Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
1 other identifier
interventional
1,405
2 countries
16
Brief Summary
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedStudy Start
First participant enrolled
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 22, 2026
March 23, 2026
March 1, 2026
3.1 years
August 7, 2023
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to a maximum of Day 57 (28 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
Day 1 up to a maximum of Day 546
Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study, and Adverse Events of Special Interest (AESIs)
Day 1 up to a maximum of Day 730
Secondary Outcomes (6)
Geometric Mean Titers (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 169, 365, and 393
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers
Phase 1: Days 29, and 57; Phase 2: Days 29, 169, 365, and 393
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titers
Phase 1: Days 29, and 57; Phase 2: Days 29, 169, and 393
Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Days 1, 29, and 57
GMFR of bAb Levels
Days 29 and 57
- +1 more secondary outcomes
Study Arms (17)
Phase 1 Part A: mRNA-1403 Dose Level 1
EXPERIMENTALParticipants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.
Phase 1 Part A: mRNA-1403 Dose Level 2
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1403 at Dose Level 2.
Phase 1 Part A: mRNA-1403 Dose Level 3
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1403 at Dose Level 3.
Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1403 at Dose Level 4.
Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2
EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo.
Phase 1 Part A: mRNA-1405 Dose Level 1
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 1.
Phase 1 Part A: mRNA-1405 Dose Level 2
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 2.
Phase 1 Part A: mRNA-1405 Dose Level 3
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 3.
Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1405 at Dose Level 4.
Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2
EXPERIMENTALParticipants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo.
Phase 1 Part A: Placebo
PLACEBO COMPARATORParticipants will receive 2 IM injections of study vaccine-matching placebo.
Phase 2 Part B: mRNA-1403 Dose Level 1
EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 1.
Phase 2 Part B: mRNA-1403 Dose Level 2
EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 2 and if participating in the booster extension will receive a second dose of study vaccine-matching placebo 12-15 months after first dose.
Phase 2 Part B: mRNA-1403 Dose Level 3
EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 3 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 12-15 months after first dose.
Phase 2 Part B: Placebo
PLACEBO COMPARATORParticipants will receive 1 IM injection of study vaccine-matching placebo.
Phase 2 Part C: mRNA-1403 Dose Level 3
EXPERIMENTALParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 3.
Phase 2 Part C: Placebo
PLACEBO COMPARATORParticipants will receive 1 IM injection of study vaccine-matching placebo.
Interventions
Sterile liquid for injection
Sterile liquid for injection
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
You may qualify if:
- Part A Phase 1: Adults 18 to 49 years of age at the time of consent or adults 60 to 80 years of age at the time of consent.
- Part B Phase 2 and Part C Phase 2: Adults 18 to 80 years of age at the time of consent.
- Body mass index of 18 to 39 kilogram/meter\^2 (inclusive) at the Screening Visit.
- Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest/body feeding.
- A person of childbearing potential is using a highly effective contraceptive method.
- Participant has provided written informed consent for participation in this study.
You may not qualify if:
- Is acutely ill or febrile (temperature ≥38.0°C \[100.4°F\]) 72 hours prior to or at the Screening Visit or Day 1.
- Part B Phase 2 booster extension period: acute disease or febrile 72 hours prior to or on Day 365.
- 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.
- Has a medical, psychiatric, or occupational condition, including reported history of substance abuse, which may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- Has a current or previous diagnosis of immunosuppressive condition, to include human immunodeficiency virus, or immune-mediated (autoimmune) disease that requires immunosuppressive therapies.
- (drugs or biologics). The use of topical corticosteroids or other immunosuppressive agents (for example, topical calcineurin inhibitor) may be eligible for participation at the discretion of the Investigator.
- History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study vaccine.
- Part A Phase 1 and Part B Phase 2 base period: Any history of myocarditis or pericarditis.
- Part B Phase 2 booster extension period and Part C Phase 2: Any history of myocarditis, pericarditis, or Guillain-Barré Syndrome.
- Coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy.
- Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
- Has received systemic immunosuppressive therapies (drugs or biologics) for \>14 days in total within 6 months prior to Screening or Day 365 (Part B Phase 2 booster extension period only) (for corticosteroids ≥10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, intra-articular, and topical steroids are allowed.
- Has received or plans to receive any licensed/authorized vaccine (to include severe acute respiratory syndrome-related coronavirus-2 vaccine) ≤28 days prior to or within 28 days after each study intervention, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study intervention.
- Has received systemic immunoglobulins or blood products within 3 months prior to Screening or Day 365 (Part B Phase 2 booster extension period only) or plans for receipt during the study.
- Has donated protocol-specified volume of blood products within protocol-specified timeframe.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (16)
ARK Clinical Research, LLC
Long Beach, California, 90815, United States
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Accel Research Sites Network
Decatur, Georgia, 30030, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Optimal Research
Peoria, Illinois, 61614, United States
Velocity Clinical Research
Sioux City, Iowa, 51106, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219, United States
Velocity Clinical Research
Rockville, Maryland, 20854, United States
Velocity Clinical Research
Norfolk, Nebraska, 68701, United States
Velocity Clinical Research
Omaha, Nebraska, 68134, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Epic Medical Research, LLC
Red Oak, Texas, 75154, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Emeritus Research Camberwell
Camberwell, Australia
Nucleus Network
Melbourne, Australia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2023
First Posted
August 15, 2023
Study Start
August 25, 2023
Primary Completion (Estimated)
September 22, 2026
Study Completion (Estimated)
September 22, 2026
Last Updated
March 23, 2026
Record last verified: 2026-03