mRNA-1982 vaccine to prevent Lyme disease in adults 18–70
A Phase 2, Randomized, Observer-blind, Dose-finding, Placebo-controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982, an mRNA Vaccine to Prevent Lyme Disease in Healthy Adult Participants (18 to 70 Years of Age)
This trial will test whether the mRNA-1982 vaccine is safe and triggers an immune response to help prevent Lyme disease in healthy adults aged 18 to 70.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ModernaTX, Inc. Industry-sponsored |
| Locations | 8 sites (Truro, Nova Scotia and 7 other locations) |
| Trial ID | NCT07561294 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2 interventional study of monovalent mRNA-1982 compared with placebo in healthy adults aged 18 to 70. Participants who meet inclusion criteria will receive injections of mRNA-1982 or placebo and return for scheduled follow-up visits. The study will closely monitor safety and reactogenicity (local and systemic reactions) and measure immune responses to the vaccine. Data will be used to inform further development of the vaccine.
Who should consider this trial
Good fit: Healthy adults aged 18 to 70 without active or recent Lyme disease, no prior Lyme vaccine, and no history of severe allergic reactions to mRNA vaccines are the intended participants.
Not a fit: People who have active Lyme infection, recently treated Lyme disease, a prior Lyme vaccine, a recent tick bite, or a history of severe reaction to mRNA products are unlikely to benefit from joining this study.
Why it matters
Potential benefit: If successful, the vaccine could provide a safe way to prevent Lyme disease in adults and reduce the number of infections.
How similar studies have performed: mRNA vaccine technology has shown strong success for other infectious diseases, but using an mRNA platform for Lyme prevention is a newer approach with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * In good general health in the opinion of the investigator as determined by medical evaluation including medical history and physical examination at screening. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Key Exclusion Criteria: * History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic. * Have chronic illness related to Lyme disease or an active symptomatic Lyme disease infection as suspected or diagnosed by a physician. * Received treatment for Lyme disease within the prior 3 months. * Previously vaccinated against Lyme disease or participated in the past in any vaccine study for Lyme disease. * Had a tick bite within 4 weeks prior to Day 1. Note: Additional inclusion/exclusion criteria may apply, per protocol.
Where this trial is running
Truro, Nova Scotia and 7 other locations
- Colchester Research Group — Truro, Nova Scotia, Canada (Recruiting)
- Bluewater Clinical Research Group Inc. — Sarnia, Ontario, Canada (Not_yet_recruiting)
- Stouffville Medical Research Institute Inc. — Stouffville, Ontario, Canada (Not_yet_recruiting)
- Dr. Anil K. Gupta Medicine Professional Corporation Inc. — Toronto, Ontario, Canada (Not_yet_recruiting)
- Diex Recherche Inc. - Division Joliette — Joliette, Quebec, Canada (Not_yet_recruiting)
- Diex Recherche Inc. - Division Sherbrooke — Sherbrooke, Quebec, Canada (Not_yet_recruiting)
- Diex Recherche Inc. - Division Victoriaville — Victoriaville, Quebec, Canada (Not_yet_recruiting)
- Diex Recherche Inc. - Division Quebec — Québec, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Moderna WeCare Team
- Email: WeCareClinicalTrials@modernatx.com
- Phone: 1-866-663-3762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.