UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the immunogenicity and durability of second COVID-19 vaccine booster dose and their associations with the background factors
Acronym	Investigation of the immunogenicity and durability of second COVID-19 vaccine booster dose and their associations with the background factors
Scientific Title	Investigation of the immunogenicity and durability of second COVID-19 vaccine booster dose and their associations with the background factors
Scientific Title:Acronym	Investigation of the immunogenicity and durability of second COVID-19 vaccine booster dose and their associations with the background factors
Region	Japan

Condition
Condition	Regardless of the type of disease
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) to assess the kinetics of immune response to second COVID-19 vaccine booster dose among residents of long-term care facilities and outpatients and its durability during 24 weeks after the second booster dose, 2) to assess the associations among clinical background factors and vaccine immunogenicity and its durability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of immune response between residents of long-term care facilities and outpatients at four weeks and 24 weeks after the second COVID-19 vaccine booster dose.
Key secondary outcomes	The assessment of associations vaccine immunogenicity at four weeks and 24 weeks after the second COVID-19 vaccine booster dose with the clinical background of participants.

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	1) those who receive the second COVID-19 vaccine booster dose. 2) patients who visit or are admitted to or undergoing a home visit from Hofu Rehabilitation Hospital. 3) Persons who have received sufficient explanation regarding participation in this study with voluntary written consent provided by the person or their guardians after sufficient understanding.
Key exclusion criteria	1) Those who do not wish to be vaccinated with second COVID-19 vaccine booster dose. 2) Those who are judged to be inappropriate for registration at the discretion of the doctor in charge.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Kakugawa
Organization	Graduate School of Medicine, Yamaguchi University
Division name	Department of Pulmonology and Gerontology
Zip code	755-8505
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2196
Email	kakugawa@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Kakugawa
Organization	Graduate School of Medicine, Yamaguchi University
Division name	Department of Pulmonology and Gerontology
Zip code	755-8505
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2196
Homepage URL
Email	kakugawa@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Pulmonology and Gerontology, Graduate School of Medicine, Yamaguchi University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Respiratory Medicine and Infectious Disease, Yamaguchi University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center For Clinical Research, Yamaguchi University Hospital
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel	0836-22-2428
Email	me223@yamaguchi-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	2022 Year 07 Month 20 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	2022 Year 06 Month 07 Day
Date of IRB	2022 Year 06 Month 22 Day
Anticipated trial start date	2022 Year 07 Month 20 Day
Last follow-up date	2027 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1) Humoral and cellular immune response will be evaluated using frozen serum or plasma samples before, four weeks, and 24 weeks after the second COVID-19 vaccine booster dose. 2) For those who participated in the previous study [Background factors affecting the effectiveness of the COVID-19 vaccine and their association with the microbiomes in the oral cavity and intestinal tract (UMIN000043558)], the data already obtained in the above previous study will be used in this study in order to investigate the kinetics of humoral and cellular immune response over time after the first COVID-19 vaccination and its associations with the background factors and microbiomes. 3) If the fifth COVID-19 vaccine dose is to be started within 24 weeks after the second COVID-19 vaccine booster dose, blood collection at 24 weeks will be done before the fifth COVID-19 vaccine dose. 4) If it is difficult to collect blood samples before the second COVID-19 vaccine booster dose, it will be skipped. Those that are skipped will be processed as missing values during statistical analysis.

Management information
Registered date	2022 Year 07 Month 18 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055137