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
Overview
- Phase
- Phase 1
- Intervention
- mRNA-1403
- Conditions
- Norovirus Acute Gastroenteritis
- Sponsor
- ModernaTX, Inc.
- Enrollment
- 1405
- Locations
- 16
- Primary Endpoint
- Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
- Status
- Recruiting
- Last Updated
- last month
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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
- •Part B Phase 2 booster extension period: acute disease or febrile 72 hours prior to or on Day
- •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.
Arms & Interventions
Phase 2 Part B: mRNA-1403 Dose Level 3
Participants 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.
Intervention: mRNA-1403
Phase 1 Part A: mRNA-1403 Dose Level 1
Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1.
Intervention: mRNA-1403
Phase 1 Part A: mRNA-1403 Dose Level 2
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2.
Intervention: mRNA-1403
Phase 1 Part A: mRNA-1403 Dose Level 3
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3.
Intervention: mRNA-1403
Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1
Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4.
Intervention: mRNA-1403
Phase 1 Part A: 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-matching placebo.
Intervention: mRNA-1403
Phase 1 Part A: 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-matching placebo.
Intervention: Placebo
Phase 1 Part A: mRNA-1405 Dose Level 1
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1.
Intervention: mRNA-1405
Phase 1 Part A: mRNA-1405 Dose Level 2
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2.
Intervention: mRNA-1405
Phase 1 Part A: mRNA-1405 Dose Level 3
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3.
Intervention: mRNA-1405
Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4.
Intervention: mRNA-1405
Phase 1 Part A: 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-matching placebo.
Intervention: mRNA-1405
Phase 1 Part A: 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-matching placebo.
Intervention: Placebo
Phase 1 Part A: Placebo
Participants will receive 2 IM injections of study vaccine-matching placebo.
Intervention: Placebo
Phase 2 Part B: mRNA-1403 Dose Level 1
Participants will receive 1 IM injection of mRNA-1403 at Dose Level 1.
Intervention: mRNA-1403
Phase 2 Part B: mRNA-1403 Dose Level 2
Participants 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.
Intervention: mRNA-1403
Phase 2 Part B: mRNA-1403 Dose Level 2
Participants 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.
Intervention: Placebo
Phase 2 Part B: mRNA-1403 Dose Level 3
Participants 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.
Intervention: Placebo
Phase 2 Part B: Placebo
Participants will receive 1 IM injection of study vaccine-matching placebo.
Intervention: Placebo
Phase 2 Part C: mRNA-1403 Dose Level 3
Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3.
Intervention: mRNA-1403
Phase 2 Part C: Placebo
Participants will receive 1 IM injection of study vaccine-matching placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame: Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to a maximum of Day 57 (28 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
Time Frame: 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)
Time Frame: Day 1 up to a maximum of Day 730
Secondary Outcomes
- Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes(Days 1, 29, and 57)
- Percentage of Participants with Seroresponse Based on bAb Levels(Days 29 and 57)
- 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)
- GMFR of bAb Levels(Days 29 and 57)