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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048537
Receipt No. 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 2022/08/01

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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
Email 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
Email none@none

Sponsor
Institute Metagen, Inc.
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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