Clinical trial NCT06067230: A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Respiratory Syncytial Virus
Keywords: Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
Safety
Vaccines
Immunocompromised
Organ transplant
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio.

Part B is non-randomized.
Primary purpose: PREVENTION

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).


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:

  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

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: 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
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: 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
measure: Number of Participants With Medically Attended AEs (MAAEs)
timeFrame: Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
timeFrame: Day 1 through End of Study (Day 730)
measure: 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
timeFrame: Day 29
measure: Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
timeFrame: Day 85
Secondary outcomes:
measure: Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
timeFrame: Day 29
measure: Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs
timeFrame: Up to End of Study (Day 730)
measure: Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs
timeFrame: Up to End of Study (Day 730)
measure: Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
timeFrame: Baseline up to Day 730
measure: Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
timeFrame: Up to End of Study (Day 730)
measure: Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
timeFrame: Day 29
measure: Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
timeFrame: Baseline up to Day 730
measure: Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
timeFrame: Baseline up to Day 730
measure: Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs
timeFrame: Up to End of Study (Day 730)
measure: Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers
timeFrame: Up to End of Study (Day 730)
measure: Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
timeFrame: Day 29
measure: Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
timeFrame: Day 29
measure: Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85
timeFrame: Day 85
measure: Part B: GMC of Serum RSV-A and RSV-B Neutralizing Abs
timeFrame: Up to End of Study (Day 730)
measure: Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs
timeFrame: Up to End of Study (Day 730)
measure: Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels
timeFrame: Baseline up to Day 730
measure: Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs
timeFrame: Up to End of Study (Day 730)
measure: Part B: GMC of Serum RSV Pre-F Binding Abs
timeFrame: Up to End of Study (Day 730)
measure: Part B: GMFR of Serum RSV Pre-F Binding Abs
timeFrame: Up to End of Study (Day 730)
measure: Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
timeFrame: Baseline up to End of Study (Day 730)
measure: Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
timeFrame: Up to End of Study (Day 730)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Lenzmeier Family Medicine - CCT - PPDS
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center - CCT - PPDS
state: Arizona
city: Tempe
country: United States
facility: Fiel Family & Sports Medicine - PC - CCT - PPDS
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: San Diego
country: United States
facility: Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
state: California
city: Lakewood
country: United States
facility: Critical Care, Pulmonary and Sleep Associates / CCT Research
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine - 135 College S
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials DBA Flourish
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Hollywood
country: United States
facility: CenExel RCA - Hollywood
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - Headlands - PPDS
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: AES - DRS - Optimal Research Illinois - Peoria
state: Illinois
city: Covington
country: United States
facility: Benchmark Research - Covington - HyperCore - PPDS
state: Louisiana
city: Rockville
country: United States
facility: Velocity Clinical Research (Rockville - Maryland) - PPDS
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research - Southfield - ERN - PPDS
state: Michigan
city: Lincoln
country: United States
facility: Velocity Clinical Research (Lincoln - Nebraska) - PPDS
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center - BRANY - PPDS
state: New York
city: Rochester
country: United States
facility: University of Rochester - Rochester General Hospital - PPDS
state: New York
city: Durham
country: United States
facility: Duke University Medical Center - 2301 Erwin Dr
state: North Carolina
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia - ERN - PPDS
state: Pennsylvania
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth - HyperCore - PPDS
state: Texas
city: Houston
country: United States
facility: Cyfair Clinical Research Center - ERN - PPDS
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo - HyperCore - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN - PPDS
state: Texas
city: Springville
country: United States
facility: Springville Dermatology - CCT - PPDS
state: Utah
city: Hampton
country: United States
facility: Velocity Clinical Research - Hampton - PPDS
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research Suffolk Family Medicine
state: Virginia
city: Suffolk
country: United States
facility: Velocity Clinical Research - Family Practice - Portsmouth - PPDS
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials - Headlands - PPDS
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
city: Truro
country: Canada
facility: Colchester Research Group
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: Diex Recherche - Sherbrooke - PPDS
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche - Québec - PPDS
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford) - Barrack Rd
state: Devon
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
state: Lancashire
city: Liverpool
country: United Kingdom
facility: Liverpool School of Tropical Medicine
state: Merseyside
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - PPDS
city: London
country: United Kingdom
facility: The Royal Free Hospital
Study officials:
References: