Revaccination with SCB-1019T vaccine in older adults

A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before

This study is testing a new vaccine called SCB-1019T to see if it can boost immunity in healthy adults aged 60-85 who have already received the AREXVY vaccine.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Clover Biopharmaceuticals, Ltd (Industry-sponsored)
• Locations: 5 sites (Phoenix, Arizona and 4 other locations)
• Trial ID: NCT06843317 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 60-85 who have previously been vaccinated with AREXVY.

Not a fit: Patients who are not within the specified age range or have not received the AREXVY vaccine will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance immunity against RSV in older adults, potentially reducing the incidence of RSV infections.

How similar studies have performed: Other studies have shown promise in revaccination strategies for enhancing immunity, making this approach potentially beneficial but still under evaluation.

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.

Where this trial is running

Phoenix, Arizona and 4 other locations

• 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

Conditions RSV Infection