A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
NCT ID: NCT06067230
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1153 participants
INTERVENTIONAL
2023-10-06
2026-07-30
Brief Summary
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Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Part B is non-randomized.
PREVENTION
QUADRUPLE
Study Groups
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Part A: mRNA-1345 Dose 1
Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.
mRNA-1345
Sterile liquid for injection
Part A: mRNA-1345 Dose 2
Single injection of mRNA-1345 administered IM on Day 1.
mRNA-1345
Sterile liquid for injection
Part B: mRNA-1345 Dose 2
Two injections of mRNA-1345 administered IM on Day 1 and Day 57.
mRNA-1345
Sterile liquid for injection
Interventions
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mRNA-1345
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* Adults ≥18 to \<60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
1. Coronary artery disease and/or congestive heart failure.
2. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
3. Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.
Part B:
* Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
* Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
Parts A and B:
\- Able to comply with study requirements.
Exclusion Criteria
* Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary.
* History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
* Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1.
* History of myocarditis, pericarditis, or myopericarditis.
Part B:
* Previous treatment with alemtuzumab or rituximab within 2 years prior to Day 1.
* Previous treatment with plasmapheresis within 30 days prior to Day 1.
* A history of complications of immunosuppression.
* A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment.
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Lenzmeier Family Medicine - CCT - PPDS
Glendale, Arizona, United States
Foothills Research Center - CCT - PPDS
Phoenix, Arizona, United States
Fiel Family & Sports Medicine - PC - CCT - PPDS
Tempe, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
San Diego, California, United States
Critical Care, Pulmonary and Sleep Associates / CCT Research
Lakewood, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Excel Medical Clinical Trials DBA Flourish
Boca Raton, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
CenExel RCA - Hollywood
Hollywood, Florida, United States
Clinical Research Atlanta - Headlands - PPDS
Stockbridge, Georgia, United States
Snake River Research, PLLC
Idaho Falls, Idaho, United States
University of Chicago
Chicago, Illinois, United States
AES - DRS - Optimal Research Illinois - Peoria
Peoria, Illinois, United States
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana, United States
Velocity Clinical Research (Rockville - Maryland) - PPDS
Rockville, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
DM Clinical Research - Southfield - ERN - PPDS
Southfield, Michigan, United States
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
Lincoln, Nebraska, United States
University of Rochester - Rochester General Hospital - PPDS
Rochester, New York, United States
Montefiore Medical Center - BRANY - PPDS
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
DM Clinical Research - Philadelphia - ERN - PPDS
Philadelphia, Pennsylvania, United States
Benchmark Research - Fort Worth - HyperCore - PPDS
Fort Worth, Texas, United States
DM Clinical Research - Cyfair Clinical Research Center
Houston, Texas, United States
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo, Texas, United States
DM Clinical Research - ERN - PPDS
Tomball, Texas, United States
Springville Dermatology - CCT - PPDS
Springville, Utah, United States
Velocity Clinical Research - Hampton - PPDS
Hampton, Virginia, United States
Centricity Research Suffolk Family Medicine
Suffolk, Virginia, United States
Velocity Clinical Research - Family Practice - Suffolk - PPDS
Suffolk, Virginia, United States
University of Alberta
Edmonton, Alberta, Canada
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, Canada
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Colchester Research Group
Truro, Nova Scotia, Canada
Diex Recherche - Sherbrooke - PPDS
Sherbrooke, Quebec, Canada
Diex Recherche - Québec - PPDS
Québec, , Canada
Caribbean Medical Research Center
San Juan, , Puerto Rico
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom
Fylde Coast Clinical Research
Blackpool, Lancashire, United Kingdom
Liverpool School of Tropical Medicine
Liverpool, Merseyside, United Kingdom
Aberdeen Royal Infirmary - PPDS
Aberdeen, , United Kingdom
The Royal Free Hospital
London, , United Kingdom
Countries
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References
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Mayer EF, Falsey AR, Clark R, Ferguson M, Cardona J, She F, Jones B, Reuter C, Collins A, Mannan A, Kapoor A, Slobod K, Stoszek SK, Du J, Mou J, Lan L, Zhou H, Wilson E, Goswami J, Das R, Priddy F. Safety, Tolerability, and Immunogenicity of mRNA-1345 in Adults at Increased Risk for RSV Disease Aged 18 to 59 Years. Clin Infect Dis. 2025 Jun 4:ciaf292. doi: 10.1093/cid/ciaf292. Online ahead of print.
Other Identifiers
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mRNA-1345-P303
Identifier Type: -
Identifier Source: org_study_id
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