Revaccination with SCB-1019T vaccine in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and immunogenicity of the SCB-1019T vaccine for revaccination in healthy adults aged 60-85 who have previously received the AREXVY vaccine. Participants will be assigned to receive either the SCB-1019T vaccine, a homologous revaccination with AREXVY, or a placebo. The study is designed to assess the tolerability and immune response generated by the SCB-1019T vaccine compared to the existing vaccine and placebo. A safety monitoring committee will oversee the study to ensure participant safety throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• AMR Phoenix
  Phoenix, Arizona, United States Recruiting
• AMR Fort Myers
  Fort Myers, Florida, United States Recruiting
• AMR Lexington
  Lexington, Kentucky, United States Recruiting
• AMR Kansas City
  Kansas City, Missouri, United States Recruiting
• Knoxville
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Xuesong Pei, MD
• Email: xuesong.pei@cloverbiopharma.com
• Phone: (+86) 18515445890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.