A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age

NCT05975099 | Completed Phase 1 FDA Drug

• 1 other identifier: mRNA-1975/1982-P101
• Study Type: interventional
• Target: 807
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.

Conditions

Lyme Disease

Keywords

mRNA-1975; mRNA-1982; Vaccine; Lyme Disease Vaccine; Messenger RNA; Moderna

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 175 (7 days after each study injection)

• Number of Participants With Unsolicited Adverse Events (AEs)

  Up to Day 196 (28 days after each study injection)

• Number of Participants With Medically Attended AEs

  Day 1 through Day 337 (6 months after the last study injection)

• Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation

  Day 1 through Day 505 (End of Study)

Secondary Outcomes (2)

• Geometric Mean Concentration of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method

  Days 1, 29, 85, and 197

• Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Concentration at Days 29, 85, and 197 Compared to Day 1 (Baseline)

  Days 29, 85, and 197

Study Arms (8)

mRNA-1975: Dose 1

EXPERIMENTAL

Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.

Biological: mRNA-1975

mRNA-1975: Dose 2

EXPERIMENTAL

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.

Biological: mRNA-1975

mRNA-1975: Dose 3

EXPERIMENTAL

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.

Biological: mRNA-1975

mRNA-1975: Dose 4

EXPERIMENTAL

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.

Biological: mRNA-1975

mRNA-1982: Dose 1

EXPERIMENTAL

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.

Biological: mRNA-1982

mRNA-1982: Dose 2

EXPERIMENTAL

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.

Biological: mRNA-1982

mRNA-1982: Dose 3

EXPERIMENTAL

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.

Biological: mRNA-1982

Placebo

PLACEBO COMPARATOR

Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.

Biological: Placebo

Interventions

mRNA-1975 BIOLOGICAL

Dispersion delivered IM

Also known as: SR1-7

mRNA-1975: Dose 1; mRNA-1975: Dose 2; mRNA-1975: Dose 3; mRNA-1975: Dose 4

mRNA-1982 BIOLOGICAL

Dispersion delivered IM

Also known as: SR1

mRNA-1982: Dose 1; mRNA-1982: Dose 2; mRNA-1982: Dose 3

Placebo BIOLOGICAL

Solution delivered IM

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (20)

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Encore Research Group-Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

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

Lake Mary, Florida, 32746, United States

Location

Clinical Research Atlanta, headlands LLC

Stockbridge, Georgia, 30281, United States

Location

Johnson County Clin-Trials, Inc. (JCCT)

Lenexa, Kansas, 66219, United States

Location

Centennial Medical Group

Columbia, Maryland, 21045, United States

Location

Advanced Primary and Geriatric Care

Rockville, Maryland, 20850, United States

Location

DM Clinical Research - Brookline

Brookline, Massachusetts, 02445, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Meridian Clinical Research - Omaha

Omaha, Nebraska, 68134, United States

Location

ActivMed Research LLC

Newington, New Hampshire, 03801, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Hatboro Medical Associates/CCT Research

Hatboro, Pennsylvania, 19040, United States

Location

Velocity Clinical Research Providence

Providence, Rhode Island, 02886, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: July 26, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (20)