A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health

A Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-SUDV-GP Vaccine in Adults in Good General Health

A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health.

Study Overview

• Status: Not yet recruiting
• Conditions: Sudan Virus Disease
• Intervention / Treatment: Other: Placebo; Biological: rVSVΔG-SUDV-GP

Detailed Description

This is a Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SUDV-GP Vaccine in Adults in Good General Health. Participants will be screened up to 28 days before Investigational Product (IP) administration and will be followed for 6 months after IP administration. The study will evaluate 4 different dose levels (2 X106 1X107, 2 X 107, 5 X 107) in 4 different participant groups for which enrollment will initiate sequentially. Starting with the lowest dose group, four sentinel participants will be enrolled in a sequential manner with no more than one participant enrolled across all sites per day. A safety review will be performed by the Sponsor after enrollment of the fourth sentinel participant, after which point the remainder of participants will be enrolled in group 1. In addition, a safety assessment will be performed by the Sponsor before opening enrollment in group 2. This assessment will be performed after enrollment of the 9th participant in group 1. The same sentinel dosing followed by safety reviews approach will be repeated for each group at each dose level.[

• 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, 20037
      • George Washington University
      • Contact: Christina Gibbs Tewary; Phone Number: 202-994-2909; Email: christinag1@email.gwu.edu
      • Contact: Aimee Desrosiers; Email: adesrosiers@mfa.gwu.edu
      • Principal Investigator: David Diemert, MD
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials
      • Contact: Thomas Kreamer, MD; Phone Number: 913-825-4400; Email: tkreamer@jcct.com
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Principal Investigator: Lindsey Baden, MD
      • Contact: Natalie Izaguirre; Phone Number: 617-732-6801; Email: nataliee_izaguirre@dfci.harvard.edu

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. In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed
5. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
6. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration
7. 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
8. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)
9. 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: rVSVΔG-SUDV-GP	Biological: rVSVΔG-SUDV-GP; rVSVΔG-SUDV-GP
Placebo Comparator: Placebo; Placebo/Diluent	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of rVSVΔG-SUDV-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 rVSVΔG-SUDV-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 rVSVΔG-SUDV-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
SUDV-GP-specific serum antibody responses	Proportion of participants with binding antibody responses to SUDV-GP	Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody responses magnitude and duration	Magnitude and duration of binding antibody to SUDV-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 immunization
SUDV-GP-specific serum antibody neutralization	Proportion of participants with neutralizing antibody against Sudan virus as measured by PRNT assay	Throughout the study, up to 6 months after immunization
SUDV-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 immunization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Infections; Virus diseases; Ebola; Hemorrhagic fever; Sudan virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Mononegavirales Infections; Filoviridae Infections; Infections; Virus Diseases; Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
• Other Study ID Numbers: IAVI C109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD sharing plans are currently under internal discussion.

Drug and device information, study documents

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