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

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

Study Overview

• Status: Recruiting
• Conditions: Marburg Virus Disease
• Intervention / Treatment: Other: Placebo; Biological: rVSV∆G-MARV-GP

Detailed Description

This is a observer-blind, Phase 1 Randomized, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health. The study is a dose escalation study that will administer 4 different dose levels to 4 different groups. The lowest dose level will be given and then a safety assessment will occur before escalation to the next dose level. This gradual dosing followed by a safety assessment will be repeated at each dose level.

Approximately 112 participants will be given vaccine (rVSV∆G-MARV-GP) or placebo.

This IAVI C104 study will look at the safety, tolerability and immunogenicity of the rVSV Marburg virus vaccine.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Johannes Beeslaar, MD; Phone Number: 212-328-7459; Email: JBeeslaar@iavi.org

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • Recruiting
      • George Washington University
      • Contact: David Diemert, MD; Phone Number: 202-994-2909; Email: ddiemert@gwu.edu
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Recruiting
      • Johnson County Clin-Trials
      • Contact: Matt Helbig; Phone Number: 919-539-2642; Email: mhelbig@jcct.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rVSV∆G-MARV-GP	Biological: rVSV∆G-MARV-GP; rVSV∆G-MARV-GP
Placebo Comparator: Placebo/Diluent	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of rVSV∆G-MARV-GP vaccination: solicited reactogenicity	Occurrence, onset, duration, and severity of local and systemic solicited adverse events within 14 days following vaccination	14 Days
Safety and tolerability of rVSV∆G-MARV-GP vaccination: unsolicited reactogenicity	Occurrence, onset, duration, severity, and relationship to IP of unsolicited adverse events, including safety laboratory parameters, within 28 days following vaccination	28 days
Safety and tolerability of rVSV∆G-MARV-GP vaccination: SAEs and AESIs	Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period	7 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MARV-GP-specific serum antibody responses	Proportion of participants with binding antibody responses to MARV-GP	Throughout the study, up to 6 months after immunisation
MARV-GP-specific serum antibody responses magnitude and duration	Magnitude and duration of binding antibody to MARV-GP throughout the full study period (1 week, 2 weeks, 4 weeks, 2 months, 3 months, 6 months after immunization)	Throughout the study, up to 6 months after immunisation
MARV-GP-specific serum antibody neutralization	Proportion of participants with neutralizing antibody against Marburg virus as measured by PRNT assay	Throughout the study, up to 6 months after immunisation
MARV-GP-specific serum antibody magnitude and duration of neutralization	Magnitude and duration of neutralizing antibody against Marburg virus as measured by PRNT assay throughout the full study period (1 week, 2 weeks, 4 weeks, 2 months, 3 months, 6 months after immunization)	Throughout the study, up to 6 months after immunisation

Collaborators and Investigators

• Sponsor: International AIDS Vaccine Initiative
• Collaborators: Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Hemorrhagic Fevers, Viral; Mononegavirales Infections; Filoviridae Infections; Animal Diseases; Primate Diseases; Monkey Diseases; Marburg Virus Disease
• Other Study ID Numbers: IAVI C104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No