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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05975099
Recruitment Status : Active, not recruiting
First Posted : August 3, 2023
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 807 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 : July 26, 2023
Estimated Primary Completion Date : March 12, 2026
Estimated Study Completion Date : March 12, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975099


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05975099    
Other Study ID Numbers: mRNA-1975/1982-P101
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: December 21, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1975
mRNA-1982
Vaccine
 Lyme Disease Vaccine
Messenger RNA
Moderna
Additional relevant MeSH terms:
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Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Borrelia Infections
Spirochaetales Infections
Tick-Borne Diseases
Vector Borne Diseases