Clinical trial 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
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lyme Disease
Keywords: mRNA-1975
mRNA-1982
Vaccine
Lyme Disease Vaccine
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-03
Enrollment: 807
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 175 (7 days after each study injection)
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 196 (28 days after each study injection)
measure: Number of Participants With Medically Attended AEs
timeFrame: Day 1 through Day 337 (6 months after the last study injection)
measure: Number of Participants with AEs of Special Interest, Serious AEs, and AEs Leading to Discontinuation of Study Injection or Study Participation
timeFrame: Day 1 through Day 505 (End of Study)
Secondary outcomes:
measure: Geometric Mean Concentration of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method
timeFrame: Days 1, 29, 85, and 197
measure: Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Concentration at Days 29, 85, and 197 Compared to Day 1 (Baseline)
timeFrame: Days 29, 85, and 197
Other outcomes:
Locations:
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Jacksonville
country: United States
facility: Encore Research Group-Jacksonville Center for Clinical Research
state: Florida
city: Lake Mary
country: United States
facility: University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta, headlands LLC
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc. (JCCT)
state: Kansas
city: Columbia
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Advanced Primary and Geriatric Care
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research - Brookline
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Omaha
country: United States
facility: Meridian Clinical Research - Omaha
state: Nebraska
city: Newington
country: United States
facility: ActivMed Research LLC
state: New Hampshire
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Hatboro
country: United States
facility: Hatboro Medical Associates/CCT Research
state: Pennsylvania
city: Providence
country: United States
facility: Velocity Clinical Research Providence
state: Rhode Island
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
Study officials:
References: