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RecruitingAccepts healthy volunteersPhase 1

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

Clover Biopharmaceuticals USA, LLC · NCT06843317

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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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Safety and Immunogenicity Study of Revaccination With SCB-1019T in… (NCT06843317) | Bored Studies