UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049684 |
|---|---|
| Receipt number | R000052091 |
| Scientific Title | Robust antibody response after the third mRNA coronavirus vaccination in Japanese hemodialysis patients |
| Date of disclosure of the study information | 2022/12/04 |
| Last modified on | 2023/08/01 09:25:26 |
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Basic information
Public title
Robust antibody response after the third mRNA coronavirus vaccination in Japanese hemodialysis patients
Acronym
Robust antibody response to the third mRNA vaccine in dialysis patients
Scientific Title
Robust antibody response after the third mRNA coronavirus vaccination in Japanese hemodialysis patients
Scientific Title:Acronym
Robust antibody response to the third mRNA vaccine in dialysis patients
Region
| Japan |
Condition
Condition
COVID-19 in hemodialysis patients
Classification by specialty
| Nephrology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Response to the third coronavirus mRNA vaccination in hemodialysis patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive rate of SARS-CoV-2 IgG antibody 2-3 weeks after 3 doses of BNT162b2 mRNA vaccine
Key secondary outcomes
Analysis of factors involved in the elevation of SARS-CoV-2 IgG antibodies in mRNA vaccines
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who have cooperated in writing in this study
Key exclusion criteria
Patients with a history of COVID-19 prior to study entry or with a positive blood test for anti-SARS-CoV-2 IgG antibodies at the time of study entry
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryochi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7 Houei, Fukui City
TEL
0776-21-1277
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, Houei Fukui City
TEL
0776-21-1277
Homepage URL
http://www.fujita-mhp.jp/
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital, Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Memorial Hospital, Internal Medicine
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
Fujita Memorial Hospital
Address
4-15-7, Houei Fukui City
Tel
+811776211277
ryoichi@mitene.or.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 04 | 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
After the third vaccination, 99.4% of the hemodialysis group and 100% of the control group were positive for antispike antibodies. Median antispike antibodies were 20,000 AU/mL (IQR, 7,729-37,000 AU/mL) in the hemodialysis group and 21,500 AU/ml (IQR, 14,000-32,250 AU/mL) in the healthcare worker group.
Results date posted
| 2022 | Year | 12 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The hemodialysis group is patients on maintenance hemodialysis at our hospital and the health care providers are employees working at our hospital. Written informed consent for the study was obtained for both groups.
Participant flow
There were dropouts in each group between the second and third vaccinations. In the hemodialysis group, 9 deaths, 3 transfers, 2 BT infections, 1 refusal to vaccinate, and 3 delayed vaccinations dropped out. In the health care workers, 8 cases retired and 1 case had adverse dropout after the second vaccination.
Adverse events
No serious adverse events were observed in both groups.
Outcome measures
Analysis of anti-spike antibody titers and factors related to antibody titers in each group after the third immunization.
Plan to share IPD
No individual case data sharing plan.
IPD sharing Plan description
No individual case data sharing plan.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 03 | Day |
Other
Other related information
No other relevant information
Management information
Registered date
| 2022 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052091
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| Registered date | File name |
| Research case data | |
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