NCT07561294 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)
| NCT ID | NCT07561294 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ModernaTX, Inc. |
| Condition | Lyme Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2028-11-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 350 participants in total. It began in 2026-04-29 with a primary completion date of 2028-11-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07561294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Lyme Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07561294 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07561294 currently recruiting?
Yes, NCT07561294 is actively recruiting participants. Contact the research team at WeCareClinicalTrials@modernatx.com for enrollment information.
Where is the NCT07561294 trial being conducted?
This trial is being conducted at Truro, Canada, Sarnia, Canada, Stouffville, Canada, Toronto, Canada and 4 additional locations.
Who is sponsoring the NCT07561294 clinical trial?
NCT07561294 is sponsored by ModernaTX, Inc.. The trial plans to enroll 350 participants.