Phase 2 Randomized Trial Evaluating Safety and Immune Response of rVSV94G-LASV-GPC Vaccine for Lassa Fever in Adults and Children in West Africa

What this Trial Is About

Researchers are investigating the safety, tolerability, and immune response of the rVSV94G-LASV-GPC vaccine in adults and children living in West Africa. This Phase 2 randomized, double-blinded, placebo-controlled trial builds on earlier studies that showed the vaccine was safe and triggered immune responses in animals and adults. The trial includes healthy adults, adults living with HIV, and children, aiming to expand knowledge before future effectiveness trials. Participants will receive one of two doses of the rVSV94G-LASV-GPC vaccine or a placebo. The study groups include healthy adults aged 18 to 70, HIV-infected adults aged 18 to 50, adolescents aged 12 to 17, children aged 6 to 11, and younger children aged 18 months to 5 years. The trial is randomized and triple-blinded, ensuring unbiased comparison between vaccine doses and placebo. The study monitors participants over several months to assess immune responses and vaccine shedding. During the study, participants will undergo medical evaluations, blood tests for antibody responses and vaccine presence, and monitoring for any side effects. Researchers will measure safety and tolerability up to seven months after vaccination and track immune responses and vaccine levels in blood, saliva, urine, and possibly reproductive fluids for up to 2.5 years. Participants and caregivers will complete questionnaires and attend follow-up visits as scheduled throughout the study duration.

A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa