A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (S… (NCT07565090) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
United States112 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. Any clinically relevant abnormality on history or examination including:
✕. 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
✕
What they're measuring
1
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity
Timeframe: 14 Days
2
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: unsolicited reactogenicity
Timeframe: 28 Days
3
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: SAEs and AESIs
✕. 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