UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045405
Receipt number R000051846
Scientific Title Survey of IgG and neutralizing antibodies against SARS-CoV-2 variants in adults after vaccination
Date of disclosure of the study information 2021/09/10
Last modified on 2021/12/02 14:35:14

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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 or person

Institute

Research Center for Immunological Analysis, Inc.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051846


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name