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History of Changes for Study: NCT05975099
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
Latest version (submitted December 20, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 26, 2023 None (earliest Version on record)
2 December 1, 2023 Study Status and Contacts/Locations
3 December 20, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT05975099
Submitted Date:  July 26, 2023 (v1)

Open or close this module Study Identification
Unique Protocol ID: mRNA-1975/1982-P101
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2023
Overall Status: Recruiting
Study Start: July 26, 2023
Primary Completion: March 12, 2026 [Anticipated]
Study Completion: March 12, 2026 [Anticipated]
First Submitted: July 26, 2023
First Submitted that
Met QC Criteria:
July 26, 2023
First Posted: August 3, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
July 26, 2023
Last Update Posted: August 3, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Lyme Disease
Keywords: mRNA-1975
mRNA-1982
Vaccine
Lyme Disease Vaccine
Messenger RNA
Moderna
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 8
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 800 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
[ Time Frame: Up to Day 175 (7 days after each study injection) ]

2. Number of Participants With Unsolicited Adverse Events (AEs)
[ Time Frame: Up to Day 196 (28 days after each study injection) ]

3. Number of Participants With Medically Attended AEs
[ Time Frame: Day 1 through Day 365 (6 months after the last study injection) ]

4. 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 Measures:
1. 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 ]

2. 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.

Open or close this module Contacts/Locations
Central Contact Person: Moderna Clinical Trials Support Center
Telephone: 1-877-777-7187
Email: clinicaltrials@modernatx.com
Locations: United States, Connecticut
Clinical Research Consulting, LLC
[Recruiting]
Milford, Connecticut, United States, 06460
Stamford Therapeutics Consortium
[Recruiting]
Stamford, Connecticut, United States, 06905
Chase Medical Research, LLC
[Not yet recruiting]
Waterbury, Connecticut, United States, 06708
United States, Florida
Jacksonville Center for Clinical Research
[Recruiting]
Jacksonville, Florida, United States, 32216
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
[Recruiting]
Lake Mary, Florida, United States, 32746
United States, Georgia
Clinical Research Atlanta, headlands LLC
[Not yet recruiting]
Stockbridge, Georgia, United States, 30281
United States, Kansas
Johnson County Clin-Trials, Inc. (JCCT)
[Not yet recruiting]
Lenexa, Kansas, United States, 66219
United States, Maryland
Centennial Medical Group
[Not yet recruiting]
Elkridge, Maryland, United States, 21075
Advanced Primary and Geriatric Care
[Not yet recruiting]
Rockville, Maryland, United States, 20850
United States, Massachusetts
DM Clinical Research - Brookline
[Not yet recruiting]
Brookline, Massachusetts, United States, 02445
United States, Minnesota
Clinical Research Institute, Inc.
[Not yet recruiting]
Minneapolis, Minnesota, United States, 55402
United States, Nebraska
Velocity Clinical Research Providence
[Not yet recruiting]
Omaha, Nebraska, United States, 68134
United States, New Hampshire
ActivMed Research LLC
[Not yet recruiting]
Portsmouth, New Hampshire, United States, 03801
United States, New York
Rochester Clinical Research, Inc.
[Not yet recruiting]
Rochester, New York, United States, 14609
United States, Oklahoma
Lynn Health Science Institute
[Not yet recruiting]
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Hatboro Medical Associates/CCT Research
[Not yet recruiting]
Hatboro, Pennsylvania, United States, 19040
United States, Rhode Island
Velocity Clinical Research Providence
[Not yet recruiting]
East Greenwich, Rhode Island, United States, 02818
United States, Texas
Benchmark Research
[Not yet recruiting]
Fort Worth, Texas, United States, 76135
DM Clinical Research
[Recruiting]
Tomball, Texas, United States, 77375
United States, Virginia
Charlottesville Medical Research Center, LLC
[Not yet recruiting]
Charlottesville, Virginia, United States, 22911
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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