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)

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07561294

Enrollment

366

Registered

2026-05-01

Start date

2026-04-29

Completion date

2028-11-09

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Disease

Keywords

Moderna, mRNA-1982, Messenger RNA, Safety, Vaccines

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.

Interventions

BIOLOGICALmRNA-1982

Suspension for injection

BIOLOGICALPlacebo

Suspension for injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions	Day 1 up to Day 7 (7 days post-injection)
Both Phases: Number of Participants with Unsolicited Adverse Events	Day 1 up to Day 28 (28 days post-injection)
Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation	Day 1 up to Month 21 (End of study)

Secondary

Measure	Time frame
Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)	Days 1, 113, 197, 265, and 349
Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab	Days 113, 197, 265, and 349
Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab	Days 1, 29, and 181 of Booster Phase
Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab	Days 29 and 181 of Booster Phase

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026