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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05975099

Collaborator

(none)

800

Enrollment

Locations

Arms

31.5

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lyme Disease	Biological: mRNA-1975 Biological: mRNA-1982 Biological: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 26, 2023

Anticipated Primary Completion Date :

Mar 12, 2026

Anticipated Study Completion Date :

Mar 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mRNA-1975: Dose 1 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 Dispersion delivered IM Other Names: SR1-7
Experimental: mRNA-1975: Dose 2 Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.	Biological: mRNA-1975 Dispersion delivered IM Other Names: SR1-7
Experimental: mRNA-1975: Dose 3 Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.	Biological: mRNA-1975 Dispersion delivered IM Other Names: SR1-7
Experimental: mRNA-1975: Dose 4 Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.	Biological: mRNA-1975 Dispersion delivered IM Other Names: SR1-7
Experimental: mRNA-1982: Dose 1 Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.	Biological: mRNA-1982 Dispersion delivered IM Other Names: SR1
Experimental: mRNA-1982: Dose 2 Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.	Biological: mRNA-1982 Dispersion delivered IM Other Names: SR1
Experimental: mRNA-1982: Dose 3 Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.	Biological: mRNA-1982 Dispersion delivered IM Other Names: SR1
Placebo Comparator: Placebo Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.	Biological: Placebo Solution delivered IM

Outcome Measures

Primary Outcome Measures

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 365 (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 841 (End of Study)]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Consulting, LLC	Milford	Connecticut	United States	06460
2	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
3	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
4	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
5	University Clinical Research-DeLand, LLC d/b/a Accel Research Sites	Lake Mary	Florida	United States	32746
6	Clinical Research Atlanta, headlands LLC	Stockbridge	Georgia	United States	30281
7	Johnson County Clin-Trials, Inc. (JCCT)	Lenexa	Kansas	United States	66219
8	Centennial Medical Group	Elkridge	Maryland	United States	21075
9	Advanced Primary and Geriatric Care	Rockville	Maryland	United States	20850
10	DM Clinical Research - Brookline	Brookline	Massachusetts	United States	02445
11	Clinical Research Institute, Inc.	Minneapolis	Minnesota	United States	55402
12	Velocity Clinical Research Providence	Omaha	Nebraska	United States	68134
13	ActivMed Research LLC	Portsmouth	New Hampshire	United States	03801
14	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
15	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
16	Hatboro Medical Associates/CCT Research	Hatboro	Pennsylvania	United States	19040
17	Velocity Clinical Research Providence	East Greenwich	Rhode Island	United States	02818
18	Benchmark Research	Fort Worth	Texas	United States	76135
19	DM Clinical Research	Tomball	Texas	United States	77375
20	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia	United States	22911