UMIN-CTR Clinical Trial

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
Email	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
Email	tokura@chutoen-hp.shizuoka.jp

Sponsor
Institute	Allergic Disease Research Center, Chutoen General Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050818