NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedHealthy Subject
Date of first enrollment2021/09/02
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Blood sampling

Outcome(s)

Primary OutcomeSARS-CoV-2 neutralizing antibody titer Anti-spike protein IgG antibody titer Cellular immunity (cytokine-producing cell count)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. 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

Contact

public contact
Name Yohei Seki
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan Japan 541-0045
Telephone 06-6202-2161
E-mail 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
E-mail Shokuiki_antibody@shionogi.co.jp
Affiliation Shionogi & Co., Ltd. Drug Development and Regulatory Science Division