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

NCT07565090 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IAVI C109
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sudan Virus Disease

Keywords

Sudan virus; Infections; Virus diseases; Hemorrhagic fever; Ebola

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• SUDV-GP-specific serum antibody responses

  Throughout the study, up to 6 months after immunization

• SUDV-GP-specific serum antibody responses magnitude and duration

  Throughout the study, up to 6 months after immunization

• SUDV-GP-specific serum antibody neutralization

  Throughout the study, up to 6 months after immunization

• SUDV-GP-specific serum antibody magnitude and duration of neutralization

  Throughout the study, up to 6 months after immunization

Study Arms (2)

rVSVΔG-SUDV-GP

EXPERIMENTAL

rVSVΔG-SUDV-GP

Biological: rVSVΔG-SUDV-GP

Placebo

PLACEBO COMPARATOR

Placebo/Diluent

Other: Placebo

Interventions

Placebo OTHER

Placebo

Placebo

rVSVΔG-SUDV-GP BIOLOGICAL

rVSVΔG-SUDV-GP

rVSVΔG-SUDV-GP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed
• 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
• 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

You may not qualify if:

• 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
• 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
• Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever
• 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
• Current participation in another clinical trial, within 3 months prior to enrollment.
• 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.
• Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol
• 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

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (3)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Infections; Virus Diseases; Hemorrhagic Fevers, Viral; Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

RNA Virus Infections; Filoviridae Infections; Mononegavirales Infections

Central Study Contacts

Johannes Beeslaar, MD

CONTACT

212-328-7459; JBeeslaar@iavi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This will be an observer-blind study. Investigators and participants will remain blinded to treatment assignment throughout the duration of the study. Unblinded site pharmacists will be responsible for investigational product preparation. The active product and placebo will be identical in appearance to maintain the blind. The Sponsor and study statistician will be unblinded. Strict data firewalls will be maintained to ensure that no unblinded information is shared with blinded clinical site staff until the database is locked.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (3)