UMIN ID: UMIN000045492
Registered date:16/09/2021
Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Basic Information
Recruitment status | Complete: follow-up continuing |
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Health condition(s) or Problem(s) studied | Healthy Subject |
Date of first enrollment | 2021/09/02 |
Target sample size | 120 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Blood sampling |
Outcome(s)
Primary Outcome | SARS-CoV-2 neutralizing antibody titer Anti-spike protein IgG antibody titer Cellular immunity (cytokine-producing cell count) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | Shionogi & Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Shionogi & Co., Ltd. |
Secondary ID(s) |
Contact
public contact | |
Name | Yohei Seki |
Address | 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan Japan 541-0045 |
Telephone | 06-6202-2161 |
Shokuiki_antibody@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. Clinical Research Department |
scientific contact | |
Name | Toshinobu Iwasaki |
Address | 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan Japan |
Telephone | 06-6202-2161 |
Shokuiki_antibody@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. Drug Development and Regulatory Science Division |