UMIN-CTR Clinical Trial

Basic information
Public title	Research for acquired immunity according to COVID-19 vaccination
Acronym	Research for COVID-19 vaccine immunity
Scientific Title	Research for acquired immunity according to COVID-19 vaccination
Scientific Title:Acronym	Research for COVID-19 vaccine immunity
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess acquisition rate and duration of cellular and humoral immunity after COVID-19 vaccination
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	acquisition rate of cellular and humoral immunity for SARS-CoV-2
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Faculty stuffs and hospital stuffs of Keio University Shinanomachi campus Vaccinated or planned to be vaccinated for COVID-19 vaccine Capable for informed consent and blood collection
Key exclusion criteria	Minors Contraindicated for vaccination
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Masatoshi Middle name Last name Wakui
Organization	Keio University School of Medicine
Division name	Department of Laboratory Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	wakuism@keio.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Uwamino
Organization	Keio University School of Medicine
Division name	Department of Laboratory Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	uwamino@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 01 Month 14 Day
Date of IRB	2021 Year 02 Month 08 Day
Anticipated trial start date	2021 Year 02 Month 16 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Design: Prospective Exposure- COVID-19 Vaccination Outcome- Humoral and Cellular immunity for SARS-CoV-2 Observation:Antibody titer and T cell and B cell immune response to SARS-CoV-2

Management information
Registered date	2021 Year 02 Month 16 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049480

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.