JRCT ID: jRCT1051210161
Registered date:23/01/2022
Immune response after two doses of COVID-19 vaccination
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Coronavirus Disease 2019 |
Date of first enrollment | 24/01/2022 |
Target sample size | 600 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Humoral immune response: changes in antibody titer against SARS-CoV2-Spike protein |
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Secondary Outcome | (1) Humoral immune response: changes in neutralizing antibody titer against SARS-CoV2 (2) Vaccine effectiveness against laboratory-confirmed COVID-19 (including PCR positive, antigen-testing positive, and serological infection) (3) Vaccine effectiveness against COVID-19-like diseases (4) Occurrence of adverse reactions after vaccination (5) Occurrence of diseases suspected to be caused by vaccination [Exploratory outcome(s)] (1) Cell-mediated immunity: SARS-CoV-2 S antigen-specific T cell and B cell function (2) Antibody subclasses |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Those who meet all of the following 1) to 6) 1) Persons who meet any of the following (a), (b) and (c) (a) Participants of "Prospective cohort study of effectiveness and safety of COVID-19 vaccines in Osaka, Japan" * (b) Staff of Osaka City (Metropolitan) University Hospital (c) Faculty / Students of Osaka City (Metropolitan) University School of Medicine / Graduate School of Medicine * Approval number by Osaka City (Metropolitan) University Hospital Certified Review Board: OCU010E, jRCT registration number: jRCT105120014 2) Aged 20 years or older 3) Those who have received two doses of COVID-19 vaccines 4) Those who have passed 5 months since the second dose of COVID-19 vaccines 5) Those who are expected to be able to provide their blood in a predefined number of times during the study period 6) Persons who have voluntarily provided written informed consent for participation |
Exclude criteria | Persons who meet any of the following 1) 2) 1) Those who have received pre-licensure COVID-19 vaccines in the past (e.g., participation in clinical trials before licensure) 2) Those who are judged to be ineligible for research by the principal investigator or the investigator |
Related Information
Primary Sponsor | Kayeka Hiroshi |
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Secondary Sponsor | Hirota Yoshio,Fukushima Wakaba |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Wakaba Fukushima |
Address | 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan Osaka Japan 545-8585 |
Telephone | +81-6-6645-3756 |
wakaba@omu.ac.jp | |
Affiliation | Osaka Metropolitan University |
Scientific contact | |
Name | Hiroshi Kayeka |
Address | 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan Osaka Japan 545-8585 |
Telephone | +81-6-6645-3784 |
kakeya@omu.ac.jp | |
Affiliation | Osaka Metropolitan University |