A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults
Respiratory Syncytial Virus

About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus focused on measuring Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines, Immunocompromised, Organ transplant
Eligibility Criteria
Key Inclusion Criteria: Part A: 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: Coronary artery disease and/or congestive heart failure. Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma). 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. Key Exclusion Criteria: Part A: 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. Note: Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Lenzmeier Family Medicine - CCT - PPDS
- Foothills Research Center - CCT - PPDS
- Fiel Family & Sports Medicine - PC - CCT - PPDS
- David Geffen School of Medicine at UCLA
- Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
- Critical Care, Pulmonary and Sleep Associates / CCT Research
- Yale University School of Medicine - 135 College S
- Indago Research and Health Center
- CenExel RCA - Hollywood
- Clinical Research Atlanta - Headlands - PPDS
- Snake River Research, PLLC
- Rush University Medical Center -1725 W Harrison St
- University of Chicago
- AES - DRS - Optimal Research Illinois - Peoria
- Benchmark Research - Covington - HyperCore - PPDS
- Velocity Clinical Research (Rockville - Maryland) - PPDS
- Henry Ford Hospital
- DM Clinical Research - Southfield - ERN - PPDS
- Velocity Clinical Research (Lincoln - Nebraska) - PPDS
- Montefiore Medical Center - BRANY - PPDS
- University of Rochester - Rochester General Hospital - PPDS
- Duke University Medical Center - 2301 Erwin Dr
- Penn Prevention Clinical Research Site
- DM Clinical Research - Philadelphia - ERN - PPDS
- Benchmark Research - Fort Worth - HyperCore - PPDS
- Cyfair Clinical Research Center - ERN - PPDS
- Benchmark Research - San Angelo - HyperCore - PPDS
- DM Clinical Research - ERN - PPDS
- Springville Dermatology - CCT - PPDS
- Velocity Clinical Research - Hampton - PPDS
- Velocity Clinical Research - Family Practice - Portsmouth - PPDS
- David Ramstad Associates Research - Centricity Research - HyperCore - PPDS
- University of Alberta
- Okanagan Clinical Trials - Headlands - PPDS
- Vancouver General Hospital
- Canadian Center for Vaccinology
- Colchester Research Group
- Humber River Hospital
- University Health Network - 585 University Ave
- Centricity Research - Quebec - HyperCore - PPDS
- Diex Recherche - Sherbrooke - PPDS
- Diex Recherche - Québec - PPDS
- Caribbean Medical Research Center
- Royal Devon and Exeter Hospital (Wonford) - Barrack Rd
- Layton Medical Centre
- Liverpool School of Tropical Medicine
- Aberdeen Royal Infirmary - PPDS
- The Royal Free Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part A: mRNA-1345 Dose 1
Part A: mRNA-1345 Dose 2
Part B: mRNA-1345 Dose 2
Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.
Single injection of mRNA-1345 administered IM on Day 1.
Two injections of mRNA-1345 administered IM on Day 1 and Day 57.