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

Primary Purpose

Respiratory Syncytial Virus

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
mRNA-1345
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: mRNA-1345 Dose 1

Part A: mRNA-1345 Dose 2

Part B: mRNA-1345 Dose 2

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants With Medically Attended AEs (MAAEs)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
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
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85

Secondary Outcome Measures

Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Part A: Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs up to Day 730
Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers up to Day 730
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06067230
Brief Title
A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, 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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 4, 2023 (Anticipated)
Primary Completion Date
December 29, 2025 (Anticipated)
Study Completion Date
December 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines, Immunocompromised, Organ transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio. Part B is non-randomized.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Part A: double-blind Part B: open-label (no masking)
Allocation
Randomized
Enrollment
1150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: mRNA-1345 Dose 1
Arm Type
Experimental
Arm Description
Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.
Arm Title
Part A: mRNA-1345 Dose 2
Arm Type
Experimental
Arm Description
Single injection of mRNA-1345 administered IM on Day 1.
Arm Title
Part B: mRNA-1345 Dose 2
Arm Type
Experimental
Arm Description
Two injections of mRNA-1345 administered IM on Day 1 and Day 57.
Intervention Type
Biological
Intervention Name(s)
mRNA-1345
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
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
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
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
Title
Number of Participants With Medically Attended AEs (MAAEs)
Time Frame
Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
Title
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Time Frame
Day 1 through End of Study (Day 730)
Title
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
Time Frame
Day 29
Title
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Time Frame
Day 85
Secondary Outcome Measure Information:
Title
Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
Time Frame
Day 29
Title
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Time Frame
Day 29
Title
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Time Frame
Up to Day 730
Title
Part A: Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Time Frame
Up to Day 730
Title
Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs up to Day 730
Time Frame
Up to Day 730
Title
Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers up to Day 730
Time Frame
Up to Day 730
Title
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Time Frame
Day 29
Title
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
Time Frame
Day 29
Title
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85
Time Frame
Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
Lenzmeier Family Medicine - CCT - PPDS
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308-5093
Country
United States
Facility Name
Foothills Research Center - CCT - PPDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044-6097
Country
United States
Facility Name
Fiel Family & Sports Medicine - PC - CCT - PPDS
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283-1528
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-3075
Country
United States
Facility Name
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
City
San Diego
State/Province
California
ZIP/Postal Code
92103-2209
Country
United States
Facility Name
Critical Care, Pulmonary and Sleep Associates / CCT Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Yale University School of Medicine - 135 College S
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-2483
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-4170
Country
United States
Facility Name
CenExel RCA - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024-2709
Country
United States
Facility Name
Clinical Research Atlanta - Headlands - PPDS
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281-9054
Country
United States
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7573
Country
United States
Facility Name
Rush University Medical Center -1725 W Harrison St
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3823
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
AES - DRS - Optimal Research Illinois - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614-4885
Country
United States
Facility Name
Benchmark Research - Covington - HyperCore - PPDS
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Velocity Clinical Research (Rockville - Maryland) - PPDS
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854-2960
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
DM Clinical Research - Southfield - ERN - PPDS
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076-5412
Country
United States
Facility Name
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Montefiore Medical Center - BRANY - PPDS
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2401
Country
United States
Facility Name
University of Rochester - Rochester General Hospital - PPDS
City
Rochester
State/Province
New York
ZIP/Postal Code
14621-3011
Country
United States
Facility Name
Duke University Medical Center - 2301 Erwin Dr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Penn Prevention Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3309
Country
United States
Facility Name
DM Clinical Research - Philadelphia - ERN - PPDS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-1530
Country
United States
Facility Name
Benchmark Research - Fort Worth - HyperCore - PPDS
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135-5283
Country
United States
Facility Name
Cyfair Clinical Research Center - ERN - PPDS
City
Houston
State/Province
Texas
ZIP/Postal Code
77065-5685
Country
United States
Facility Name
Benchmark Research - San Angelo - HyperCore - PPDS
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904-7610
Country
United States
Facility Name
DM Clinical Research - ERN - PPDS
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375-6543
Country
United States
Facility Name
Springville Dermatology - CCT - PPDS
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
Velocity Clinical Research - Hampton - PPDS
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666-6262
Country
United States
Facility Name
Velocity Clinical Research - Family Practice - Portsmouth - PPDS
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23703-3200
Country
United States
Facility Name
David Ramstad Associates Research - Centricity Research - HyperCore - PPDS
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435-3763
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Okanagan Clinical Trials - Headlands - PPDS
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1
Country
Canada
Facility Name
Canadian Center for Vaccinology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Colchester Research Group
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
University Health Network - 585 University Ave
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Centricity Research - Quebec - HyperCore - PPDS
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Diex Recherche - Sherbrooke - PPDS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Diex Recherche - Québec - PPDS
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Facility Name
Caribbean Medical Research Center
City
San Juan
ZIP/Postal Code
918
Country
Puerto Rico
Facility Name
Royal Devon and Exeter Hospital (Wonford) - Barrack Rd
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Layton Medical Centre
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Liverpool School of Tropical Medicine
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L3 5QA
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary - PPDS
City
Aberdeen
ZIP/Postal Code
AB25 2ZA
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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