UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043769 |
|---|---|
| Receipt number | R000049963 |
| Scientific Title | Research on vaccination against SARS-CoV-2 and cross-saliva antibody |
| Date of disclosure of the study information | 2021/03/30 |
| Last modified on | 2022/02/28 13:37:49 |
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Basic information
Public title
Research on vaccination against SARS-CoV-2 and cross-saliva antibody
Acronym
Vaccination against SARS-CoV-2 and cross-saliva antibody
Scientific Title
Research on vaccination against SARS-CoV-2 and cross-saliva antibody
Scientific Title:Acronym
Vaccination against SARS-CoV-2 and cross-saliva antibody
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Dental medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated the positive rate of sIgA, IgG, and IgM in saliva that crosses the SARS-CoV-2 S protein in saliva after vaccination with SARS-CoV-2, and clarified whether there is an affect after vaccination.
Basic objectives2
Others
Basic objectives -Others
This study reveals whether post-vaccine antibody titers can be measured in saliva.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specimen search items, saliva S protein-specific sIgA, saliva S protein-specific IgG, S protein-specific IgM in saliva is measured by ELISA. The search method is as follows: (1) Perform a PCR test to detect SARS-CoV-2 in all search subjects and confirm that it is negative. Next, (2) collect saliva with saliva. Search before, 1 month and 6 months after vaccination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Before and after vaccination against the new coronavirus
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
| 24 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were vaccinated against SARS-CoV-2, and 20 positive and 20 negative SARS-CoV-2 cross-reactive IgA were selected from Kanagawa Dental University Hospital workers in a previous study.
Key exclusion criteria
History of new coronavirus
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
Graduate school of Dentistry
Zip code
2388580
Address
82, Inaoka, Yokosuka city, Kanagawa, Japan
TEL
0468228866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
Graduate school of Dentistry
Zip code
2388580
Address
Inaoka, Yokosuka city, Kanagawa, Japan
TEL
0468228866
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KDU IRB
Address
Inaoka, Yokosuka city, Kanagawa, Japan
Tel
0468251500
graduate@kdu.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 | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
180
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 28 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049963
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
