A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Adults (18 to 70 Years)

What this Trial Is About

Researchers are evaluating the safety, reactogenicity, and immune response of a new vaccine called mRNA-1982 designed to prevent Lyme disease in healthy adults aged 18 to 70 years. This Phase 2 clinical trial aims to find the best dose and assess how well the vaccine triggers the body's defenses against Lyme disease. Participants will receive either the mRNA-1982 vaccine or a placebo through an injection into the muscle. The study includes two main parts: a dose-finding phase where different doses are tested, and a booster phase where participants may receive a booster shot of the vaccine or placebo. Both phases monitor reactions shortly after the injections and track immune responses over several months. During the study, participants will undergo medical evaluations, including monitoring for any side effects or adverse events from the first day up to 21 months after injection. Researchers will measure immune responses by testing blood samples for specific antibodies at multiple time points during both phases. The total participation may last up to nearly two years to ensure thorough safety and immune response data collection.

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)