COVID-19
Conditions
Interventions
Blood sampling
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who are vaccinated against SARS-CoV-2 (Participation to this study from the 2nd vaccination is permitted.) 2. Those who consented to this study and signed in the ICF. 3. Those who have no comorbidity of HIV infection or hepatitis b/c, and those who were confirmed by medical interview that they were not carriers of HIV, HBV and HBV.
Exclusion criteria
Exclusion criteria: 1. For male, those who more than 200 mL of their whole blood or blood component has been lost within 12 weeks before consent acquisition, or those who more than 100 mL of their whole blood or blood component has been lost within 4 weeks before consent acquisition. For female, those who more than 200 mL of their whole blood or blood component has been lost within 16 weeks before consent acquisition, or those who more than 100 mL of their whole blood or blood component has been lost within 4 weeks before consent acquisition. 2. Those who participated in other clinical studies within 30 days before consent acquisition, or are participating in other clinical studies except for "Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination" conducted by Shionogi & Co., Ltd.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody titer for virus neutralization activity | — |
Secondary
| Measure | Time frame |
|---|---|
| - IgG antibody titer to SARS-CoV-2 spike protein - Cell-mediated immunity (Number of cell producing cytokines) - Th1/Th2 balance - SARS-CoV-2 infection | — |
Countries
Japan
Contacts
Public ContactShintaro Tanaka
Shionogi & Co., Ltd. Medical Affairs Department
Outcome results
None listed