Skip to main content
OpenTrials
Recruiting

NCT Number: 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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lyme Disease Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Gram-Negative Bacterial Infections Infections Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Colchester Research Group, Truro, Nova Scotia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA-1982

Biological

Suspension for injection

Placebo

Biological

Suspension for injection

Primary outcomes

  1. Both Phases: Number of Participants with Solicited Local and Systemic Adverse Reactions

    Time frame: Day 1 up to Day 7 (7 days post-injection)

  2. Both Phases: Number of Participants with Unsolicited Adverse Events

    Time frame: Day 1 up to Day 28 (28 days post-injection)

  3. Both Phases: Number of Participants with Medically Attended Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and Adverse Events Leading to Discontinuation

    Time frame: Day 1 up to Month 21 (End of study)

Secondary outcomes

  1. Dose-finding Phase: Geometric Mean Concentration (GMC) of Anti-outer Surface Protein A (OspA) Serotype 1 (ST1) Binding Immunoglobulin G (IgG) Antibodies (Ab)

    Time frame: Days 1, 113, 197, 265, and 349

  2. Dose-finding Phase: Geometric Mean Fold Rise (GMFR) of Anti-OspA ST1 Binding IgG Ab

    Time frame: Days 113, 197, 265, and 349

  3. Booster Phase: GMC of Anti-OspA ST1 Binding IgG Ab

    Time frame: Days 1, 29, and 181 of Booster Phase

  4. Booster Phase: GMFR of Anti-OspA ST1 Binding IgG Ab

    Time frame: Days 29 and 181 of Booster Phase

Study contacts

Contact information is provided by the study sponsor or research team.

Moderna WeCare Team

CONTACT

[email protected]

1-866-663-3762

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 1, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.