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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
112
rVSVΔG-SUDV-GP
Placebo
George Washington University
Washington D.C., District of Columbia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
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
Time frame: 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
Time frame: 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
Time frame: 7 Months
SUDV-GP-specific serum antibody responses
Proportion of participants with binding antibody responses to SUDV-GP
Time frame: 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)
Time frame: 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
Time frame: Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody magnitude and duration of neutralization
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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)
Time frame: Throughout the study, up to 6 months after immunization