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

• ClinicalTrials.gov Identifier: NCT05992935
• Recruitment Status: Recruiting
• First Posted: August 15, 2023
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Norovirus Acute Gastroenteritis	Biological: mRNA-1403; Biological: mRNA-1405; Biological: Placebo	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: August 25, 2023
• Estimated Primary Completion Date: May 7, 2025
• Estimated Study Completion Date: May 7, 2025

Arms and Interventions

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: mRNA-1403; Sterile liquid for injection; Biological: Placebo; 0.9% sodium chloride (normal saline) 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: mRNA-1405; Sterile liquid for injection; Biological: Placebo; 0.9% sodium chloride (normal saline) 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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to a maximum of Day 36 (7 days after last study injection) ]
2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to a maximum of Day 57 (28 days after last study injection) ]
3. Number of Participants with Medically Attended AEs (MAAEs) [ Time Frame: Day 1 up to a maximum of Day 197 ]
4. 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) [ Time Frame: Day 1 up to a maximum of Day 365 ]

Secondary Outcome Measures :

1. Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes [ Time Frame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1 and 29 ]
2. Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers [ Time Frame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1 and 29 ]
3. Percentage of Participants with Seroresponse Based on HBGA Blocking Antibody Titers [ Time Frame: Phase 1: Days 29, and 57; Phase 2: Day 29 ]
4. Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes [ Time Frame: Days 1, 29, and 57 ]
5. GMFR of bAb Levels [ Time Frame: Days 1, 29, and 57 ]
6. Percentage of Participants with Seroresponse Based on bAb Levels [ Time Frame: Days 29 and 57 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Moderna Clinical Trials Support Center; 1-877-777-7187; clinicaltrials@modernatx.com

Locations

United States, California

ARK Clinical Research, LLC; Recruiting

Long Beach, California, United States, 90815

United States, Colorado

Tekton Research, Inc - Longmont Center; Recruiting

Longmont, Colorado, United States, 80501

United States, Florida

Research Centers of America; Recruiting

Hollywood, Florida, United States, 33024

United States, Georgia

Accel Research Sites Network; Recruiting

Decatur, Georgia, United States, 30030

United States, Illinois

Optimal Research; Recruiting

Peoria, Illinois, United States, 61614

United States, Indiana

Velocity Clinical Research - Boise; Recruiting

Meridian Hills, Indiana, United States, 83642

United States, Iowa

Meridian Clinical Research, LLC; Recruiting

Sioux City, Iowa, United States, 51106

United States, Kansas

Johnson County Clin-Trials (JCCT); Recruiting

Lenexa, Kansas, United States, 66219

United States, Maryland

Rockville Internal Medicine Group; Recruiting

Rockville, Maryland, United States, 20854

United States, Nebraska

Meridian Clinical Research, LLC; Recruiting

Norfolk, Nebraska, United States, 68701

Velocity Clinical Research; Recruiting

Omaha, Nebraska, United States, 68134

United States, New York

Rochester Clinical Research, Inc; Recruiting

Rochester, New York, United States, 14609

United States, Texas

C & R Research Services USA / HHBA Health LLC; Withdrawn

Houston, Texas, United States, 77054

Epic Medical Research, LLC; Recruiting

Red Oak, Texas, United States, 75154

United States, Utah

JBR Clinical Research; Recruiting

Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

ModernaTX, Inc.

More Information

• Responsible Party: ModernaTX, Inc.
• ClinicalTrials.gov Identifier: NCT05992935
• Other Study ID Numbers: mRNA-1403/1405-P101
• First Posted: August 15, 2023
• Last Update Posted: April 29, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ModernaTX, Inc.:

mRNA-1403; mRNA-1405; Norovirus

Additional relevant MeSH terms:

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases