search
Back to results

Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 49 Years of Age and 60 to 80 Years of Age.

Primary Purpose

Norovirus Acute Gastroenteritis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1403
mRNA-1405
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Norovirus Acute Gastroenteritis focused on measuring mRNA-1403, mRNA-1405, Norovirus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: 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. 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 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.

Sites / Locations

  • ARK Clinical Research, LLCRecruiting
  • Tekton Research, Inc - Longmont CenterRecruiting
  • Research Centers of AmericaRecruiting
  • Accel Research Sites Network
  • Optimal Research
  • Velocity Clinical Research - BoiseRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Johnson County Clin-Trials (JCCT)Recruiting
  • Rockville Internal Medicine GroupRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Rochester Clinical Research, Inc
  • C & R Research Services USA / HHBA Health LLC
  • Epic Medical Research, LLC
  • JBR Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

mRNA-1403 Dose Level 1

mRNA-1403 Dose Level 2

mRNA-1403 Dose Level 3

mRNA-1403 Dose Level 4 Regimen 1

mRNA-1403 Dose Level 4 Regimen 2

mRNA-1405 Dose Level 1

mRNA-1405 Dose Level 2

mRNA-1405 Dose Level 3

mRNA-1405 Dose Level 4 Regimen 1

mRNA-1405 Dose Level 4 Regimen 2

Placebo

Arm Description

Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.

Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.

Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.

Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.

Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.

Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.

Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.

Participants will receive 2 IM injections of study vaccine-matching placebo.

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Medically Attended AEs (MAAEs)
Number of Participants with Any SAEs, AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AESIs

Secondary Outcome Measures

Geometric Mean Titer (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers
Percentage of Participants with Seroresponse Based on HBGA Blocking Antibody Titer
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
GMFR of bAb Titers
Percentage of Participants with Seroresponse Based on bAb Titer

Full Information

First Posted
August 7, 2023
Last Updated
September 14, 2023
Sponsor
ModernaTX, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05992935
Brief Title
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 49 Years of Age and 60 to 80 Years of Age.
Official Title
A Phase 1, 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 49 Years of Age and 60 to 80 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
January 21, 2025 (Anticipated)
Study Completion Date
May 21, 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 purpose 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norovirus Acute Gastroenteritis
Keywords
mRNA-1403, mRNA-1405, Norovirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1403 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.
Arm Title
mRNA-1403 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.
Arm Title
mRNA-1403 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.
Arm Title
mRNA-1403 Dose Level 4 Regimen 1
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.
Arm Title
mRNA-1403 Dose Level 4 Regimen 2
Arm Type
Experimental
Arm Description
Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.
Arm Title
mRNA-1405 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.
Arm Title
mRNA-1405 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.
Arm Title
mRNA-1405 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.
Arm Title
mRNA-1405 Dose Level 4 Regimen 1
Arm Type
Experimental
Arm Description
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.
Arm Title
mRNA-1405 Dose Level 4 Regimen 2
Arm Type
Experimental
Arm Description
Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matched placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive 2 IM injections of study vaccine-matching placebo.
Intervention Type
Biological
Intervention Name(s)
mRNA-1403
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1405
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 7 after each study intervention
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to 28 days after each vaccination
Title
Number of Participants with Medically Attended AEs (MAAEs)
Time Frame
Day 1 through 6 months after last study intervention (Day 169)
Title
Number of Participants with Any SAEs, AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AESIs
Time Frame
Day 1 to end-of study (Day 365)
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Time Frame
Days 1, 29, and 57
Title
Geometric Mean Fold Rise (GMFR) of HBGA Blocking Antibodies Titers
Time Frame
Days 1, 29, and 57
Title
Percentage of Participants with Seroresponse Based on HBGA Blocking Antibody Titer
Time Frame
Days 29 and 57
Title
GMT of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Time Frame
Days 1, 29, and 57
Title
GMFR of bAb Titers
Time Frame
Days 1, 29, and 57
Title
Percentage of Participants with Seroresponse Based on bAb Titer
Time Frame
Days 29 and 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: 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. 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 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.
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
ARK Clinical Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research, Inc - Longmont Center
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites Network
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research - Boise
City
Meridian Hills
State/Province
Indiana
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Individual Site Status
Recruiting
Facility Name
Johnson County Clin-Trials (JCCT)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Recruiting
Facility Name
Rockville Internal Medicine Group
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
C & R Research Services USA / HHBA Health LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Epic Medical Research, LLC
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 49 Years of Age and 60 to 80 Years of Age.

We'll reach out to this number within 24 hrs