UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047032 |
|---|---|
| Receipt number | R000053657 |
| Scientific Title | Humoral response after BNT162b2 vaccination in Japanese hemodialysis patients |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/04/14 18:56:15 |
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Basic information
Public title
Humoral response after BNT162b2 vaccination in hemodialysis patients
Acronym
Effectiveness of BNT162b2 vaccine in hemodialysis patients
Scientific Title
Humoral response after BNT162b2 vaccination in Japanese hemodialysis patients
Scientific Title:Acronym
Effectiveness of BNT162b2 vaccine in Japanese hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic renal failure during hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of BNT162b2 vaccine in Japanease hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody acquisition rate by BNT162b2 vaccine
Key secondary outcomes
Adverse events caused by BNT162b2 vaccine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
One hundred and eighty-five hemodialysis patients were vaccinated with 30 mg of BNT162b2 vaccine twice at 3-week intervals. Two weeks later, SARS-CoV-2 IgG antibodies were measured. Patients were also interviewed about adverse events of the vaccine.
Interventions/Control_2
Controls were 109 health care workers who received two doses of 30 mg of BNT162b2 vaccine at 3-week intervals. Two weeks later, SARS-CoV-2 IgG antibodies were measured. They were also interviewed about adverse events of the vaccine.
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
Patients undergoing hemodialysis three times a week at our hospital
Key exclusion criteria
Patients who have had COVID-19 in the past
Target sample size
294
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
9100004
Address
4-15-7, Houei, Fukui City
TEL
0776211277
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
9100004
Address
4-15-7, Houei, Fukui City
TEL
0776211277
Homepage URL
http://www.fujita-mhp.jp/
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui General Hospital
Address
58-16-1, Egami-cho, Fukui City
Tel
0776-59-1300
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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://rrtjournal.biomedcentral.com
Publication of results
Unpublished
Result
URL related to results and publications
https://rrtjournal.biomedcentral.com
Number of participants that the trial has enrolled
294
Results
Following vaccination, 97.6% of the hemodialysis group and 100% of the control group
were positive for the anti-spike antibody. The median level of anti-spike antibody was 2,728.7 AU/mL (IQR, 1,024.2-7,688.2 AU/mL) in the hemodialysis group and 10,500 AU/ml (IQR, 9,346.1-2,4500 AU/mL) in the health care workers group.
Results date posted
| 2022 | Year | 02 | Month | 28 | 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 185 hemodialysis patients was 68.7+-12.0 years with a male to female ratio of 125:60.The age of the health care workers was 50.6+-12.0 years with a male to female ratio of 22:87.
Participant flow
Adverse events
Adverse events to the vaccine were generally milder in hemodialysis patients than in health care workers.
Outcome measures
Antibody titer after vaccination in both groups and factors associated with low to no response to vaccine (age, sex, history of dialysis, presence of diabetes, serum albumin, lymphocyte count, BNP, PCR, nPCR, GNRI, Cr Index, BMI, iron dosage, oral steroids, oral immunosuppressants, complications of hematological diseases, and response to HBV vaccine).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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 | 17 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | 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=R000053657
