UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045492
Receipt number R000051936
Scientific Title Prospective study on evaluation of immune response after SARS-CoV-2 vaccination
Date of disclosure of the study information 2021/09/16
Last modified on 2021/09/15 20:01:34

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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 or person

Institute

Shionogi & Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051936


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name