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Moderna tests mRNA shots to stop lyme disease

NCT ID NCT05975099

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tested two new mRNA vaccine candidates designed to prevent Lyme disease. It involved 807 healthy adults to see if the vaccines were safe and if they triggered a good immune response against the bacteria that causes Lyme. The study compared different doses of the vaccines against a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

807 people

The number who actually took part.

Started

Jul 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body mass index of 18 to 39 kilograms/square meter (inclusive) at the Screening Visit. * Participants of nonchildbearing potential may be enrolled in the study. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy during the study intervention period, and agreement to continue adequate contraception or abstinence through 3 months following last study injection. Exclusion Criteria: * 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. * Had previous vaccination against Lyme disease or participated in the past in any vaccine study for Lyme disease. * Had a tick bite within 4 weeks prior to the study injection visit. * Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos; psoriasis patches affecting skin over the deltoid areas). * Received systemic immunosuppressants for \>14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. * History of myocarditis, pericarditis, or myopericarditis regardless of the timing of past medical history. * History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study injection. * Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Lyme disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lyme disease

Contacts and locations

Locations

  • ActivMed Research LLC

    Newington, New Hampshire, 03801, United States

  • Advanced Primary and Geriatric Care

    Rockville, Maryland, 20850, United States

  • Benchmark Research

    Fort Worth, Texas, 76135, United States

  • Centennial Medical Group

    Columbia, Maryland, 21045, United States

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911, United States

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708, United States

  • Clinical Research Atlanta, headlands LLC

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Consulting, LLC

    Milford, Connecticut, 06460, United States

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402, United States

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • DM Clinical Research - Brookline

    Brookline, Massachusetts, 02445, United States

  • Encore Research Group-Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Hatboro Medical Associates/CCT Research

    Hatboro, Pennsylvania, 19040, United States

  • Johnson County Clin-Trials, Inc. (JCCT)

    Lenexa, Kansas, 66219, United States

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112, United States

  • Meridian Clinical Research - Omaha

    Omaha, Nebraska, 68134, United States

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609, United States

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905, United States

  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites

    Lake Mary, Florida, 32746, United States

  • Velocity Clinical Research Providence

    Providence, Rhode Island, 02886, United States

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