NCT06843317 Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
| NCT ID | NCT06843317 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Clover Biopharmaceuticals USA, LLC |
| Condition | RSV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2026-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2025-03-21 with a primary completion date of 2026-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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: 1. 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. 2. Recurrent or un-controlled neurological disorders or seizures. 3. Serious or unstable chronic illnesses 4. Any history of dementia or any medical condition that moderately or severely impairs cognition 5. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06843317 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying RSV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06843317 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06843317 currently recruiting?
Yes, NCT06843317 is actively recruiting participants. Contact the research team at xuesong.pei@cloverbiopharma.com for enrollment information.
Where is the NCT06843317 trial being conducted?
This trial is being conducted at Phoenix, United States, Fort Myers, United States, Lexington, United States, Kansas City, United States and 1 additional location.
Who is sponsoring the NCT06843317 clinical trial?
NCT06843317 is sponsored by Clover Biopharmaceuticals USA, LLC. The trial plans to enroll 160 participants.