Sudan Virus Vaccine for Ebola Virus Disease Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, rVSVΔG-SUDV-GP, to prevent disease caused by the Sudan virus, a type of Ebola virus. Researchers aim to determine if the vaccine is safe and effective in building protection against the virus. Participants will receive either the vaccine or a placebo (a harmless substance with no effect) to compare results. Generally healthy adults willing to follow study guidelines may be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are using corticosteroids, immunosuppressive, anticancer, or other significant medications, you may be excluded if used within the previous 6 months.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the rVSVΔG-SUDV-GP vaccine uses the same technology as the existing Ebola vaccine ERVEBO®, which is already in use. This connection offers some reassurance about its safety. Other vaccines using this technology have proven safe and effective in humans and animals, such as mice and dogs.
While specific human safety data for rVSVΔG-SUDV-GP is not yet available, a similar vaccine, rVSV-EBOV, has been used safely. Participants tolerated it well, experiencing only mild side effects like soreness at the injection site or a mild fever, which are common for vaccines.
As this is a Phase 1 trial, the vaccine is still under safety evaluation. The trial is designed to closely monitor any side effects. Participant health remains the top priority, and they will be observed carefully throughout the trial.12345Why do researchers think this study treatment might be promising?
The rVSVΔG-SUDV-GP vaccine is unique because it uses a live, attenuated virus to stimulate an immune response specifically against the Sudan virus, a strain of the Ebola virus. Unlike current treatments that focus on supportive care and antiviral drugs like remdesivir, this vaccine aims to prevent the disease by equipping the body to fight off the virus before infection can take hold. Researchers are excited about this approach because it represents a proactive measure, potentially offering long-term protection and reducing the likelihood of outbreaks.
What evidence suggests that the rVSVΔG-SUDV-GP vaccine might be an effective treatment for SUDV?
Research has shown that the rVSVΔG-SUDV-GP vaccine, which participants in this trial may receive, uses the same technology as a successful Ebola vaccine. The rVSV-EBOV vaccine, employing a similar method, was 100% effective in preventing Ebola in a past study. This suggests that the rVSVΔG-SUDV-GP vaccine might also be effective against Sudan virus disease. Although specific data for the Sudan virus is limited, the vaccine is designed to trigger a strong immune response. Early animal studies have demonstrated some protection against similar viruses.13456
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 50 who are in good general health. Participants must be willing to use contraception, undergo HIV testing, avoid donating blood or tissues during the study, and follow all study requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the rVSVΔG-SUDV-GP vaccine or placebo in a dose-escalation manner
Safety Monitoring
Participants are monitored for solicited and unsolicited adverse events following vaccination
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
- rVSVΔG-SUDV-GP
Trial Overview
The study is testing a new vaccine called rVSVΔG-SUDV-GP designed to prevent Sudan virus disease (a type of Ebola). Some participants will get the vaccine while others receive a placebo. The main focus is on safety and immune response.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
rVSVΔG-SUDV-GP
Placebo/Diluent
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
Recombinant Sudan virus and evaluation of humoral cross ...
Out of these, rVSV-ΔG-ZEBOV-GP has demonstrated efficacy in the context of an outbreak [11]. Although some cross-protection against SUDV was observed in guinea ...
The rVSV-EBOV vaccine provides limited cross-protection ...
rVSV-EBOV has proven to be a remarkably safe, immunogenic, and effective vaccine, with years of research culminating in its recent licensure ( ...
rVSVΔG-ZEBOV-GP Vaccine Is Highly Immunogenic ... - PMC
A pivotal Phase 3 study conducted in Guinea using a ring vaccination protocol demonstrated 100% efficacy in individuals ≥10 days after receiving ...
Sudan Virus Vaccines
Vesicular stomatitis virus-based Ebola vaccines with improved cross-protective efficacy. 38, 24, Viral Vector, rVSVΔG-SUDV-GP. A monovalent vaccine which ...
Sudan virus disease – A quick review
... Filovirus diseases. Unlike Ebola virus disease, no effective antiviral and vaccine is available for SVD. The outbreak was declared over after 115 days, with ...
NCT07565090 | A Clinical Study to Investigate the Safety ...
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease ...
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