Overview
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.
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 immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.
Eligibility
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.