UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048537 |
|---|---|
| Receipt number | R000055299 |
| Scientific Title | Studies on the relationship between antibody titer due to vaccination with novel coronavirus vaccine, and blood PBMC activity and dietary habits |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2023/06/30 11:04:03 |
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Basic information
Public title
Studies on the relationship between antibody titer due to vaccination with novel coronavirus vaccine, and blood PBMC activity and dietary habits
Acronym
Studies on the relationship between antibody titer due to vaccination with novel coronavirus vaccine, and blood PBMC activity and dietary habits
Scientific Title
Studies on the relationship between antibody titer due to vaccination with novel coronavirus vaccine, and blood PBMC activity and dietary habits
Scientific Title:Acronym
Studies on the relationship between antibody titer due to vaccination with novel coronavirus vaccine, and blood PBMC activity and dietary habits
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring factors related to individual differences in vaccination efficacy against novel coronaviruses
Basic objectives2
Others
Basic objectives -Others
Relationship
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between PBMC activity and the results of SARS-CoV-2 infection test
Key secondary outcomes
- Relationship between PBMC activity and frequency of yogurt intake
- Relationship between PBMC activity and intestinal microbiota
- Relationship between frequency of yogurt intake and intestinal microbiota
- Relationship between frequency of yogurt intake and the results of SARS-CoV-2 infection test
- Relationship between the intestinal microbiota and the results of SARS-CoV-2 infection test
- Relationship between the trend of SARS-CoV-2 infection test results and the trend of PBMC activity
- Relationship between the trend of SARS-CoV-2 infection test results and intestinal microbiota
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are participating in the "Kanagawa ME-BYO Cohort Study" and have valid responses to the questionnaire regarding the frequency of yogurt consumption.
(2) Persons who are participating in the "Citywide monitoring of COVID-19 using the genome cohort" and have been tested for SARS-CoV-2 infection.
(3) Persons who have been fully informed about the study, are able to understand its contents, and are able to give their written consent.
Key exclusion criteria
(1) Persons with a history or current history of autoimmune or other immune-related diseases
(2) Persons who are pregnant
(3) Persons who have contracted an infectious disease during the period from 30 days prior to the date of obtaining consent
(4) Persons who have donated 200 mL of blood in one month before start of the study
(5) Males who have donated 400 mL of blood within 3 months before start of the study
(6) Females who have donated 400 mL of blood within 4 months before start of the study
(7) Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL
(8) Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL
(9) Persons who are judged by the investigator or sub-investigator to be inappropriate to participate in this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Co., Ltd.
Division name
Basic Microbiology Research Department Food Microbiology and Function Research Laboratories R&D Div.
Zip code
1920919
Address
1-19-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
+81-42-632-5838
Homepage URL
none@none
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.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
| 2022 | Year | 08 | Month | 01 | 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
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | 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
Exploring factors related to individual differences in vaccination efficacy against novel coronaviruses
Management information
Registered date
| 2022 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055299
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
