UMIN-CTR Clinical Trial

Basic information
Public title	Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Acronym	Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Scientific Title	Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Scientific Title:Acronym	Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Basic objectives2	Others
Basic objectives -Others	To confirm antibodies against SARS-CoV-2 variants in adults after vaccination
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Persons over 20 years old who have received two doses of Pfizer's SARS-CoV-2 vaccine and have been vaccinated for at least two weeks, and who can consent to donating a sample (30 persons) 2.Persons who participated in a clinical study prior to the COVID-19 pandemic outbreak (prior to December 2019) and who consented to their samples being used for measurements other than those in the study at that time (10 persons)
Key exclusion criteria	None
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Ohkuma
Organization	Research Center for Immunological Analysis, Inc.
Division name	None
Zip code	701-1221
Address	5303 Haga, Kita-ku, Okayama-shi, Okayama
TEL	086-286-9333
Email	a-okuma@menekibunseki.com

Public contact
Name of contact person	1st name Kana Middle name Last name Nagase
Organization	Research Center for Immunological Analysis, Inc.
Division name	None
Zip code	701-1221
Address	5303 Haga, Kita-ku, Okayama-shi, Okayama
TEL	086-286-9333
Homepage URL
Email	k-nagase@menekibunseki.com

Sponsor
Institute	Research Center for Immunological Analysis, Inc.
Institute
Department

Funding Source
Organization	None
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	Yamada Bee Company Ethics Committee
Address	194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel	0868-54-1199
Email	rt2067@yamada-bee.com

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 10 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	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 08 Month 30 Day
Anticipated trial start date	2021 Year 09 Month 10 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 09 Month 07 Day
Last modified on	2021 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051846