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.
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
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.
Single group
rVSVΔG-SUDV-GP
Biological/VaccinerVSVΔG-SUDV-GP
Placebo
Other interventionPlacebo
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
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
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
SUDV-GP-specific serum antibody responses
Proportion of participants with binding antibody responses to SUDV-GP
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)
SUDV-GP-specific serum antibody neutralization
Proportion of participants with neutralizing antibody against Sudan virus as measured by PRNT assay
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)
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International AIDS Vaccine Initiative
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
