Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health

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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new Ebola vaccine in healthy adults to see if it is safe and effective. The vaccine uses a modified virus to help the immune system learn to fight Ebola. Participants will receive different doses and be monitored for several months. The Ad26.ZEBOV and MVA-BN-Filo vaccines have been previously tested and shown to be safe and effective in various populations, including children and adults in Africa.

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.

What data supports the effectiveness of the rVSVΔG-SEBOV-GP Vaccine treatment?

The rVSVΔG-ZEBOV-GP vaccine, which is similar to the rVSVΔG-SEBOV-GP vaccine, has been shown to prevent Ebola virus disease effectively in clinical trials. This suggests that the rVSV-based platform used in these vaccines can be effective in preventing viral diseases. ^{1 2 3 4 5}

Is the rVSVΔG-SEBOV-GP Vaccine safe for humans?

The rVSVΔG-ZEBOV-GP vaccine, similar to the rVSVΔG-SEBOV-GP Vaccine, has been shown to be generally safe in humans, with only low-level shedding and transient viremia (temporary presence of the virus in the blood). Some people may experience temporary side effects like headaches or joint pain, but the overall risk of serious harm is low. ^{1 2 3 6 7}

How is the rVSVΔG-SEBOV-GP Vaccine different from other Ebola treatments?

The rVSVΔG-SEBOV-GP Vaccine is unique because it is a live, genetically modified vaccine that uses a vesicular stomatitis virus to deliver Ebola virus proteins, which helps the body build immunity. Unlike other treatments, it is designed to be a single-dose vaccine, making it potentially more convenient and faster to administer during outbreaks. ^{1 2 3 8 9}

Eligibility Criteria

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

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)

Treatment Details

Interventions

• rVSVΔG-SEBOV-GP Vaccine

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. United States 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. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis. [2021]

5. England 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!). [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Baseline gene signatures of reactogenicity to Ebola vaccination: a machine learning approach across multiple cohorts. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Controlled viral glycoprotein expression as a safety feature in a bivalent rabies-ebola vaccine. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of rVSVΔG-ZEBOV-GP glycoproteins using automated capillary western blotting. [2021]

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

Vesicular stomatitis virus-based vaccines protect nonhuman primates against Bundibugyo ebolavirus. [2021]