A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before
Clover Biopharmaceuticals USA, LLC
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.
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
- Age range
- 60–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before. 2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. 3. Individuals willing and able to give an informed consent, prior to screening. 4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is def…
Interventions
- BiologicalCandidate vaccine, SCB-1019T
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™.
- BiologicalAREXVY
positive comparator
- Otherplacebo
Placebo Comparator
Locations (5)
- AMR PhoenixPhoenix, Arizona
- AMR Fort MyersFort Myers, Florida
- AMR LexingtonLexington, Kentucky
- AMR Kansas CityKansas City, Missouri
- KnoxvilleKnoxville, Tennessee