UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045550 |
|---|---|
| Receipt number | R000052009 |
| Scientific Title | Elucidation of pathophysiology of allergic reaction by COVID-19 vaccine |
| Date of disclosure of the study information | 2021/09/23 |
| Last modified on | 2022/06/19 14:39:28 |
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Basic information
Public title
Elucidation of pathophysiology of allergic reaction by COVID-19 vaccine
Acronym
Search for the cause of COVID-19 vaccine allergy
Scientific Title
Elucidation of pathophysiology of allergic reaction by COVID-19 vaccine
Scientific Title:Acronym
Search for the cause of COVID-19 vaccine allergy
Region
| Japan |
Condition
Condition
Allergy to COVID19 vaccine
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the causative agents and background factors of COVID19 vaccine allergy.
Basic objectives2
Others
Basic objectives -Others
Searching for the cause of a disease state
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prick test positivity rate in patients allergic to COVID-19 vaccine
Key secondary outcomes
Positive rates of blood counts, serum total IgE levels, and basophil stimulation tests in patients allergic to COVID-19 vaccine and healthy volunteers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Prick test with vaccine additives
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who are 16 years of age or older at the time of obtaining consent.
(2) Those who, after receiving sufficient explanation and understanding, have given their free written consent to participate in this study.
Key exclusion criteria
(1) Those who have refused to participate in this research.
(2) Others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Koremasa |
| Middle name | |
| Last name | Hayama |
Organization
Nihon University School of Medicine
Division name
Division of Cutaneous Science, Department of Dermatology
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
hayama.koremasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Koremasa |
| Middle name | |
| Last name | Hayama |
Organization
Nihon University School of Medicine
Division name
Division of Cutaneous Science, Department of Dermatology
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
hayama.koremasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee.
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
Tel
03-3972-8111
komoda.nozomi@nihon-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 | 09 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
Suspended
Date of protocol fixation
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2025 | 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 | 09 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052009
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
