UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048434 |
|---|---|
| Receipt number | R000055190 |
| Scientific Title | Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers used for evaluation of COVID-19 nasal vaccine |
| Date of disclosure of the study information | 2022/07/23 |
| Last modified on | 2023/04/05 14:37:23 |
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Basic information
Public title
Establishment of anti-novel coronavirus antibody titer measurement method in nasal washes and saliva
Acronym
Antibody titer in nasal washes and saliva
Scientific Title
Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers used for evaluation of COVID-19 nasal vaccine
Scientific Title:Acronym
Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers
Region
| Japan |
Condition
Condition
Coronavirus disease (COVID-19)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish a system for measuring specific antibody titers against SARS-CoV-2 spike protein in the upper respiratory tract specimens (nasal washes, saliva, exhaled breath) and to investigate the relationship between each measured value and the gene polymorphism of mucosal immunology-related genes should be investigated
Basic objectives2
Others
Basic objectives -Others
Bioanalysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Z-Score(Numerical value representing the accuracy of the assay system calculated from data variability and signal intensity)
Key secondary outcomes
S/B (Numerical value representing the accuracy of the assay system calculated as ratio of signal value to background value)
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
| Behavior,custom |
Interventions/Control_1
Prescribe two hospital visits, and collect blood, upper respiratory tract specimens, and saliva for each visit.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Cohort A: Those who are expected to exert mucosal immunity and meet the following conditions (1) and (2)]
(1) Has a history of SARS-CoV-2 positive judgment
(2) COVID-19 mRNA vaccine has been inoculated after SARS-CoV-2 infection, and it is within 90 days of vaccination at the time of consent acquisition.
[Cohort B: Those who are expected not to exert mucosal immunity and meet the following conditions (1) and (2)]
(1) No history of SARS-CoV-2 infection (including suspected infection)
(2) No history of COVID-19 vaccination, or more than 180 days have passed since COVID-19 vaccination at the time of consent acquisition.
[Common to Cohort A, B]
Those who have received sufficient explanation in participating in this research, and who have obtained the voluntary written consent of the research subject after sufficient understanding.
Key exclusion criteria
[Cohort A: Those who are expected to exert mucosal immunity and meet the following conditions (1) and (2)]
(1) Has a history of SARS-CoV-2 positive judgment
(2) COVID-19 mRNA vaccine has been inoculated after SARS-CoV-2 infection, and it is within 90 days of vaccination at the time of consent acquisition.
[Cohort B: Those who are expected not to exert mucosal immunity and meet the following conditions (1) and (2)]
(1) No history of SARS-CoV-2 infection (including suspected infection)
(2) No history of COVID-19 vaccination, or more than 180 days have passed since COVID-19 vaccination at the time of consent acquisition.
[Common to Cohort A, B]
Those who have received sufficient explanation in participating in this research, and who have obtained the voluntary written consent of the research subject after sufficient understanding.
[Standards common to cohorts A and B]
1) Those who have not passed 14 days since the onset of SARS-CoV-2
2) Those who have an otolaryngology disease (however, pollinosis in the non-scattering period is not excluded) and are judged to be ineligible by the principal investigator or the research coordinator.
3) Those who have periodontal disease and are judged to be ineligible by the principal investigator or the research coordinator.
4) Pregnant women
5) Others who are judged to be ineligible by the principal investigator or the research coordinator
It was
[Criteria for Cohort A only]
6) Those who are receiving steroids (excluding external preparations) or immunosuppressants
7) Persons suffering from diseases associated with immunosuppression such as acquired immunodeficiency syndrome
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kohtaro |
| Middle name | |
| Last name | Fujihashi |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccinology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677 Japan
TEL
043-222-7171
kfujihashi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Nagira |
Organization
Chiba University Hospital
Division name
Department of Human Mucosal Vaccinology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8677 Japan
TEL
043-222-7171
Homepage URL
morio.nagira@shionogi.co.jp
Sponsor or person
Institute
Chiba University Hospital
Department of Human Mucosal Vaccinology
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NATIONAL INSTITUTE OF INFECTIOUS DISEASE
Name of secondary funder(s)
Shionogi Co. Ltd.
IRB Contact (For public release)
Organization
Chiba University Hospital Bioethics Review Board
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chib 260-8677 Japa
Tel
043-222-7171
hsp-seimei@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-003-00
Org. issuing International ID_1
Ethics Committee on Human Tissue and Genome Research of Shionogi
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院(千葉県） Chiba University Hospital（Chiba)
国立感染症研究所（東京都） NATIONAL INSTITUTE OF INFECTIOUS DISEASE (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 23 | 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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 08 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055190
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