Examination of stratification of subjects based on SARS-CoV-2 S-IgG antibody levels before and after vaccination with the new corona vaccine using the compact immunoassay device IA-100

JRCT ID: jRCT1032230148

Registered date:16/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Confirmation of antibody titers before and after vaccination with the new coronavirus
• Date of first enrollment: 05/06/2023
• Target sample size: 160
• Study type: Interventional
• Intervention(s): For this clinical study, blood collection will be performed.

Outcome(s)

• Primary Outcome: Whether subjects can be stratified based on the amount of SARS-CoV-2 S-IgG antibodies before and after COVID-19 vaccination
• Secondary Outcome: Examination of whether there is an association between stratified subject groups and vaccine type, whether they were infected with the new coronavirus before the booster vaccination, age, gender, and whether they were infected after the booster vaccination.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Persons who are able to obtain written consent from the person himself/herself or a representative (including family members, relatives, and adult guardians) and who do not meet all of the following gratitude criteria

Exclude criteria

A facility resident who was judged by the attending physician to be inappropriate for this study.
Institutional residents under the age of 65.
Institutional residents with a history of bleeding disorders.
Institutional residents with a history of vagal reflexes.
Facility residents who do not wish to be vaccinated against COVID-19 during their stay in the facility

Related Information

• Primary Sponsor: Haruo Ozaki
• Secondary Sponsor: Junya Inoue,Sysmex Corporation