UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048396 |
|---|---|
| Receipt number | R000055137 |
| Scientific Title | Investigation of the immunogenicity and durability of second COVID-19 vaccine booster dose and their associations with the background factors |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/10/25 17:03:45 |
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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
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
kakugawa@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Pulmonology and Gerontology, Graduate School of Medicine, Yamaguchi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055137
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| Registered date | File name |
| Research case data | |
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