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

Launched by CLOVER BIOPHARMACEUTICALS USA, LLC · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new vaccine called SCB-1019T, which is designed for older adults who have already received a vaccine called AREXVY for RSV (Respiratory Syncytial Virus) infection. The main goals of the study are to assess how safe the SCB-1019T vaccine is, how well it is tolerated, and how effectively it helps the body build protection against RSV. This study is important because it could help improve vaccination strategies for older adults, who are at higher risk for severe RSV infections.

To be eligible for this trial, participants need to be between 60 and 85 years old, have received the AREXVY vaccine before, and be in generally good health. This means they should not have any serious or unstable health issues and should be able to attend all scheduled visits and procedures. Participants will receive the new vaccine and will be monitored for any side effects and how well their immune system responds to it. It’s important to note that those with certain medical conditions, such as uncontrolled neurological disorders or severe allergies to vaccines, will not be able to participate. Overall, this trial offers a chance to help advance RSV vaccination efforts for older adults.

Gender

ALL

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.