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 Results 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 (5)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection

  Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 7 days after Day 1 injection

• Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection

  Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 7 days after Day 57 injection

• Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection

  Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 7 days after Day 169 injection

• Number of Participants With Unsolicited AEs

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 28 days post any injection

• Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation

  A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 up to Month 18

Secondary Outcomes (14)

• Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

  Days 1, 29, 85 and 197

• GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA

  Days 1, 29, 85, and 197

• GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA

  Days 1, 29, 85 and 197

• GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA

  Days 1, 29, 85 and 197

• GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA

  Days 1, 29, 85 and 197

Other Outcomes (1)

• Number of Deaths Related to Study Drug

  Day 1 up to Month 18

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

Related Publications (1)

• Finn MB, Willsey G, Piazza CL, Clendenen L, Shrestha M, You SS, Ma L, Dhingra Y, Laciak AR, Uggowitzer KA, Obiero JM, Freeman-Gallant G, Natarajan H, Green S, Pirayesh E, Lai YT, Himansu S, Carfi A, Hu LT, Mantis N, Plante O, Dold C. Monovalent and multivalent OspA mRNA-LNP vaccines elicit functional antibodies and protect against Borrelia burgdorferi in mice. NPJ Vaccines. 2026 May 5. doi: 10.1038/s41541-026-01451-7. Online ahead of print.

  PMID: 42086599 DERIVED

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

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: July 30, 2026
• Results First Posted: July 30, 2026

Record last verified: 2026-07

Locations

US (20)