臨床研究等提出・公開システム

Japanese

Date of registration	April. 30, 2025
Last modified on	May. 20, 2025
Trial ID	jRCT1030250071

Scientific Title	Comparative study of blood S-reactive IgG4 antibody levels, N-reactive IgG total antibody levels, and S-reactive IgG total antibody levels in IgG antibody tests of Covid19 mRNA vaccine recipients and non-vaccinated individuals
Public Title	COVID-19; Comparative Study of Serum S-reactive IgG4 Antibody Levels, N-reactive IgG Antibody Levels, and S-reactive IgG Antibody Levels in COVID-19 mRNA Vaccine Recipients and Non-Recipients using IgG Antibody Testing

Contact for Scientific Queries	Name	Bando Tomoaki
	Affiliation	KANDANISHIGUCHI CLINIC
	Address	101-0047 Tokyo, Chiyoda-ku, Uchikanda 3-12-4 Daiichigishi Building 3rd floor
	Telephone	+81-3-3525-7377
	E-mail	cro@jscsf.net
Contact for Public Queries	Name	Kobayashi Hidy
	Affiliation	Japan Society of Clinical Study for Frontier-Medicine
	Address	1-8-16-6F Yaesu, Chuo-ku, Tokyo
	Telephone	+81-3-5542-1597
	E-mail	cro@jscsf.net

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 30, 2025
Actual date of first enrollment
Target sample size		180
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese people (non-naturalized Japanese nationals) who meet the following requirements. We are looking for 20 people each who have not received the mRNA vaccine and who have received 1 to 8 doses of the mRNA vaccine. 1) Those who have not received the mRNA vaccine: 20 people 2) Those who have received 1 dose of the mRNA vaccine: 20 people 3) Those who have received 2 doses of the mRNA vaccine: 20 people 4) Those who have received 3 doses of the mRNA vaccine: 20 people 5) Those who have received 4 doses of the mRNA vaccine: 20 people 6) Those who have received 5 doses of the mRNA vaccine: 20 people 7) Those who have received 6 doses of the mRNA vaccine: 20 people 8) Those who have received 7 doses of the mRNA vaccine: 20 people 9) Those who have received 8 doses of the mRNA vaccine: 20 people
	Exclusion Criteria	1) Non-Japanese. 2) Patients currently participating in other clinical trials, or patients who have participated in a clinical trial in the past and for whom more than one month has not passed since the last dose of the test drug. 3) Patients who are unable to register for this study via online medical consultation or online electronic device, or who are unable to enter data or send it via the Internet, either by themselves or their legal representative. 4) Patients who the principal investigator or co-investigator of the study deems inappropriate as subjects.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		none
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		IgG antibody test: amount of S-reactive IgG4 antibody, N-reactive IgG antibody, and S-reactive IgG antibody in blood
Secondary Outcome(s)		Measure the incidence of adverse events using CTCAE

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	JSCSF-CRB
Address	1-8-16-6F Yaesu, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-5542-1597
E-Mail	mail@jscsf.net
Approval Status	Approval
Date of approval	Oct. 23, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 20, 2025	(this page)	Changes
1	April. 30, 2025	Detail

List of change history