UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Acronym	Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Scientific Title	Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Scientific Title:Acronym	Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Region	Japan

Condition
Condition	Healthy Subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine immune response and the relation with background in subjects inoculated with SARS-CoV-2 vaccine.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SARS-CoV-2 neutralizing antibody titer Anti-spike protein IgG antibody titer Cellular immunity (cytokine-producing cell count)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Blood sampling
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Participants who will vaccinate against SARS-CoV-2 2. Participants who signed informed consent. 3. Participants who agreed to participate in "Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination" (UMIN ID:UMIN000045107) conducted by Shionogi & Co., Ltd.
Key exclusion criteria	1. Participants who have been confirmed to have a history of SARS-CoV-2 infection. 2. A loss of > 200 mL of whole blood or blood components within 12 weeks or > 100 mL within 4 weeks of the first dose of study intervention in male participants. A loss of > 200 mL of whole blood or blood components within 16 weeks or > 100 mL within 4 weeks of the first dose of study intervention in female participants. 3. Current enrollment or past participation within the last 30 days before signing of ICF in any other clinical study involving an clinical study or any other type of medical research. 4. Participants who have been confirmed to be positive in human immunodeficiency virus (HIV) antigen/antibody test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody test result.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Toshinobu Middle name Last name Iwasaki
Organization	Shionogi & Co., Ltd.
Division name	Drug Development and Regulatory Science Division
Zip code	541-0045
Address	1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan
TEL	06-6202-2161
Email	Shokuiki_antibody@shionogi.co.jp

Public contact
Name of contact person	1st name Yohei Middle name Last name Seki
Organization	Shionogi & Co., Ltd.
Division name	Clinical Research Department
Zip code	541-0045
Address	1-8, Doshomachi 3-Chome, Chuo-ku, Osaka, Japan
TEL	06-6202-2161
Homepage URL
Email	Shokuiki_antibody@shionogi.co.jp

Sponsor
Institute	Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization	Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Non-Profit Organization MINS Institutional Review Board
Address	20-9-401, 5-chome, Mita, Minato-ku, Tokyo, Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.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 16 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	143
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	No longer recruiting
Date of protocol fixation	2021 Year 08 Month 19 Day
Date of IRB	2021 Year 08 Month 19 Day
Anticipated trial start date	2021 Year 09 Month 02 Day
Last follow-up date	2022 Year 09 Month 30 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 15 Day
Last modified on	2021 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051936