UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043589 |
|---|---|
| Receipt number | R000049773 |
| Scientific Title | Immunogenicity and safety COVID-19 vaccine in healthy adults: a single institute based cohort study |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/08/28 16:43:54 |
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Basic information
Public title
Immunogenicity and safety COVID-19 vaccine in healthy adults: a single institute based cohort study
Acronym
Immunogenicity and safety COVID-19 vaccine in healthy adults: a single institute based cohort study
Scientific Title
Immunogenicity and safety COVID-19 vaccine in healthy adults: a single institute based cohort study
Scientific Title:Acronym
Immunogenicity and safety of COVID-19 vaccine in healthy adults
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the factors that influence on immunogenicity and safety of COVID vaccine in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody
Local reaction
Key secondary outcomes
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Medical Students
Key exclusion criteria
Person who had a history of COVID-19
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Hara |
Organization
Saga University
Division name
Preventive medicine
Zip code
849
Address
Nabeshima 5-1-1, Saga, Japan
TEL
0952-34-2289
harameg@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Hara |
Organization
Saga university
Division name
Preventive medicine
Zip code
849
Address
Nabeshima 5-1-1, Saga, Japan
TEL
0952-34-2289
Homepage URL
harameg@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
MWLH
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee of Saga University.
Address
Nabeshima 5-1-1, Saga, Japan
Tel
0952-34-3400
harameg@cc.saga-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
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-393X/10/7/1035
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2076-393X/10/7/1035
Number of participants that the trial has enrolled
88
Results
ALDH2 mutant with low antibody titer
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
88 Japanese workers and students
Participant flow
Collected applicants for participation on campus
Adverse events
No
Outcome measures
Antibody titer
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two years of follow-up after vaccination
Management information
Registered date
| 2021 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049773
