A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evalu… (NCT07425821) | Clinical Trial Compass
RecruitingPhase 1
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
United States112 participantsStarted 2026-03-27
Plain-language summary
A Phase 1 Randomized, Observer Blind, Placebo-controlled, Dose-escalation and dose expansion Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults in good general health
. Participants who are 18 to 50 years of age
. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration
. All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine/placebo
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of rVSV∆G-MARV-GP vaccination: solicited reactogenicity
Timeframe: 14 Days
2
Safety and tolerability of rVSV∆G-MARV-GP vaccination: unsolicited reactogenicity
Timeframe: 28 days
3
Safety and tolerability of rVSV∆G-MARV-GP vaccination: SAEs and AESIs
. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)
. All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study
Exclusion criteria
. Any clinically relevant abnormality on history or examination including:
. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
. Individuals who are pregnant or breastfeeding
. Bleeding disorder that was diagnosed by a physician
. Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.
. Any abnormal laboratory parameters at screening per protocol.
. Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines
. Receipt of blood transfusion or blood-derived products within the previous 3 months