UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044489 |
|---|---|
| Receipt number | R000050818 |
| Scientific Title | Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2021/12/13 16:22:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Acronym
Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Scientific Title
Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Scientific Title:Acronym
Investigation on possible down-regulation of adverse effects of SARS-CoV-2 vaccination by type 2 allergic diseases using questionnaire to vaccine recipients
Region
| Japan |
Condition
Condition
vaccine adverse effects
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will conduct a questionnaire survey to approximately 1,000 workers in our hospital. We will investigate the adverse effects following the first and second administration of Pfizer-BioNTech vaccine. The presence (and degrees) or absence of the injection site reactions, fever, tiredness, headache, and muscle pain will be questioned with the present and past histories of allergic diseases.
Basic objectives2
Others
Basic objectives -Others
In this study, we will conduct a questionnaire survey to approximately 1,000 workers in our hospital. We will investigate the adverse effects following the first and second administration of Pfizer-BioNTech vaccine. The presence (and degrees) or absence of the injection site reactions, fever, tiredness, headache, and muscle pain will be questioned with the present and past histories of allergic diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of differences in vaccine adverse effects (injection reactions [pain, swelling, and erythema], fever, headache, fatigability, muscle pain, joint pain, and others) between recipients who have present and past allergic diseases (atopic dermatitis, allergic rhinitis, bronchial asthma, and others) and those without these allergic diseases.
Key secondary outcomes
Evaluation of differences in the severity of vaccine adverse effects between recipients who have present and past allergic diseases (atopic dermatitis, allergic rhinitis, and bronchial asthma) and those without these allergic diseases.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Workers in Chutoen General Medical Hospital who received Cominaty vaccine and approve this project.
Key exclusion criteria
Apparent loss or mistake in the questionnaire sheet.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Tokura |
Organization
Allergic Disease Research Center,
Chutoen General Medical Center
Division name
Allergic Disease Research Center
Zip code
436-8555
Address
1-1 Shoubu-ga-ike, Kakegawa, Japan
TEL
0537-21-5555
tokura@chutoen-hp.shizuoka.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Tokura |
Organization
Allergic Disease Research Center, Chutoen General Medical Center
Division name
Allergic Disease Research Center
Zip code
436-8555
Address
1-1 Shoubu-ga-ike, Kakegawa, Japan
TEL
0537-21-5555
Homepage URL
tokura@chutoen-hp.shizuoka.jp
Sponsor or person
Institute
Allergic Disease Research Center, Chutoen General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Allergic Disease Research Center, Chutoen General Medical Center
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
Clinical Research Committee, Chutoen General Medical Center
Address
1-1 Shoubu-ga-ike, Kakegawa, Japan
Tel
0537-21-5555
rinshokenkyu@chutoen-hp.shizuoka.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 | 06 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-393X/9/12/1421
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-393X/9/12/1421
Number of participants that the trial has enrolled
955
Results
For the systemic reactions, fatigability after the first dose tended to be more severe in the bronchial asthma than in the non-allergic group. Headache, joint pain, and fever tended to be more severe in the food allergy than in the non-allergic group after the second dose. For the local skin reactions, atopic dermatitis subjects tended to show rather less severe local skin reactions after the second dose.
Results date posted
| 2021 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 01 | Day |
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 | 06 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 22 | Day |
Other
Other related information
Responders are approximately 1,100
workers in our hospital, including physicians, nurses, and other health care workers.
They were vaccinated with Cominaty (Pfizer BioNTech) in two doses about 21 day apart in our hospital. We will investigate the adverse effects following the first and second administration of Pfizer-BioNTech vaccine. The presence (and degrees) or absence of the injection site reactions, fever, tiredness, headache, and muscle pain is questioned with the present and past histories of allergic diseases. The questionnaire
survey is performed anonymously by marking the sheet. We evaluate differences in vaccine adverse effects (injection reactions [pain, swelling, and erythema], fever, headache, fatigability, muscle pain, joint pain, and others) between recipients who have present and past-histories of allergic diseases (atopic dermatitis, allergic rhinitis, bronchial asthma, and others) and those without these allergic diseases.
Management information
Registered date
| 2021 | Year | 06 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050818
