Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
Start Date
3/21/2025
Completion Date
6/3/2026
Summary
CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.
Detailed Description
The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.
Eligibility Criteria
Age Range: 60 years to 85 years
Interventions
Candidate vaccine, SCB-1019T
AREXVY
placebo
Conditions
Locations
AMR Phoenix
Phoenix, Arizona 85282
United States
AMR Fort Myers
Fort Myers, Florida 33912
United States
AMR Lexington
Lexington, Kentucky 40509
United States
AMR Kansas City
Kansas City, Missouri 64114
United States
Knoxville
Knoxville, Tennessee 37909
United States