Status:
RECRUITING
First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
Lead Sponsor:
Clover Biopharmaceuticals AUS Pty
Conditions:
Respiratory Syncytial Virus Vaccination
Human Metapneumovirus Vaccination
Eligibility:
All Genders
65-80 years
Phase:
PHASE1
Brief Summary
This phase 1 study will evaluate the safety, reactogenicity, and immunogenicity of 3 different dose levels of SCB-1022 and SCB-1033 in healthy adults aged 60-85 years.
Detailed Description
The study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06984094
Start Date
June 18 2025
End Date
June 30 2026
Last Update
August 8 2025
Active Locations (1)
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1
Fusion Clinical Research
Adelaide, Southern Australia, Australia, 5067