Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
Clover Biopharmaceuticals USA, LLC · NCT06843317
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 60–85 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 160
- US sites recruiting
- 5
- Study start
- March 21, 2025
- Record last updated
- May 14, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Candidate vaccine, SCB-1019T; AREXVY; placebo
Conditions: RSV Infection
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Recruiting US locations
AMR Phoenix
Phoenix, AZ 85282
Site contact: William Reedy, MD · 615-591-0211 · amrteam@amrllc.com
AMR Fort Myers
Fort Myers, FL 33912
Site contact: Pedro Ylisastigui, MD · 615-591-0211 · amrteam@amrllc.com
AMR Lexington
Lexington, KY 40509
Site contact: Mark Adams, MD · 615-591-0211 · amrteam@amrllc.com
AMR Kansas City
Kansas City, MO 64114
Site contact: Martha Sue Fanning, MD · 615-591-0211 · amrteam@amrllc.com
Knoxville
Knoxville, TN 37909
Site contact: Jerry B. Punch, MD · 615-591-0211 · amrteam@amrllc.com
Study contacts (from the official record)
- Xuesong Pei, MD · (+86) 18515445890 · xuesong.pei@cloverbiopharma.com
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