Actively Recruiting
Phase 1 Randomized, Observer-blind, Placebo-controlled Dose-escalation Study of rVSV6G-MARV-GP Vaccine in Healthy Adults
Led by International AIDS Vaccine Initiative · Updated on 2026-04-15
112
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
I
International AIDS Vaccine Initiative
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and immune response of the rVSV6G-MARV-GP vaccine in adults who are in good general health. This Phase 1 clinical trial uses a randomized, observer-blind, placebo-controlled design to evaluate different dose levels of the vaccine. The study focuses on understanding how the vaccine affects the body and its ability to trigger an immune response against Marburg Virus Disease. Participants will receive one of four different dose levels of the rVSV6G-MARV-GP vaccine or a placebo. The dosing starts at the lowest level and gradually increases after safety checks at each stage. About 112 adults will be involved, and the vaccine or placebo will be given following a careful dose-escalation plan to ensure safety at each step. During the study, participants will be monitored closely for safety, including common side effects and serious adverse events up to seven months after vaccination. Their immune response will be measured through blood tests over six months to assess antibody levels and neutralization. The trial includes regular follow-up visits and testing, with a total participation duration extending up to several months to evaluate both short and longer-term effects of the vaccine.
CONDITIONS
Brief Title
A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults in good general health
- Aged 18 to 50 years
- Willing to comply with study requirements and available for follow-up
- Agree to HIV testing, counseling, and receive test results
- Sexually active participants must use condoms consistently for 3 months after vaccination
- Individuals of childbearing potential must use effective contraception from 2 weeks before until 3 months after vaccination
- Willing to undergo urine pregnancy tests as scheduled
- Willing to avoid donating blood or tissues during the study
You will not qualify if you...
- History of immunodeficiency, autoimmune disease, splenectomy, or malignancy in past 5 years
- Use of steroids, immunosuppressants, anticancer drugs, or other significant medications within 6 months
- Body mass index (BMI) of 35 or higher
- Any progressive or serious medical condition unsuitable for study participation
- Pregnant or breastfeeding individuals
- Bleeding disorders diagnosed by a doctor
- Confirmed HIV-1 or HIV-2 infection, chronic hepatitis B or C, active syphilis, or long COVID-19 syndrome
- Active serious infections requiring intravenous antibiotics, antivirals, or antifungals within 30 days
- Abnormal lab results at screening
- Recent or planned receipt of live or non-live vaccines within defined timeframes
- Blood transfusion or blood product receipt within 3 months
- Prior exposure to Marburg virus or hemorrhagic fever history
- Previous receipt of VSV-vectored, Marburg, or filovirus vaccines or antibodies within 12 months
- Participation in another clinical trial within 3 months
- Severe vaccine reactions or allergies to vaccine components
- Neuropsychiatric conditions or substance abuse affecting safety or compliance
- Occupational or household contact with individuals at risk from live viral vaccine exposure
- Investigator judgment against participation
- Long-term arthritis treatment (4 weeks or more)
- Current or history of severe, chronic, or frequent rash, or current rash
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on dose escalation schedule
Participants receive one of four dose levels of the rVSV∆G-MARV-GP vaccine or placebo, with safety assessments after each dose escalation.
Multiple visits for vaccination and safety assessments
Duration - Up to 6 months
Participants are monitored for safety, tolerability, and immune response for up to 6 months after vaccination.
Regular follow-up visits over 6 months
Trial Site Locations
Total: 2 locations
1
George Washington University
Washington D.C., District of Columbia, United States, 20052
Actively Recruiting
2
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Actively Recruiting
Research Team
J
Johannes Beeslaar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
Frequently Asked Questions
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