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

The purpose of the Phase 1 Part 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 the Phase 2 Part of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants 18 to 80 years of age.

Study Overview

• Status: Recruiting
• Conditions: Norovirus Acute Gastroenteritis
• Intervention / Treatment: Biological: Placebo; Biological: mRNA-1403; Biological: mRNA-1405

• Study Type: Interventional
• Enrollment (Estimated): 1260
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Moderna Clinical Trials Support Center; Phone Number: 1-877-777-7187; Email: clinicaltrials@modernatx.com

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90815
      • Recruiting
      • ARK Clinical Research, LLC
  • Colorado
    • Longmont, Colorado, United States, 80501
      • Recruiting
      • Tekton Research, Inc - Longmont Center
  • Florida
    • Hollywood, Florida, United States, 33024
      • Recruiting
      • Research Centers of America
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • Accel Research Sites Network
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Recruiting
      • Optimal Research
  • Indiana
    • Meridian Hills, Indiana, United States, 83642
      • Recruiting
      • Velocity Clinical Research - Boise
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Recruiting
      • Meridian Clinical Research, LLC
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Recruiting
      • Johnson County Clin-Trials (JCCT)
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Recruiting
      • Rockville Internal Medicine Group
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Recruiting
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68134
      • Recruiting
      • Velocity Clinical Research
  • New York
    • Rochester, New York, United States, 14609
      • Recruiting
      • Rochester Clinical Research, Inc
  • Texas
    • Houston, Texas, United States, 77054
      • Withdrawn
      • C & R Research Services USA / HHBA Health LLC
    • Red Oak, Texas, United States, 75154
      • Recruiting
      • Epic Medical Research, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Phase 1 Part: 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.
• Phase 2 Part: 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,

Key Exclusion Criteria:

• Is acutely ill or febrile (temperature ≥38.0°C [100.4°F]) 72 hours prior to or at the Screening Visit or Day 1
• 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, that 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.
• Any history of myocarditis or pericarditis.
• 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 (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 the Screening Visit or plans for receipt during the study.
• Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
• Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.
• Phase 2 Part: Individuals who are participating/have participated in the Phase 1 part of the study are excluded.
• Phase 1 Part: Any individual with laboratory abnormalities achieving thresholds defined in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 Part: mRNA-1403 Dose Level 1; Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.	Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1403 Dose Level 2; Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.	Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1403 Dose Level 3; Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.	Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1403 Dose Level 4 Regimen 1; Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.	Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1403 Dose Level 4 Regimen 2; Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1405 Dose Level 1; Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.	Biological: mRNA-1405; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1405 Dose Level 2; Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.	Biological: mRNA-1405; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1405 Dose Level 3; Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.	Biological: mRNA-1405; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1405 Dose Level 4 Regimen 1; Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.	Biological: mRNA-1405; Sterile liquid for injection
Experimental: Phase 1 Part: mRNA-1405 Dose Level 4 Regimen 2; Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1405; Sterile liquid for injection
Placebo Comparator: Phase 1 Part: Placebo; Participants will receive 2 IM injections of study vaccine-matching placebo.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection
Experimental: Phase 2 Part: mRNA-1403 Dose Level 1; Participants will receive 1 IM injection of mRNA-1403 at Dose Level 1.	Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 2 Part: mRNA-1403 Dose Level 2; Participants will receive 1 IM injection of mRNA-1403 at Dose Level 2.	Biological: mRNA-1403; Sterile liquid for injection
Experimental: Phase 2 Part: mRNA-1403 Dose Level 3; Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3.	Biological: mRNA-1403; Sterile liquid for injection
Placebo Comparator: Phase 2 Part: Placebo; Participants will receive 1 IM injection of study vaccine-matching placebo.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)	Up to a maximum of Day 36 (7 days after last study injection)
Number of Participants with Unsolicited Adverse Events (AEs)	Up to a maximum of Day 57 (28 days after last study injection)
Number of Participants with Medically Attended AEs (MAAEs)	Day 1 up to a maximum of Day 197
Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and Adverse Events of Special Interest (AESIs)	Day 1 up to a maximum of Day 365

Secondary Outcome Measures

Outcome Measure	Time Frame
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 and 29
Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers	Phase 1: Days 1, 29, and 57; Phase 2: Days 1 and 29
Percentage of Participants with Seroresponse Based on HBGA Blocking Antibody Titers	Phase 1: Days 29, and 57; Phase 2: Day 29
Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes	Days 1, 29, and 57
GMFR of bAb Levels	Days 1, 29, and 57
Percentage of Participants with Seroresponse Based on bAb Levels	Days 29 and 57

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): May 7, 2025
• Study Completion (Estimated): May 7, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Norovirus; mRNA-1403; mRNA-1405
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: mRNA-1403/1405-P101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No