A Phase 1, Randomized, Open-label Staggered Dose-escalation and Observer-blind Expansion Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Multicomponent Vaccine mRNA-1365 (Profile 2 [RSV and hMPV]) in Healthy Adults ≥60 Years of Age
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.
- Enrollment
- 375
- Locations
- 10
- Primary Endpoint
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Study Overview
Brief Summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.
- •Body mass index within the range 18.5 to 35 kg/m2 (inclusive).
Exclusion Criteria
- •History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- •Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin >Grade 1, or platelets ≥Grade
- •History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
- •History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- •Participants with immune-mediated (autoimmune) conditions are generally excluded.
- •Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and/or hMPV were administered to participants alone, or as part of a combination vaccine, at any time in the past.
- •Note: Other inclusion and exclusion criteria may apply.
Arms & Interventions
mRNA-1345 (Profile 1)
Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1.
Intervention: mRNA-1345 (Profile 1) (Biological)
mRNA-1345 (Profile 3)
Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1.
Intervention: mRNA-1345 (Profile 3) (Biological)
mRNA-1365 (Profile 2) Dose Level 3
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1.
Intervention: mRNA-1365 (Profile 2) (Biological)
mRNA-1365 (Profile 2) Dose Level 2
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1.
Intervention: mRNA-1365 (Profile 2) (Biological)
mRNA-1365 (Profile 2) Dose Level 1
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1.
Intervention: mRNA-1365 (Profile 2) (Biological)
Outcomes
Primary Outcomes
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
Time Frame: Up to End of Study (EOS) (Day 181)
Secondary Outcomes
- Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)(Day 29)
- Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)(Day 29)
- Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level(Day 29)