UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058246 |
|---|---|
| Receipt number | R000066501 |
| Scientific Title | Investigation of Cellular, Humoral, and Memory Immune Responses to COVID-19 Vaccination in Dialysis Patients |
| Date of disclosure of the study information | 2025/06/22 |
| Last modified on | 2025/06/21 19:31:30 |
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Basic information
Public title
Investigation of Cellular, Humoral, and Memory Immune Responses to COVID-19 Vaccination in Dialysis Patients
Acronym
Investigation of Cellular, Humoral, and Memory Immune Responses to COVID-19 Vaccination in Dialysis Patients
Scientific Title
Investigation of Cellular, Humoral, and Memory Immune Responses to COVID-19 Vaccination in Dialysis Patients
Scientific Title:Acronym
Investigation of Cellular, Humoral, and Memory Immune Responses to COVID-19 Vaccination in Dialysis Patients
Region
| Japan |
Condition
Condition
COVID-19, hemodialysis
Classification by specialty
| Nephrology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate, in a multicenter study, the changes in antibody titers, cellular immunity, humoral immunity, and memory immunity at 6 months after primary COVID-19 vaccination and 1 month after the booster vaccination in dialysis patients, and to compare them with those in non-dialysis individuals
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 IgG antibody titers, cellular immunity, humoral immunity, and memory cells will be compared between 6 months after the primary vaccination and 1 month after the booster 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Dialysis Patients]
Individuals receiving hemodialysis or peritoneal dialysis at participating institutions or affiliated facilities who have received two doses of a COVID-19 vaccine (either Pfizer or Moderna).
[Non-Dialysis Patients]
Staff members of Saiseikai Central Hospital in Tokyo or its affiliated facilities (Konan no Sato), their family members or acquaintances, or outpatients regularly seen at Saiseikai Central Hospital, who have received two doses of a COVID-19 vaccine (either Pfizer or Moderna).
Key exclusion criteria
Individuals with a history of malignancy treatment within the past year or those receiving steroids or immunosuppressive agents will be excluded. In the non-dialysis group, individuals with an eGFR of 45 mL/min/1.73 m2 or lower, or those diagnosed with nephrotic syndrome, will also be excluded.
Target sample size
336
Research contact person
Name of lead principal investigator
| 1st name | Munekazu |
| Middle name | |
| Last name | Ryuzaki |
Organization
Tokyo Saiseikai Central Hospital
Division name
Nephrology
Zip code
108-0073
Address
1-4-17 Mita Mimato-ku,Tokyo
TEL
+81-3-3451-8211
jsdt.vaccine.antibody@gmail.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshifuji |
Organization
Tokyo Saiseikai Central Hospital
Division name
Nephrology
Zip code
108-0073
Address
1-4-17 Mita Mimato-ku,Tokyo
TEL
+81-3-3451-8211
Homepage URL
jsdt.vaccine.antibody@gmail.com
Sponsor or person
Institute
Tokyo Saiseikai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee,Tokyo Saiseikai Central Hospital
Address
1-4-17 Mita Mimato-ku,Tokyo
Tel
+81-3-3451-8211
kenkyu@saichu.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
| 2025 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.tobu.saiseikai.or.jp/docs/pdf/optout/20210181_Opt.pdf
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38457030/
Number of participants that the trial has enrolled
336
Results
Booster vaccination enhanced immune responses in all groups. HD patients showed significantly higher levels of IgG antibodies, IL-1b, IL-2, IL-4, IL-17, and memory B cells than controls. PD patients showed similar trends, but their levels were comparable to the control group.
Results date posted
| 2025 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 08 | Day |
Baseline Characteristics
Participants in the control, hemodialysis (HD), and peritoneal dialysis (PD) groups were recruited from 12 medical facilities.
All participants had completed primary COVID-19 vaccination (BNT162b2) and were evaluated at 6 months after the second dose and 3 weeks after the booster (third dose).
Participant flow
Control, HD, and PD groups were prospectively enrolled from multiple centers.
Blood samples were collected at two time points: 6 months after primary vaccination and 3 weeks after the booster vaccination, followed by immunological assessments.
Adverse events
No serious adverse events
Outcome measures
SARS-CoV-2 IgG antibody titers
Antigen-specific cytokines
Memory B cell counts
Regulatory T cell counts
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will provide blood samples for the evaluation of SARS-CoV-2 antibody levels. Patient background information will be collected, including dialysis duration, conditions an d laboratory data for dialysis patients.
Management information
Registered date
| 2025 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066501
