Marburg Vaccine for Marburg Virus Disease

Not currently recruiting at 6 trial locations
NW
AG
NW
Overseen ByNorm Waters, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine for the Marburg virus, a serious disease similar to Ebola. The goal is to assess the vaccine's safety and its ability to trigger an immune response in healthy adults. Participants will receive either the actual cAd3-Marburg vaccine or a placebo (inactive substance) for comparison. The trial seeks healthy adults who have not had the Marburg virus, do not have significant existing health issues, and agree to avoid other vaccines for a specified period. 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, certain medications like systemic corticosteroids in high doses, anticoagulants, and some investigational drugs are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that the cAd3-Marburg vaccine is likely to be safe for humans?

Research has shown that the cAd3-Marburg vaccine is safe for people. Studies found that most participants did not experience serious side effects, with 93% handling the vaccine well. Another study reported no safety problems during a 48-week follow-up. Although no vaccine for the Marburg virus has been approved yet, early research on the cAd3-Marburg vaccine's safety appears promising.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the cAd3-Marburg vaccine because, unlike most treatments that focus on managing symptoms of Marburg Virus Disease, this vaccine aims to prevent infection by triggering an immune response. Traditional care for Marburg Virus Disease primarily involves supportive treatments like rehydration and maintaining electrolyte balance, but this vaccine works differently by using a viral vector to stimulate the body's immune system. Additionally, the cAd3-Marburg vaccine is designed to be administered as a single intramuscular injection, which could simplify deployment and increase accessibility in outbreak situations. This novel approach offers hope for a proactive defense against the virus rather than just a reactive treatment.

What evidence suggests that the cAd3-Marburg vaccine might be an effective treatment for Marburg Virus Disease?

Research has shown that the cAd3-Marburg vaccine, which participants in this trial may receive, yielded promising results in early studies. In tests with animals, including monkeys, this vaccine and similar ones helped prevent Marburg virus disease, indicating effectiveness. Additionally, an earlier study with healthy adults found the vaccine to be safe and capable of triggering an immune response, suggesting potential protection for humans against the Marburg virus.678910

Who Is on the Research Team?

AG

Antonio Gonzalez-Lopez, MD, PhD, MPH

Principal Investigator

Albert B. Sabin Vaccine Institute

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to test a new vaccine against Marburg virus. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the vaccine's evaluation.

Inclusion Criteria

I agree not to get any vaccines 3 months before or after the trial vaccine.
Able to provide proof of identity to the satisfaction of the trial clinician completing the enrollment process; has a means to be contacted and to contact the investigator during the trial
In good general health without clinically significant medical conditions as deemed acceptable by PI
See 7 more

Exclusion Criteria

I have a history of blood disorders or risks for blood clots.
History of allergy to any component of the vaccine
I have taken certain medications or substances as specified.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single dose of cAd3-Marburg vaccine or placebo intramuscularly on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity at multiple timepoints post-vaccination

52 weeks
Visits on Days 8, 15, 29, 85, 169, and 366

What Are the Treatments Tested in This Trial?

Interventions

  • cAd3-Marburg vaccine
Trial Overview The trial is testing the safety and immune response to a new Marburg virus vaccine called cAd3-Marburg. Participants will be randomly assigned to receive either the investigational vaccine or a placebo, without knowing which one they get.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: cAd3-Marburg Vaccine (1.0 × 10^11 PU)Active Control1 Intervention
Group II: Placebo 0.9% NaCl solutionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albert B. Sabin Vaccine Institute

Lead Sponsor

Trials
12
Recruited
7,200+

Biomedical Advanced Research and Development Authority

Collaborator

Trials
108
Recruited
574,000+

Citations

Assessing the feasibility of Phase 3 vaccine trials against ...The median size of simulated outbreaks was 2 cases. Only 0.3% of simulated outbreaks were predicted to have more than 100 MVD cases. 95% of simulated outbreaks ...
Marburg Virus Disease in Rwanda, 2024 — Public Health ...On September 27, 2024, Rwanda reported an outbreak of Marburg virus disease (MVD), after a cluster of cases of viral hemorrhagic fever was ...
Marburg virus reaches Rwanda: how close are we to a ...Several candidate vaccines for Marburg virus have demonstrated protective efficacy in preclinical trials using non-human primate (NHP) models (Table 2).
NCT03475056 | cAd3-Marburg Vaccine in Healthy AdultsRV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular ...
Sabin Begins Marburg Vaccine Trial in U.S.Based on the cAd3 platform, Sabin's single-dose investigational Marburg vaccine was found to be promising in Phase 1 clinical and non-clinical ...
Safety, tolerability, and immunogenicity of the chimpanzee ...The cAd3-Marburg vaccine was safe, well tolerated, and immunogenic. All enrolled participants received cAd3-Marburg vaccine, with 37 (93%) ...
NCT03475056 | cAd3-Marburg Vaccine in Healthy AdultsNo safety issues were identified and an additional 17 participants were enrolled to complete Group 2. Participants were followed for approximately 48 weeks.
Marburg Vaccine Development ProgramWith no licensed vaccine currently available, Sabin's R&D program is advancing a chimpanzee-adenovirus type 3 (cAd3) vaccine to protect against this disease ...
9.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36709074/
a first-in-human, phase 1, open-label, dose-escalation trialThe cAd3-Marburg vaccine was safe, well tolerated, and immunogenic. All enrolled participants received cAd3-Marburg vaccine, with 37 (93 ...
Sabin cAd3-Marburg Vaccine Program Overview*Vaccinated HCW developed Marburg Virus Disease had mild symptoms and was discharged on Oct 30; considered unrelated to cAd3-Marburg Vaccine ...
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