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 Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067230
• Other study ID #: mRNA-1345-P303
• Status: Recruiting
• Phase: Phase 3
• Start date: October 6, 2023
• Est. completion date: December 29, 2025

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: December 29, 2025
• Est. primary completion date: December 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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. 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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Virus Diseases

Intervention

Biological:
• mRNA-1345
Sterile liquid for injection

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Canadian Center for Vaccinology	Halifax	Nova Scotia
Canada	Okanagan Clinical Trials - Headlands - PPDS	Kelowna	British Columbia
Canada	Centricity Research - Quebec - HyperCore - PPDS	Levis	Quebec
Canada	Diex Recherche - Québec - PPDS	Quebec
Canada	Diex Recherche - Sherbrooke - PPDS	Sherbrooke	Quebec
Canada	Humber River Hospital	Toronto	Ontario
Canada	University Health Network - 585 University Ave	Toronto	Ontario
Canada	Colchester Research Group	Truro	Nova Scotia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Puerto Rico	Caribbean Medical Research Center	San Juan
United Kingdom	Aberdeen Royal Infirmary - PPDS	Aberdeen
United Kingdom	Layton Medical Centre	Blackpool	Lancashire
United Kingdom	Royal Devon and Exeter Hospital (Wonford) - Barrack Rd	Exeter	Devon
United Kingdom	Liverpool School of Tropical Medicine	Liverpool	Merseyside
United Kingdom	The Royal Free Hospital	London
United States	Excel Medical Clinical Trials DBA Flourish	Boca Raton	Florida
United States	Montefiore Medical Center - BRANY - PPDS	Bronx	New York
United States	Rush University Medical Center -1725 W Harrison St	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Benchmark Research - Covington - HyperCore - PPDS	Covington	Louisiana
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center - 2301 Erwin Dr	Durham	North Carolina
United States	Benchmark Research - Fort Worth - HyperCore - PPDS	Fort Worth	Texas
United States	Lenzmeier Family Medicine - CCT - PPDS	Glendale	Arizona
United States	Velocity Clinical Research - Hampton - PPDS	Hampton	Virginia
United States	Indago Research and Health Center	Hialeah	Florida
United States	CenExel RCA - Hollywood	Hollywood	Florida
United States	Cyfair Clinical Research Center - ERN - PPDS	Houston	Texas
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	Critical Care, Pulmonary and Sleep Associates / CCT Research	Lakewood	Colorado
United States	Velocity Clinical Research (Lincoln - Nebraska) - PPDS	Lincoln	Nebraska
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	Yale University School of Medicine - 135 College S	New Haven	Connecticut
United States	AES - DRS - Optimal Research Illinois - Peoria	Peoria	Illinois
United States	DM Clinical Research - Philadelphia - ERN - PPDS	Philadelphia	Pennsylvania
United States	Penn Prevention Clinical Research Site	Philadelphia	Pennsylvania
United States	Foothills Research Center - CCT - PPDS	Phoenix	Arizona
United States	Velocity Clinical Research - Family Practice - Portsmouth - PPDS	Portsmouth	Virginia
United States	University of Rochester - Rochester General Hospital - PPDS	Rochester	New York
United States	Velocity Clinical Research (Rockville - Maryland) - PPDS	Rockville	Maryland
United States	Benchmark Research - San Angelo - HyperCore - PPDS	San Angelo	Texas
United States	Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS	San Diego	California
United States	DM Clinical Research - Southfield - ERN - PPDS	Southfield	Michigan
United States	Springville Dermatology - CCT - PPDS	Springville	Utah
United States	Clinical Research Atlanta - Headlands - PPDS	Stockbridge	Georgia
United States	David Ramstad Associates Research - Centricity Research - HyperCore - PPDS	Suffolk	Virginia
United States	Fiel Family & Sports Medicine - PC - CCT - PPDS	Tempe	Arizona
United States	DM Clinical Research - ERN - PPDS	Tomball	Texas
United States	IAA Clinical Research, Inc.	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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
Primary	Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85		Day 85
Secondary	Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29		Day 29
Secondary	Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29		Day 29
Secondary	Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs		Up to Day 730
Secondary	Part A: Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs		Up to Day 730
Secondary	Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs up to Day 730		Up to Day 730
Secondary	Part A: Number of Participants with =2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers up to Day 730		Up to Day 730
Secondary	Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29		Day 29
Secondary	Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29		Day 29
Secondary	Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85		Day 85