A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health
This is a Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health. Approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study Participants will be screened up to 42 days before IP administration and will be followed for 12 months after IP administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
114
2 × 10\^4 pfu delivered intramuscularly
2 × 10\^5 pfu delivered intramuscularly
2 × 10\^6 pfu delivered intramuscularly
George Washington University
Washington D.C., District of Columbia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Brigham and Women's Hospital
Brookline, Massachusetts, United States
Redemption Hospital
New Kru Town, Greater Monrovia, Liberia
Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
* Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during a 14-day follow-up period after IP administration * Proportion of participants with Grade 2 or higher IP-related unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration * Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration * Proportion of participants with IP-related SAEs throughout the study period Proportion of participants with AEs of Special Interest (AESI) post-vaccination throughout the study period
Time frame: 20 months
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
* Magnitude and duration of viral RNA in plasma by PCR * Magnitude and duration of rVSV∆G-LASV-GPC vaccine viremia by culture * Magnitude and duration of viral RNA in urine and saliva by PCR * Magnitude and duration of rVSV∆G-LASV-GPC vaccine shedding in urine and saliva by culture
Time frame: 20 months
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2 × 10\^7 pfu delivered intramuscularly
N/A delivered intramuscularly