site and systemic AEs compared to placebo, and no vaccine-related SAEs or ...

8.

who.int

who.int/groups/global-advisory-committee-on-vaccine-safety/topics/ebola-virus-vaccines

Ebola virus vaccines

... safety data suggest that the vaccine is well tolerated by adults and children. ... Phase 1 studies of the rVSV-ZEBOV-GP vaccine began in October 2014 with limited ...