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

• ClinicalTrials.gov Identifier: NCT05975099
• Recruitment Status: Active, not recruiting
• First Posted: August 3, 2023
• Last Update Posted: December 21, 2023
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: July 26, 2023
• First Posted Date: August 3, 2023
• Last Update Posted Date: December 21, 2023
• Actual Study Start Date: July 26, 2023
• Estimated Primary Completion Date: March 12, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2023)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 175 (7 days after each study injection) ]
• Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 196 (28 days after each study injection) ]
• Number of Participants With Medically Attended AEs [ Time Frame: 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 [ Time Frame: Day 1 through Day 841 (End of Study) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 26, 2023)

• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Lyme Disease

Intervention

• Biological: mRNA-1975
  Dispersion delivered IM
  Other Name: SR1-7
• Biological: mRNA-1982
  Dispersion delivered IM
  Other Name: SR1
• Biological: Placebo
  Solution delivered IM

Study Arms

• 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.
  Intervention: Biological: mRNA-1975
• 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.
  Intervention: Biological: mRNA-1975
• 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.
  Intervention: Biological: mRNA-1975
• 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.
  Intervention: Biological: mRNA-1975
• 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.
  Intervention: Biological: mRNA-1982
• 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.
  Intervention: Biological: mRNA-1982
• 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.
  Intervention: Biological: mRNA-1982
• Placebo Comparator: Placebo
  Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 20, 2023): 807
• Original Estimated Enrollment (submitted: July 26, 2023): 800
• Estimated Study Completion Date: March 12, 2026
• Estimated Primary Completion Date: March 12, 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05975099
• Other Study ID Numbers: mRNA-1975/1982-P101
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: December 2023