Prospective study on evaluation of immunological response after SARS-CoV-2 vaccinatio

Not Applicable

• Conditions: COVID-19

• Registration Number: JPRN-UMIN000045097
• Lead Sponsor: Shionogi & Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-09
• Study Completion: 2022-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody titer for virus neutralization activity

Secondary Outcome Measures

Name	Time	Method
- IgG antibody titer to SARS-CoV-2 spike protein - Cell-mediated immunity (Number of cell producing cytokines) - Th1/Th2 balance - SARS-CoV-2 infection