First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults

Launched by CLOVER BIOPHARMACEUTICALS AUS PTY · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is a first-of-its-kind study that aims to test the safety and immune response of two new vaccines, SCB-1022 and SCB-1033, designed to protect against respiratory syncytial virus (RSV) infections in healthy older adults aged 60 to 85 years. The study will look at three different doses of these vaccines to see how well they work and whether they cause any side effects. The trial is not currently recruiting participants, but it will focus on ensuring that the vaccines are safe and effective for older adults.

To be eligible for this study, participants must be between 60 and 85 years old and generally healthy, meaning they can have stable medical conditions but should not be experiencing any serious health issues. They should also be willing to attend all study visits and provide consent to participate. During the trial, participants can expect to receive vaccinations and undergo various health assessments to monitor their response to the vaccines. It's important to know that individuals who are pregnant, have certain neurological conditions, or are experiencing acute illnesses will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female participants 60 to 85 years of age at the screening visit.
• • Individuals 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.
• • Please refer to Protocol for full list of Inclusion and Exclusion criteria.
• Exclusion Criteria:
• • Pregnancy or potential to become pregnant during the study.
• • Acute disease or fever (≥38°C) at time of vaccination.
• • History of Guillain-Barré Syndrome (GBS).
• • Recurrent or un-controlled neurological disorders or seizures.
• • Serious or unstable chronic illnesses. Please refer to Protocol for full list of Inclusion and Exclusion criteria.