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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045492

Enrollment

120

Registered

2021-09-16

Start date

2021-09-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subject

Interventions

Blood sampling

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants who will vaccinate against SARS-CoV-2 2. Participants who signed informed consent. 3. Participants who agreed to participate in "Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination" (UMIN ID:UMIN000045107) conducted by Shionogi & Co., Ltd.

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactYohei Seki

Shionogi & Co., Ltd. Clinical Research Department

Shokuiki_antibody@shionogi.co.jp06-6202-2161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026