A Phase 1 Randomized, Observer Blind, Placebo-controlled, Dose-escalation and dose expansion Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
This is a observer-blind, Phase 1 Randomized, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health. The study is a dose escalation study that will administer 4 different dose levels to 4 different groups. The lowest dose level will be given and then a safety assessment will occur before escalation to the next dose level. This gradual dosing followed by a safety assessment will be repeated at each dose level. Approximately 112 participants will be given vaccine (rVSV∆G-MARV-GP) or placebo. This IAVI C104 study will look at the safety, tolerability and immunogenicity of the rVSV Marburg virus vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
112
rVSV∆G-MARV-GP
Placebo
George Washington University
Washington D.C., District of Columbia, United States
RECRUITINGJohnson County Clin-Trials
Lenexa, Kansas, United States
RECRUITINGSafety and tolerability of rVSV∆G-MARV-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 rVSV∆G-MARV-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 rVSV∆G-MARV-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
MARV-GP-specific serum antibody responses
Proportion of participants with binding antibody responses to MARV-GP
Time frame: Throughout the study, up to 6 months after immunisation
MARV-GP-specific serum antibody responses magnitude and duration
Magnitude and duration of binding antibody to MARV-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 immunisation
MARV-GP-specific serum antibody neutralization
Proportion of participants with neutralizing antibody against Marburg virus as measured by PRNT assay
Time frame: Throughout the study, up to 6 months after immunisation
MARV-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 immunisation