rVSV∆G-MARV-GP Vaccine for Marburg Virus Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine called rVSV∆G-MARV-GP, designed to protect against Marburg Virus Disease—a severe illness similar to Ebola. The main goal is to determine if the vaccine is safe and if it prompts an immune response (how the body fights off germs) in healthy adults. Participants will receive either the actual vaccine or a placebo (a harmless substance used for comparison). This trial suits adults who are generally healthy and have not been exposed to the Marburg Virus or taken certain vaccines before. 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 have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but it excludes those who have used corticosteroids, immunosuppressive, anticancer, or other significant medications in the past 6 months. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that the rVSV∆G-MARV-GP vaccine is likely to be safe for humans?
Research has shown that the rVSV∆G-MARV-GP vaccine appears promising in early studies. One study tested the vaccine on animals like monkeys, and it protected them from the Marburg virus without causing harm. This suggests potential safety for humans as well.
Early tests with healthy adults assessed the vaccine's safety and its ability to trigger an immune response. The results have been encouraging, with no serious side effects reported.
It's important to remember that this vaccine remains in the early stages of human testing. Much remains to be learned about its safety. However, the initial findings are positive, indicating the vaccine might be safe and effective.12345Why do researchers think this study treatment might be promising?
Unlike other treatments for Marburg virus disease, the rVSV∆G-MARV-GP vaccine is unique because it uses a live attenuated vesicular stomatitis virus (VSV) that’s engineered to include a protein from the Marburg virus. This new mechanism prompts the immune system to recognize and fight the actual Marburg virus if encountered. Researchers are excited about this approach as it represents a novel way to potentially offer strong, lasting immunity against a virus that currently has no approved vaccine.
What evidence suggests that the rVSV∆G-MARV-GP vaccine might be an effective treatment for Marburg Virus Disease?
Studies have shown that the rVSV∆G-MARV-GP vaccine, which participants in this trial may receive, provides strong protection against the Marburg virus in animals such as guinea pigs and monkeys. In these studies, vaccinated animals were completely protected from the virus. Research indicates that this vaccine can rapidly boost the immune system, offering protection within just a week after a single dose. This swift and lasting protection makes it a promising option for preventing Marburg virus disease.13467
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 50 who are willing to follow study rules, avoid donating blood or tissues during the study, use condoms and contraception if sexually active, undergo HIV testing, and be available for follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-escalation Treatment
Participants receive one of four escalating doses of the rVSV∆G-MARV-GP vaccine or placebo, with safety assessments conducted after each dose level
Safety Assessment
Safety and tolerability of the vaccine are assessed, including unsolicited and solicited reactogenicity and adverse events
Follow-up
Participants are monitored for safety and immunogenicity, including antibody responses, up to 6 months after immunization
What Are the Treatments Tested in This Trial?
Interventions
- rVSV∆G-MARV-GP
Trial Overview
The study is testing different doses of a new Marburg virus vaccine (rVSV∆G-MARV-GP) compared to a placebo. Participants are randomly assigned by chance and neither they nor some researchers know which group they're in.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
International AIDS Vaccine Initiative
Lead Sponsor
Biomedical Advanced Research and Development Authority
Collaborator
Citations
Therapeutic advances in Marburg virus disease - PMC - NIH
This work explored ongoing studies on the recent vaccine developments and experimental therapies, such as a recombinant vesicular stomatitis virus (VSV)-based ...
IAVI begins first-in-human Phase 1 trial of single-dose ...
... rVSV∆G-MARV-GP vaccine candidate. In nonclinical studies, the vaccine candidate has generated consistently strong efficacy results. A ...
NCT06265012 | Study to Evaluate the Recombinant VSV ...
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP [Angola]
Strengthening global health resilience: Marburg virus-like ...
Recent data from Phase III clinical trials have provided compelling evidence of the effectiveness of Marburg VLP vaccines in real-world settings. Large-scale ...
Efficacy and Immunogenicity of a Recombinant Vesicular ...
These results indicate rVSV-MARV has the potential to be an effective prophylactic vaccine against MHF and, following successful IND ...
Marburg Marburgvirus - Pathogen Safety Data Sheets
The candidate vaccines are recombinant vesicular stomatitis virus-based vector encoding MARV GP (rVSVΔG-MARV-GP), which were evaluated in rhesus monkeys ...
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ctv.veeva.com
ctv.veeva.com/study/study-to-evaluate-safety-and-immunogenicity-of-rvsv-marburg-virus-vaccine-candidate-phv01-in-healthyMarburg Virus Vaccine Candidate (PHV01) in Healthy Adult ...
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of ...
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