UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046999
Receipt number R000053619
Scientific Title Humoral response after BNT162b2 vaccine in Japanese hemodialysis patients
Date of disclosure of the study information 2022/12/01
Last modified on 2023/04/14 18:53:29

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Basic information

Public title

Humoral response after BNT162b2 vaccine in Japanese of hemodialysis patients

Acronym

Effectiveness of BNT162b2 vaccine in hemodialysis patients

Scientific Title

Humoral response after BNT162b2 vaccine in Japanese hemodialysis patients

Scientific Title:Acronym

Effectiveness of BNT162b2 vaccine in Japanese hemodialysis patients

Region

Japan


Condition

Condition

Hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effectiveness of BNT162b2 vaccine in hemodialysis patients

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acquisition rate of SARS-CoV-2 IgG antibody after BNT162b2 vaccination

Key secondary outcomes

Adverse events of BNT162b2 vaccine


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

Patients undergoing hemodialysis at our hospital

Key exclusion criteria

Patients with no history of COVID-19

Target sample size

185


Research contact person

Name of lead principal investigator

1st name RYOICHI
Middle name
Last name MIYAZAKI

Organization

Fujita Memorial Hospital

Division name

Internal Medicine

Zip code

910-0004

Address

4-15-7, Hounaga, Fukui City, Fukui Prefecture

TEL

0776-21-1277

Email

ryoichi@mitene.or.jp


Public contact

Name of contact person

1st name RYOICHI
Middle name
Last name MIYAZAKI

Organization

Fujita Memorial Hospital

Division name

Internal Medicine

Zip code

910-0004

Address

4-15-7, Hounaga, Fukui City, Fukui Prefecture

TEL

0776-21-1277

Homepage URL

http://www.fujita-mhp.jp/

Email

ryoichi@mitene.or.jp


Sponsor or person

Institute

Fujita Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

Fujita Memorial Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukui General Hospital

Address

58-16-11, Egami-cho, Fukui City, Fukui Prefecture

Tel

0776-59-1300

Email

chiey@mx3.fctv.ne.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

藤田記念病院(福井県)


Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications

https://rrtjournal.biomedcentral.com/

Number of participants that the trial has enrolled

185

Results

The anti-SARS-CoV-2 IgG antibody positivity rate after BNT162b2 vaccine administration was 181/185 = 97.8% in the hemodialysis patients.The median antibody titer in hemodialysis patients was 2728.7 AU/mL, with a quartile range of 1024.2-7688.2 AU/mL.Adverse events associated with vaccine administration were mild.

Results date posted

2022 Year 02 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 12 Month 01 Day

Baseline Characteristics

The age of the patients was 68.7+-12.0 years, 125 were males and 87 were females. The dialysis vintage was 106+-60 months. Diabetes mellitus was the primary disease in 72 patients.

Participant flow

Patient inclusion was completed on October 22, 2022.

Adverse events

The most common adverse event was pain at the vaccination site (65.4%), but others were mild.

Outcome measures

The anti-SARS-CoV-2 IgG antibody positivity rate after BNT162b2 vaccine administration was 181/185 = 97.8%

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2021 Year 04 Month 14 Day

Date of IRB

2021 Year 05 Month 12 Day

Anticipated trial start date

2021 Year 05 Month 13 Day

Last follow-up date

2022 Year 02 Month 28 Day

Date of closure to data entry

2022 Year 02 Month 28 Day

Date trial data considered complete

2022 Year 02 Month 28 Day

Date analysis concluded

2022 Year 02 Month 28 Day


Other

Other related information

Two doses of BNT162b2 vaccine were administered to hemodialysis patients at a 3-week sensory interval, followed by a survey of SARS-CoV-2 IgG antibody titers approximately 2 weeks later.


Management information

Registered date

2022 Year 02 Month 24 Day

Last modified on

2023 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053619


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name