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

Lyme Disease Clinical Trial

Official title:

A Phase 1/2, Randomized, Observer-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Immunogenicity of Heptavalent mRNA-1975 (SR1-7) and Monovalent mRNA-1982 (SR1) in Parallel Against Lyme Disease in Healthy Participants 18 Through 70 Years of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05975099
• Other study ID #: mRNA-1975/1982-P101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 26, 2023
• Est. completion date: March 12, 2026

Study information

• Verified date: December 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 807
• Est. completion date: March 12, 2026
• Est. primary completion date: March 12, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Biological:
• mRNA-1975
Dispersion delivered IM
• mRNA-1982
Dispersion delivered IM
• Placebo
Solution delivered IM

Locations

Country	Name	City	State
United States	DM Clinical Research - Brookline	Brookline	Massachusetts
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Velocity Clinical Research Providence	East Greenwich	Rhode Island
United States	Centennial Medical Group	Elkridge	Maryland
United States	Benchmark Research	Fort Worth	Texas
United States	Hatboro Medical Associates/CCT Research	Hatboro	Pennsylvania
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	University Clinical Research-DeLand, LLC d/b/a Accel Research Sites	Lake Mary	Florida
United States	Johnson County Clin-Trials, Inc. (JCCT)	Lenexa	Kansas
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Velocity Clinical Research Providence	Omaha	Nebraska
United States	ActivMed Research LLC	Portsmouth	New Hampshire
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Advanced Primary and Geriatric Care	Rockville	Maryland
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Clinical Research Atlanta, headlands LLC	Stockbridge	Georgia
United States	DM Clinical Research	Tomball	Texas
United States	Chase Medical Research, LLC	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 175 (7 days after each study injection)
Primary	Number of Participants With Unsolicited Adverse Events (AEs)		Up to Day 196 (28 days after each study injection)
Primary	Number of Participants With Medically Attended AEs		Day 1 through Day 365 (6 months after the last study injection)
Primary	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 841 (End of Study)
Secondary	Geometric Mean Titer 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
Secondary	Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Titer at Days 29, 85, and 197 Compared to Day 1 (Baseline)		Day 1 (Baseline), Days 29, 85, and 197