Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults
Status: Active_not_recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to \<50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
• Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the screening visit.
Locations
United States
Florida
CenExel
Hollywood
Georgia
Meridian Clinical Research
Savannah
Iowa
Meridian Clinical Research
Sioux City
Kansas
Johnson County Clinical Trials
Lenexa
Nebraska
Meridian Clinical Research
Lincoln
Texas
Benchmark Research
Austin
Tekton Research, Inc
Austin
DM Clinical Research- Texas Center for Drug Development
Houston
Time Frame
Start Date: 2022-05-24
Completion Date: 2026-02-21
Participants
Target number of participants: 308
Treatments
Experimental: Part 1: mRNA-1345
Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
Experimental: Part 1: mRNA-1647 2-Dose
Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.
Experimental: Part 1: mRNA-1647 3-Dose
Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
Experimental: Part 2: mRNA-1273
Participants will receive single IM injection of mRNA-1273 on Day 1
Experimental: Part 2: mRNA-1010
Participants will receive single IM injection of mRNA-1010 on Day 1.
Active_comparator: Part 2: FLUAD®
Participants will receive single IM injection of FLUAD® on Day 1.
Related Therapeutic Areas
Sponsors
Leads: ModernaTX, Inc.