Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa

C105 - Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of rVSVΔG- LASVGPC Vaccine in Adults and Children Residing in West Africa study

Objectives

Primary

• To evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children

Secondary

• To determine LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine
• To determine neutralizing LASVGPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants in each group
• To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine viremia in plasma in a subset of participants
• To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine shedding in saliva and urine, and possibly semen and cervicovaginal fluid, in a subset of participants

Exploratory

• To explore the characteristics of the immune responses induced by rVSVΔGLASV-GPC vaccine in a subset of participants