UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046320 |
|---|---|
| Receipt number | R000052818 |
| Scientific Title | Investigation for T-cell mediated response to SARS-CoV-2 S peptide after SARS-CoV-2 vaccination |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2023/12/11 11:34:14 |
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Basic information
Public title
Investigation for T-cell mediated response to SARS-CoV-2 S peptide after SARS-CoV-2 vaccination
Acronym
Investigation for T-cell mediated response to SARS-CoV-2 S peptide after SARS-CoV-2 vaccination
Scientific Title
Investigation for T-cell mediated response to SARS-CoV-2 S peptide after SARS-CoV-2 vaccination
Scientific Title:Acronym
Investigation for T-cell mediated response to SARS-CoV-2 S peptide after SARS-CoV-2 vaccination
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the activation of SARS-CoV-2 S peptide specific T cell responses after the third dose of COVID-19 vaccination (BNT162b2) using the clinical immunology laboratory by a whole blood Interferon-Gamma Release (IGRA) immuno Assay.
Basic objectives2
Others
Basic objectives -Others
To compare the change between IGRA assay and the antibody response after the third dose of BNT162b2.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of interferon gamma production to SARS-CoV-2 S peptide after the third dose of COVID-19 vaccination.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Employees of Fukuoka City Hospital who have undergone interferon gamma releasing assay to assess the T-cell response to SARS-CoV-2 vaccination.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Tani |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Medicine and Biosystemic Science
Zip code
812-8582
Address
Fukuoka Japan, 3-1-1, Maidashi, Higashi-ku Fukuoka-shi, Fukuoka
TEL
+81-92-642-5229
tani.kyushu.univ@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tani |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Medicine and Biosystemic Science
Zip code
812-8582
Address
Fukuoka Japan, 3-1-1, Maidashi, Higashi-ku Fukuoka-shi, Fukuoka
TEL
+81-92-642-5229
Homepage URL
tani.kyushu.univ@gmail.com
Sponsor or person
Institute
Fukuoka City Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Fukuoka City Hospital
Address
13-1, Yoshizukahonmachi, Hakata-ward, Fukuoka-city, Fukuoka 812-0046 JAPAN
Tel
+81-92-801-1011
rinshou@adm.fukuoka-u.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 | 12 | Month | 13 | 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
281
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 23 | Day |
Other
Other related information
The observation of the change of T-cell responses to SARS-CoV-2 S peptides after the third dose of SARS-CoV-2 vaccination.
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052818
