UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043340 |
|---|---|
| Receipt number | R000049480 |
| Scientific Title | Research for acquired immunity according to COVID-19 vaccination |
| Date of disclosure of the study information | 2021/02/16 |
| Last modified on | 2023/02/17 12:35:55 |
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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
600
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
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
uwamino@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2030 | 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, adverse reactions
Management information
Registered date
| 2021 | Year | 02 | Month | 16 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049480
