NCT06843317 · Clover Biopharmaceuticals USA, LLC
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Fort Myers, Florida
- Lexington, Kentucky
- Kansas City, Missouri
- Knoxville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2025 · Source of record for eligibility and locations