rVSV∆G‑MARV‑GP vaccine dose‑escalation in healthy adults

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

We will test different doses of the rVSV∆G‑MARV‑GP vaccine or placebo in healthy adults aged 18–50 to see if it is safe and sparks an immune response.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: International AIDS Vaccine Initiative (Research network)
• Locations: 2 sites (Washington D.C., District of Columbia and 1 other locations)
• Trial ID: NCT07425821 on ClinicalTrials.gov

What this trial studies

This is a randomized, observer‑blind, placebo‑controlled Phase 1 dose‑escalation trial enrolling healthy adults. Participants are assigned to one of four escalating dose groups, with safety reviews between each dose level before proceeding. About 112 participants will receive either the vaccine or placebo and be followed for safety, tolerability, and immune responses. The study will measure adverse events and antibody responses over the planned follow‑up period.

Who should consider this trial

Good fit: Healthy adults aged 18–50 in good general health who can attend follow‑up visits and agree to contraception and condom use as required are the intended participants.

Not a fit: People under 18 or over 50, those with significant health issues, pregnant individuals, or those unwilling to follow contraception/condom and follow‑up rules are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could generate protective immune responses against Marburg virus and support further development toward a licensed vaccine.

How similar studies have performed: Related rVSV vaccine platforms have shown success for Ebola and rVSV‑based Marburg vaccines have shown protective results in preclinical studies, but human data are still limited.

Eligibility criteria

Inclusion Criteria

1. Adults in good general health
2. Participants who are 18 to 50 years of age
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
4. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
5. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration
6. 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
7. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)
8. 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

1. Any clinically relevant abnormality on history or examination including:

   history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg/m2
2. 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
3. Individuals who are pregnant or breastfeeding
4. Bleeding disorder that was diagnosed by a physician
5. 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.
6. Any abnormal laboratory parameters at screening per protocol.
7. 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
8. Receipt of blood transfusion or blood-derived products within the previous 3 months
9. Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever
10. Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months
11. Current participation in another clinical trial, within 3 months prior to enrollment.
12. History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and/or allergy to any component of this vaccine.
13. Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol
14. Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults ≥75 years of age, or immunocompromised individuals.
15. In the opinion of the PI, it is not in the best interest of the participant to participate in the trial
16. A history of long-term treatment (≥ 4 weeks) for arthritis
17. Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.

Where this trial is running

Washington D.C., District of Columbia and 1 other locations

• George Washington University — Washington D.C., District of Columbia, United States (Recruiting)
• Johnson County Clin-Trials — Lenexa, Kansas, United States (Recruiting)

Study contacts

• Study coordinator: Johannes Beeslaar, MD

Conditions Marburg Virus Disease