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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

Primary Purpose

Lyme Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1975
mRNA-1982
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lyme Disease focused on measuring mRNA-1975, mRNA-1982, Vaccine, Lyme Disease Vaccine, Messenger RNA, Moderna

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Research Consulting, LLCRecruiting
  • Stamford Therapeutics ConsortiumRecruiting
  • Chase Medical Research, LLC
  • Jacksonville Center for Clinical ResearchRecruiting
  • University Clinical Research-DeLand, LLC d/b/a Accel Research SitesRecruiting
  • Clinical Research Atlanta, headlands LLC
  • Johnson County Clin-Trials, Inc. (JCCT)
  • Centennial Medical Group
  • Advanced Primary and Geriatric Care
  • DM Clinical Research - Brookline
  • Clinical Research Institute, Inc.
  • Velocity Clinical Research Providence
  • ActivMed Research LLC
  • Rochester Clinical Research, Inc.
  • Lynn Health Science Institute
  • Hatboro Medical Associates/CCT Research
  • Velocity Clinical Research Providence
  • Benchmark Research
  • DM Clinical ResearchRecruiting
  • Charlottesville Medical Research Center, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

mRNA-1975: Dose 1

mRNA-1975: Dose 2

mRNA-1975: Dose 3

mRNA-1975: Dose 4

mRNA-1982: Dose 1

mRNA-1982: Dose 2

mRNA-1982: Dose 3

Placebo

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants With Unsolicited Adverse Events (AEs)
Number of Participants With Medically Attended AEs
Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation

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

Full Information

First Posted
July 26, 2023
Last Updated
July 26, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05975099
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
March 12, 2026 (Anticipated)
Study Completion Date
March 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
mRNA-1975, mRNA-1982, Vaccine, Lyme Disease Vaccine, Messenger RNA, Moderna

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1975: Dose 1
Arm Type
Experimental
Arm Description
Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.
Arm Title
mRNA-1975: Dose 2
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.
Arm Title
mRNA-1975: Dose 3
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.
Arm Title
mRNA-1975: Dose 4
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.
Arm Title
mRNA-1982: Dose 1
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.
Arm Title
mRNA-1982: Dose 2
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.
Arm Title
mRNA-1982: Dose 3
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
Intervention Type
Biological
Intervention Name(s)
mRNA-1975
Other Intervention Name(s)
SR1-7
Intervention Description
Dispersion delivered IM
Intervention Type
Biological
Intervention Name(s)
mRNA-1982
Other Intervention Name(s)
SR1
Intervention Description
Dispersion delivered IM
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution delivered IM
Primary Outcome Measure Information:
Title
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 175 (7 days after each study injection)
Title
Number of Participants With Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 196 (28 days after each study injection)
Title
Number of Participants With Medically Attended AEs
Time Frame
Day 1 through Day 365 (6 months after the last study injection)
Title
Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation
Time Frame
Day 1 through Day 841 (End of Study)
Secondary Outcome Measure Information:
Title
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
Time Frame
Days 1, 29, 85, and 197
Title
Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Titer at Days 29, 85, and 197 Compared to Day 1 (Baseline)
Time Frame
Day 1 (Baseline), Days 29, 85, and 197

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
Clinical Research Consulting, LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Individual Site Status
Recruiting
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Name
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Atlanta, headlands LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Johnson County Clin-Trials, Inc. (JCCT)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Advanced Primary and Geriatric Care
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DM Clinical Research - Brookline
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research Providence
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
ActivMed Research LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hatboro Medical Associates/CCT Research
City
Hatboro
State/Province
Pennsylvania
ZIP/Postal Code
19040
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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