Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT07425821

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

Led by International AIDS Vaccine Initiative · Updated on 2026-04-15

112

Participants Needed

2

Research Sites

118 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

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

CONDITIONS

Official 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

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults in good general health
  • Age between 18 and 50 years
  • Willing to follow study requirements and attend all follow-up visits
  • Agree to HIV testing, risk counseling, and receiving HIV test results
  • Sexually active participants must consistently use condoms for 3 months after vaccination
  • Individuals able to become pregnant must use effective contraception from 2 weeks before until 3 months after vaccination
  • Willing to have urine pregnancy tests as scheduled
  • Agree not to donate blood or tissues from screening through the study duration
Not Eligible

You will not qualify if you...

  • History of immunodeficiency, autoimmune disease, splenectomy, or cancer in the past 5 years
  • Use of corticosteroids, immunosuppressive, anticancer, or significant medications within 6 months
  • Body mass index (BMI) of 35.0 kg/m2 or higher
  • Any progressive or serious acute or chronic medical condition
  • Pregnant or breastfeeding individuals
  • Diagnosed bleeding disorder
  • Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B, current hepatitis C, active syphilis, or long COVID-19 syndrome
  • Serious infections requiring intravenous antibiotics, antivirals, or antifungals within 30 days before enrollment
  • Abnormal lab tests at screening
  • Received live vaccines within 14 to 30 days before or planned soon after vaccination
  • Blood transfusion within 3 months prior to enrollment
  • Previous exposure to Marburg Virus or history of hemorrhagic fever
  • Prior receipt of VSV-vectored, Marburg, or filovirus vaccines or monoclonal/polyclonal antibodies against filoviruses within 12 months
  • Participation in another clinical trial within 3 months prior to enrollment
  • History of severe vaccine reactions or severe allergies to vaccine components
  • Neuropsychiatric conditions or substance abuse affecting safety or protocol compliance
  • Living or working with individuals at higher risk from live viral vaccines like infants, elderly, or immunocompromised persons
  • Investigator's judgment that participation is not in the participant's best interest
  • History of long-term arthritis treatment of 4 weeks or more
  • Current rash or history of severe, chronic, or frequent rash

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

J

Johannes Beeslaar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here