UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047028 |
|---|---|
| Receipt number | R000053654 |
| Scientific Title | Correlation between saliva IgG neutralizing antibodies and blood IgG neutralizing antibodies after vaccination against SARS-CoV-2 |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/03/01 09:49:31 |
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Basic information
Public title
Investigation of saliva IgG neutralizing antibodies after vaccination against SARS-CoV-2
Acronym
Saliva IgG and blood IgG against after SARS-CoV-2 vaccination
Scientific Title
Correlation between saliva IgG neutralizing antibodies and blood IgG neutralizing antibodies after vaccination against SARS-CoV-2
Scientific Title:Acronym
Correlation between saliva IgG and blood IgG neutralizing antibodies after SARS-CoV-2 vaccination
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After vaccination against SARS-CoV-2, neutralizing antibodies are produced, but their evaluation is done using blood. However, since the pandemic, many people have become interested in the antibody titer, but the blood test cannot be used for self-care and does not meet the demand. (2) Objective: To determine whether neutralizing IgG antibodies increase in blood after vaccination against new coronaviruses and whether they also increase in saliva.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determine whether neutralizing IgG antibodies increase in blood, but also correlate and increase in saliva. Correlation coefficients of 7 or higher will be used as outcome measures.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Specimens will be collected before the third dose of vaccine against SARS-CoV-2 and 3 weeks after the third dose of vaccine.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who are scheduled to receive three doses of vaccine
Key exclusion criteria
Subjects who have been infected with the SARS-CoV-2 infection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82 Inaoka, Yokosuka, Kanagawa
TEL
+81468228866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82 Inaoka, Yokosuka, Kanagawa
TEL
+81468228866
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
82 Inaoka, Yokosuka, Kanagawa
Tel
+81468228866
tsukinoki@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
| 2022 | Year | 03 | 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
45
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
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | 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
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053654
