Phase 1 Trial Evaluating mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adults Aged 18 to 65

What this Trial Is About

This research aims to evaluate the safety and reactions caused by the mRNA-1469 vaccine designed to prevent Ebola-Bundibugyo Virus Disease in healthy adults aged 18 to 65. The study is a Phase 1 trial sponsored by ModernaTX, Inc., focusing on understanding local and systemic adverse reactions, as well as immune response, to this vaccine. Participants include adults in good health or with stable chronic conditions, with a body mass index between 18.5 and 39 kgm2. Participants will be randomly assigned to receive a single injection on Day 1 of either one of three dose levels of the mRNA-1469 vaccine or a matching placebo injection. The study uses a quadruple masking design to compare the effects across six groups three experimental vaccine dose levels and three placebo groups. The trial includes follow-ups extending up to 337 days to monitor safety and immune response. During the study, participants will be monitored for various outcomes including local and systemic reactions during the first 7 days after injection, any adverse events up to 28 days, medically attended adverse events for 6 months, and serious adverse events or events leading to discontinuation throughout the study. Immune response is assessed by measuring specific antibodies at Day 29 and through Day 337. The total participation time can last nearly 11 months with regular safety checks and laboratory assessments.

A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants