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

Not Applicable

• Conditions: Healthy Subject

• Registration Number: JPRN-UMIN000045492
• Lead Sponsor: Shionogi & Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Study Completion: 2022-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

Not provided

Exclusion Criteria

1. Participants who have been confirmed to have a history of SARS-CoV-2 infection. 2. A loss of > 200 mL of whole blood or blood components within 12 weeks or > 100 mL within 4 weeks of the first dose of study intervention in male participants. A loss of > 200 mL of whole blood or blood components within 16 weeks or > 100 mL within 4 weeks of the first dose of study intervention in female participants. 3. Current enrollment or past participation within the last 30 days before signing of ICF in any other clinical study involving an clinical study or any other type of medical research. 4. Participants who have been confirmed to be positive in human immunodeficiency virus (HIV) antigen/antibody test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody test result.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 neutralizing antibody titer Anti-spike protein IgG antibody titer Cellular immunity (cytokine-producing cell count)