UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048810
Receipt number R000055572
Scientific Title Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster
Date of disclosure of the study information 2022/09/10
Last modified on 2023/03/02 09:48:35

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Basic information

Public title

Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster

Acronym

Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster

Scientific Title

Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster

Scientific Title:Acronym

Changes in specific antibody titers and interferon gamma levels after a BNT162b2 vaccine booster

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the change in immune responses by measuring spike-specific antibody titers and interferon gamma levels approximately 8 months after a BNT162b2 vaccine booster and comparing them to those before and one month after vaccination.

Basic objectives2

Others

Basic objectives -Others

To evaluate the difference in spike-specific antibody and interferon gamma levels after a BNT162b2 vaccine booster due to previous SARS-CoV-2 infection and COVID-19 vaccine history.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in spike-specific antibody titers and interferon gamma levels 8 months after a BNT162b2 vaccine booster.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Employees of Fukuoka City Hospital who have been measured spike-specific antibody titers and interferon gamma levels.

Key exclusion criteria

None

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Tani

Organization

Kyushu University Graduate School of Medical Sciences

Division name

Medicine and Biosystemic Science

Zip code

812-8582

Address

Fukuoka Japan, 3-1-1, Maidashi, Higashi-ku Fukuoka-shi, Fukuoka

TEL

+81-92-642-5229

Email

tani.kyushu.univ@gmail.com


Public contact

Name of contact person

1st name Naoki
Middle name
Last name Tani

Organization

Kyushu University Graduate School of Medical Sciences

Division name

Medicine and Biosystemic Science

Zip code

812-8582

Address

Fukuoka Japan, 3-1-1, Maidashi, Higashi-ku Fukuoka-shi, Fukuoka

TEL

+81-92-642-5229

Homepage URL


Email

tani.kyushu.univ@gmail.com


Sponsor or person

Institute

Fukuoka City Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Fukuoka City Hospital

Address

13-1 Yoshizukahonmachi, Hakata-ward, Fukuoka-city, Fukuoka 812-0046 JAPAN

Tel

+81-92-801-1011

Email

rinshou@adm.fukuoka-u.ac.jp


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

2022 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

No longer recruiting

Date of protocol fixation

2022 Year 08 Month 25 Day

Date of IRB

2022 Year 08 Month 25 Day

Anticipated trial start date

2022 Year 09 Month 07 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The observation of the changes in antibody responses and T-cell responses to SARS-CoV-2 spike peptides after a BNT162b2 vaccine booster.


Management information

Registered date

2022 Year 08 Month 31 Day

Last modified on

2023 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name