Prevention of COVID-19 COVID-19 vaccine, self
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older who are healthy at the time of obtaining informed consent. Adults aged 18 years or older with confirmed HIV infection at the time of obtaining informed consent. 2. Participants with a history of COVID-19 infection must have a confirmed date of infection, and at least one month must have elapsed since the most recent episode. 3. Participants who have previously received a COVID-19 vaccine, with at least six months having passed since their most recent vaccination. 4. Participants who are able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals presenting with a clear fever at the time of vaccination ( generally defined as a body temperature over 37.5 degrees). 2. Individuals with a severe acute illness. 3. Individuals who developed febrile upper respiratory tract infection within one month prior to vaccination. 4. Individuals with a history of severe hypersensitivity to any component of the study vaccine. 5. Individuals deemed inappropriate for vaccination based on the precautions or contraindications stated in the package insert of the study vaccine. 6. Any other individuals judged by the principal investigator or subinvestigator to be unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 Neutralizing Antibody (XEC,LP8.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Other Additional Immune Responses | — |
Contacts
IMSUT Hospital, The Institute of Medical Science, The Univers ity of Tokyo