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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.
positive comparator
Placebo Comparator
AMR Phoenix
Phoenix, Arizona, United States
RECRUITINGAMR Fort Myers
Fort Myers, Florida, United States
RECRUITINGAMR Lexington
Lexington, Kentucky, United States
RECRUITINGTo evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with local and systemic solicited AEs
Time frame: Within 7 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with unsolicited AEs
Time frame: Within 28 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Time frame: Throughout the study period, from enrollment to 6 months follow up
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AMR Kansas City
Kansas City, Missouri, United States
RECRUITINGKnoxville
Knoxville, Tennessee, United States
RECRUITING