Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: RSV Infection
In brief
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.
Key facts
- Study ID
- NCT06843317
- Run by
- Clover Biopharmaceuticals USA, LLC
- People needed
- 160
- Starts
- 2025-03-21
- Expected to finish
- 2026-06-03
- Last updated by the study team
- 2025-05-14
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
You may not qualify if…
- 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.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Where it is running
- AMR Phoenix — Phoenix, Arizona, United States (enrolling)
- AMR Fort Myers — Fort Myers, Florida, United States (enrolling)
- AMR Lexington — Lexington, Kentucky, United States (enrolling)
- AMR Kansas City — Kansas City, Missouri, United States (enrolling)
- Knoxville — Knoxville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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