UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044500 |
|---|---|
| Receipt number | R000050362 |
| Scientific Title | Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2024/03/26 22:14:05 |
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Basic information
Public title
Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan
Acronym
Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan
Scientific Title
Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan
Scientific Title:Acronym
Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan
Region
| Japan |
Condition
Condition
dialysis patients
Classification by specialty
| Nephrology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study was to validate the efficacy of the vaccine by comparing antibody titers against SARS-CoV-2 after vaccination in dialysis patients with those in non-dialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody titer of anti-spike protein IgG before first vaccination, at the time of the second vaccination, and 14 days after the second vaccination, 90 days, and 180 days after 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient who have been attending the dialysis center of our hospitals during the above registration period
Key exclusion criteria
aged <16 years
being infected SARS-CoV-2 and in isolation
having already received the vaccine
not wishing to be vaccinated by their own choice or on the recommendation of their physician; and
did not provide informed consent.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory medicine
Zip code
251-0041
Address
Tsujidokandai1-5-1, Fujisawa
TEL
0466351177
chigasaki30@gamil.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory Medicine
Zip code
251-0041
Address
Tsujidokandai1-5-1, Fujisawa
TEL
0466351177
Homepage URL
chigasaki30@gamil.com
Sponsor or person
Institute
Shonan Fujisiawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Fujisawa Tokushukai 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
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
0332634801
mirai-ec1@mirai-iryo.com
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
湘南藤沢徳洲会病院、大隅鹿屋病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
NOTHING
Publication of results
Unpublished
Result
URL related to results and publications
nothing
Number of participants that the trial has enrolled
170
Results
Patients on dialysis were safely vaccinated with low reactogenicity; however, their immunogenicity to vaccination was lower and might be less effective in preventing COVID-19.
In patients on dialysis, real-world vaccination efficacy should be evaluated.
In addition to the vaccine, it is important for patients on dialysis, HCWs, and their close family members to take standard preventive measures against infection.
Results date posted
| 2024 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 170 outpatients undergoing dialysis in our dialysis center, those aged 16 years and older who desired to be vaccinated with BNT162b2 were enrolled. Patients with a history of SARS-CoV-2 infection were included provided that they had completed the isolation period and had recovered. As controls, we included patients aged 16 years and older who were attending the outpatient departments of respiratory medicine and rheumatology in Shonan Fujisawa Tokushukai Hospital, wanting to be vaccinated with BNT162b2, and not receiving anticancer drugs or immunosuppressive therapy in ongoing observational studies on the immunogenicity of SARS-CoV-2 vaccines.
Participant flow
Participants
We enrolled 145 chronic dialysis patients and 132 non-dialysis controls, all of whom were Japanese. Among the dialysis patients, two hemodialysis patients could not be fully vaccinated during the study period because of unscheduled hospitalization after the first vaccine dose: one owing to superior mesenteric artery embolism and the other because of the coincidence of cerebral hemorrhage and COVID-19. Therefore, we conducted the final analysis on 143 dialysis patients and 132 control patients who were fully vaccinated. Among the dialysis patients, 141 were on hemodialysis (99%), one on peritoneal dialysis (0.7%), and another on hybrid dialysis (0.7%), a combination of the two.
Adverse events
143 dialysis participants completed questionnaires. The most common adverse reactions after both vaccinations were pain and malaise. Data from a Japanese Ministry of Health study showed fewer men and younger participants compared to our dialysis group. Within a week after vaccination, local reactions included pain (92-90), burning sensation (13-19), itching (8-12), redness (14-16), swelling (13-14), and induration (21-10). Systemic reactions included headache (21-53), malaise (23-69), runny nose (10-14), and fever >37.5 (3-38). No adverse reaction was significantly more frequent in the dialysis group, but they experienced more redness, burning sensation, induration, pain, malaise, fever, and headache compared to controls.
Outcome measures
Results: Spike (S)-IgG antibody levels in dialysis patients increased from the first vaccination to 14 days after the second vaccination (P<0.001). However, S-IgG antibody levels were lower in dialysis patients than in controls at 14 days after full vaccination (median [IQR]: 4528.3 [1774.5-8514.8] AU/ml vs. 12422.1 [6778.7-21964.5] AU/ml; P<0.001). Compared to historical data, adverse reaction (AR) incidence was lower in the dialysis group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This double-center prospective observational study was conducted at Shonan Fujisawa Tokushukai Hospital in Kanagawa and Osumikanoya Hospital in Kagoshima, Japan. Patients were enrolled from June to July 2021 and followed up for 180 days after the first vaccination. As control group, we included outpatients at our hospital who were not receiving anticancer drugs or immunosuppressive therapy.
Management information
Registered date
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050362
