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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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06067230
Collaborator
(none)
1,150
Enrollment
48
Locations
3
Arms
26.8
Anticipated Duration (Months)
24
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA-1345
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio. Part B is non-randomized.Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio. Part B is non-randomized.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part A: double-blind Part B: open-label (no masking)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Oct 4, 2023
Anticipated Primary Completion Date :
Dec 29, 2025
Anticipated Study Completion Date :
Dec 29, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: mRNA-1345 Dose 1

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

Biological: mRNA-1345
Sterile liquid for injection
Experimental: Part A: mRNA-1345 Dose 2

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

Biological: mRNA-1345
Sterile liquid for injection
Experimental: Part B: mRNA-1345 Dose 2

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

Biological: mRNA-1345
Sterile liquid for injection

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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)]

  4. 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)]

  5. 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]

  6. Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85 [Day 85]

Secondary Outcome Measures

  1. Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29 [Day 29]

  2. Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29 [Day 29]

  3. Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs [Up to Day 730]

  4. Part A: Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs [Up to Day 730]

  5. Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs up to Day 730 [Up to Day 730]

  6. 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]

  7. Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29 [Day 29]

  8. Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29 [Day 29]

  9. Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85 [Day 85]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lenzmeier Family Medicine - CCT - PPDS Glendale Arizona United States 85308-5093
2 Foothills Research Center - CCT - PPDS Phoenix Arizona United States 85044-6097
3 Fiel Family & Sports Medicine - PC - CCT - PPDS Tempe Arizona United States 85283-1528
4 David Geffen School of Medicine at UCLA Los Angeles California United States 90095-3075
5 Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS San Diego California United States 92103-2209
6 Critical Care, Pulmonary and Sleep Associates / CCT Research Lakewood Colorado United States 80228
7 Yale University School of Medicine - 135 College S New Haven Connecticut United States 06510-2483
8 Indago Research and Health Center Hialeah Florida United States 33012-4170
9 CenExel RCA - Hollywood Hollywood Florida United States 33024-2709
10 Clinical Research Atlanta - Headlands - PPDS Stockbridge Georgia United States 30281-9054
11 Snake River Research, PLLC Idaho Falls Idaho United States 83404-7573
12 Rush University Medical Center -1725 W Harrison St Chicago Illinois United States 60612-3823
13 University of Chicago Chicago Illinois United States 60637-1443
14 AES - DRS - Optimal Research Illinois - Peoria Peoria Illinois United States 61614-4885
15 Benchmark Research - Covington - HyperCore - PPDS Covington Louisiana United States 70433
16 Velocity Clinical Research (Rockville - Maryland) - PPDS Rockville Maryland United States 20854-2960
17 Henry Ford Hospital Detroit Michigan United States 48202-2608
18 DM Clinical Research - Southfield - ERN - PPDS Southfield Michigan United States 48076-5412
19 Velocity Clinical Research (Lincoln - Nebraska) - PPDS Lincoln Nebraska United States 68510
20 Montefiore Medical Center - BRANY - PPDS Bronx New York United States 10467-2401
21 University of Rochester - Rochester General Hospital - PPDS Rochester New York United States 14621-3011
22 Duke University Medical Center - 2301 Erwin Dr Durham North Carolina United States 27710
23 Penn Prevention Clinical Research Site Philadelphia Pennsylvania United States 19104-3309
24 DM Clinical Research - Philadelphia - ERN - PPDS Philadelphia Pennsylvania United States 19107-1530
25 Benchmark Research - Fort Worth - HyperCore - PPDS Fort Worth Texas United States 76135-5283
26 Cyfair Clinical Research Center - ERN - PPDS Houston Texas United States 77065-5685
27 Benchmark Research - San Angelo - HyperCore - PPDS San Angelo Texas United States 76904-7610
28 DM Clinical Research - ERN - PPDS Tomball Texas United States 77375-6543
29 Springville Dermatology - CCT - PPDS Springville Utah United States 84663
30 Velocity Clinical Research - Hampton - PPDS Hampton Virginia United States 23666-6262
31 Velocity Clinical Research - Family Practice - Portsmouth - PPDS Portsmouth Virginia United States 23703-3200
32 David Ramstad Associates Research - Centricity Research - HyperCore - PPDS Suffolk Virginia United States 23435-3763
33 University of Alberta Edmonton Alberta Canada T6G 2G3
34 Okanagan Clinical Trials - Headlands - PPDS Kelowna British Columbia Canada V1Y 1Z9
35 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1
36 Canadian Center for Vaccinology Halifax Nova Scotia Canada B3K 6R8
37 Colchester Research Group Truro Nova Scotia Canada B2N 1L2
38 Humber River Hospital Toronto Ontario Canada M3M 0B2
39 University Health Network - 585 University Ave Toronto Ontario Canada M5G 2N2
40 Centricity Research - Quebec - HyperCore - PPDS Levis Quebec Canada G6W 0M5
41 Diex Recherche - Sherbrooke - PPDS Sherbrooke Quebec Canada J1L 0H8
42 Diex Recherche - Québec - PPDS Quebec Canada G1V 4T3
43 Caribbean Medical Research Center San Juan Puerto Rico 918
44 Royal Devon and Exeter Hospital (Wonford) - Barrack Rd Exeter Devon United Kingdom EX2 5DW
45 Layton Medical Centre Blackpool Lancashire United Kingdom FY3 7EN
46 Liverpool School of Tropical Medicine Liverpool Merseyside United Kingdom L3 5QA
47 Aberdeen Royal Infirmary - PPDS Aberdeen United Kingdom AB25 2ZA
48 The Royal Free Hospital London United Kingdom NW3 2QG

Sponsors and Collaborators

  • ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ModernaTX, Inc.
ClinicalTrials.gov Identifier:
NCT06067230
Other Study ID Numbers:
  • mRNA-1345-P303
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ModernaTX, Inc.
Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
Safety
Vaccines
Immunocompromised
Organ transplant
Additional relevant MeSH terms:
Virus Diseases

Study Results

No Results Posted as of Oct 4, 2023