Clinical trial NCT05992935: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Norovirus Acute Gastroenteritis
Keywords: mRNA-1403
mRNA-1405
Norovirus
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 1285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 (relevant only for the base period of Phase 1 and Phase 2).
* 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.
* Phase 2 Part 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.
* Phase 1 Part and Phase 2 Part base period: Any history of myocarditis or pericarditis.
* Phase 2 Part booster extension period: 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 (Phase 2 Part 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 (Phase 2 Part booster extension period only) or plans for receipt during the study.
* Has donated protocol-specified volume of blood products within protocol-specified timeframe.
* Participated or plans to participate in an interventional clinical study within protocol-specified timeframe.
* 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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: Up to a maximum of Day 36 (7 days after each study injection)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to a maximum of Day 57 (28 days after each study injection)
measure: Number of Participants with Medically Attended AEs (MAAEs)
timeFrame: Day 1 up to a maximum of Day 197
measure: 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)
timeFrame: Day 1 up to a maximum of Day 365
Secondary outcomes:
measure: Geometric Mean Titers (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
timeFrame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 365, and 393
measure: Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers
timeFrame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 365, and 393
measure: Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titers
timeFrame: Phase 1: Days 29, and 57; Phase 2: Days 29 and 393
measure: Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
timeFrame: Days 1, 29, and 57
measure: GMFR of bAb Levels
timeFrame: Days 1, 29, and 57
measure: Percentage of Participants with Seroresponse Based on bAb Levels
timeFrame: Days 29 and 57
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: ARK Clinical Research, LLC
state: California
city: Longmont
country: United States
facility: Tekton Research, Inc - Longmont Center
state: Colorado
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Decatur
country: United States
facility: Accel Research Sites Network
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Sioux City
country: United States
facility: Velocity Clinical Research
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials (JCCT)
state: Kansas
city: Rockville
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Norfolk
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Red Oak
country: United States
facility: Epic Medical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: