← Back to all trials
Active Not Recruiting
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)
Conditions: Lyme Disease
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 366
Sponsor: ModernaTX, Inc.
Location: Colchester Research Group Truro Nova Scotia
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.
Source: ClinicalTrials.gov (NCT07561294). StuddyBuddy aggregates publicly available trial information.