UMIN-CTR Clinical Trial

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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