Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
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
160 participants
Mar 21, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
- Individuals willing and able to give an informed consent, prior to screening.
- 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 defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).
Exclusion Criteria5
- Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
- Recurrent or un-controlled neurological disorders or seizures.
- Serious or unstable chronic illnesses
- Any history of dementia or any medical condition that moderately or severely impairs cognition
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
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Interventions
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
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06843317