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

NCT06067230 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: mRNA-1345-P303
• Study Type: interventional
• Target: 1,153
• Locations: 4 countries
• Sites: 44

Brief Summary

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

Conditions

Respiratory Syncytial Virus

Keywords

Viral Diseases; Messenger RNA; Moderna; mRNA-1345; Respiratory syncytial virus; Safety; Vaccines; Immunocompromised; Organ transplant

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B

• Number of Participants with Unsolicited Adverse Events (AEs)

  Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B

• Number of Participants With Medically Attended AEs (MAAEs)

  Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)

• Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation

  Day 1 through End of Study (Day 730)

• Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29

  Day 29

• Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85

  Day 85

Secondary Outcomes (21)

• Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29

  Day 29

• Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs

  Up to End of Study (Day 730)

• Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs

  Up to End of Study (Day 730)

• Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels

  Baseline up to Day 730

• Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs

  Up to End of Study (Day 730)

Study Arms (3)

Part A: mRNA-1345 Dose 1

EXPERIMENTAL

Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.

Biological: mRNA-1345

Part A: mRNA-1345 Dose 2

EXPERIMENTAL

Single injection of mRNA-1345 administered IM on Day 1.

Biological: mRNA-1345

Part B: mRNA-1345 Dose 2

EXPERIMENTAL

Two injections of mRNA-1345 administered IM on Day 1 and Day 57.

Biological: mRNA-1345

Interventions

mRNA-1345 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1345 Dose 1; Part A: mRNA-1345 Dose 2; Part B: mRNA-1345 Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Part A:
• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (44)

Lenzmeier Family Medicine - CCT - PPDS

Glendale, Arizona, 85308-5093, United States

Location

Foothills Research Center - CCT - PPDS

Phoenix, Arizona, 85044-6097, United States

Location

Fiel Family & Sports Medicine - PC - CCT - PPDS

Tempe, Arizona, 85283-1528, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-3075, United States

Location

Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS

San Diego, California, 92103-2209, United States

Location

Critical Care, Pulmonary and Sleep Associates / CCT Research

Lakewood, Colorado, 80228, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510-2483, United States

Location

Excel Medical Clinical Trials DBA Flourish

Boca Raton, Florida, 33434, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012-4170, United States

Location

CenExel RCA - Hollywood

Hollywood, Florida, 33024-2709, United States

Location

Clinical Research Atlanta - Headlands - PPDS

Stockbridge, Georgia, 30281-9054, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404-7573, United States

Location

University of Chicago

Chicago, Illinois, 60637-1443, United States

Location

AES - DRS - Optimal Research Illinois - Peoria

Peoria, Illinois, 61614-4885, United States

Location

Benchmark Research - Covington - HyperCore - PPDS

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research (Rockville - Maryland) - PPDS

Rockville, Maryland, 20854-2960, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2608, United States

Location

DM Clinical Research - Southfield - ERN - PPDS

Southfield, Michigan, 48076-5412, United States

Location

Velocity Clinical Research (Lincoln - Nebraska) - PPDS

Lincoln, Nebraska, 68510, United States

Location

University of Rochester - Rochester General Hospital - PPDS

Rochester, New York, 14621-3011, United States

Location

Montefiore Medical Center - BRANY - PPDS

The Bronx, New York, 10467-2401, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

DM Clinical Research - Philadelphia - ERN - PPDS

Philadelphia, Pennsylvania, 19107-1530, United States

Location

Benchmark Research - Fort Worth - HyperCore - PPDS

Fort Worth, Texas, 76135-5283, United States

Location

DM Clinical Research - Cyfair Clinical Research Center

Houston, Texas, 77065-5685, United States

Location

Benchmark Research - San Angelo - HyperCore - PPDS

San Angelo, Texas, 76904-7610, United States

Location

DM Clinical Research - ERN - PPDS

Tomball, Texas, 77375-6543, United States

Location

Springville Dermatology - CCT - PPDS

Springville, Utah, 84663, United States

Location

Velocity Clinical Research - Hampton - PPDS

Hampton, Virginia, 23666-6262, United States

Location

Centricity Research Suffolk Family Medicine

Suffolk, Virginia, 23435-3763, United States

Location

Velocity Clinical Research - Family Practice - Suffolk - PPDS

Suffolk, Virginia, 23435, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Canadian Center for Vaccinology

Halifax, Nova Scotia, L7 8XZ, Canada

Location

Colchester Research Group

Truro, Nova Scotia, B2N 1L2, Canada

Location

Diex Recherche - Sherbrooke - PPDS

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche - Québec - PPDS

Québec, G1V 4T3, Canada

Location

Caribbean Medical Research Center

San Juan, 00918, Puerto Rico

Location

Royal Devon and Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

Fylde Coast Clinical Research

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

Liverpool School of Tropical Medicine

Liverpool, Merseyside, L7 8XZ, United Kingdom

Location

Aberdeen Royal Infirmary - PPDS

Aberdeen, AB25 2ZD, United Kingdom

Location

The Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40464662 DERIVED

MeSH Terms

Conditions

Virus Diseases

Interventions

mRNA-1345 respiratory syncytial virus vaccine

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A: double-blind Part B: open-label (no masking)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio. Part B is non-randomized.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: October 6, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

GB (5); CA (6); US (32); PR (1)