UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044499 |
|---|---|
| Receipt number | R000050338 |
| Scientific Title | Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination among outpatients receiving immunosuppressive therapy: A monocentric observational study in Japan |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2024/03/26 21:56:34 |
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Basic information
Public title
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination among outpatients receiving immunosuppressive therapy: A monocentric observational study in Japan
Acronym
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination among outpatients receiving immunosuppressive therapy: A monocentric observational study in Japan
Scientific Title
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination among outpatients receiving immunosuppressive therapy: A monocentric observational study in Japan
Scientific Title:Acronym
Immunogenicity and safety of severe acute respiratory syndrome coronavirus 2 vaccination among outpatients receiving immunosuppressive therapy: A monocentric observational study in Japan
Region
| Japan |
Condition
Condition
patients who were receiving immunosuppressive therapy
Classification by specialty
| Pneumology | Clinical immunology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of the vaccine in patients receiving immunosuppressive therapy with antibody titers against SARS-CoV-2 before and after SARS-CoV-2 vaccination, and to test the short-term safety of the vaccine in patients receiving immunosuppressive therapy with increased doses of drugs used for immunosuppressive therapy, unexpected hospitalizations, and deaths after SARS-CoV-2 vaccination
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, 3 weeks, 5 weeks, 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
Patients who were receiving immunosuppressive therapy, systemic steroids, immunosuppressive drugs, immunomodulators, anti-rheumatic drugs, biologics, and JAK inhibitors, for interstitial pneumonia and autoimmune diseases while attending the outpatient clinic of the Department of Respiratory Medicine, Rheumatology, Hepatobiliary and Pancreatic Diseases, and Dermatology at our hospital during the above registration period.
Key exclusion criteria
age less than 15 years,
infected with SARS-CoV-2 and quarantined,
already vaccinated,
not willing to be vaccinated on their own or on the recommendation of their physician,
undergoing treatment for cancer, and not providing informed consent.
Target sample size
200
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
Tsujidokandai 1-5-1, 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 Fujsiawa 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
03-3263-4801
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
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
285
Results
Fourteen days after full vaccination, anti-spike S-IgG antibody levels were lower in immunosuppressed patients than in controls (median [IQR]: 3566.9 [416.4-9340.1] AU/ml vs. 12422.1 [6778.7-21964.5] AU/ml; p<0.001). Multivariate log-normal linear regression analysis indicated the effect of age, corticosteroids, methotrexate, and immunosuppressant drugs on S-IgG levels after complete vaccination. No negative events occurred after vaccination in either group.
Results date posted
| 2024 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this single-center, prospective cohort study, 153 immunosuppressed patients (median age, 72 [interquartile range {IQR}, 61-78] years) and 132 control outpatients (median age, 72 [IQR], 58-78 years) received two BNT162b2 doses.
Participant flow
The participants provided blood samples for measuring the levels of anti-spike protein immunoglobulin G (IgG) against severe acute respiratory syndrome coronavirus-2 before the first vaccination, at the second vaccination, and 14 days after the second vaccination.
Adverse events
No negative events occurred after vaccination in either group.
Outcome measures
Fourteen days after full vaccination, anti-spike (S)-IgG antibody levels were lower in immunosuppressed patients than in controls (median [IQR]: 3566.9 [416.4-9340.1] AU/ml vs. 12422.1 [6778.7-21964.5] AU/ml; p<0.001). Multivariate log-normal linear regression analysis indicated the effect of age, corticosteroids, methotrexate, and immunosuppressant drugs on S-IgG levels after complete vaccination.
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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-center observational study was conducted at Shonan Fujisawa Tokushukai Hospital in Kanagawa Prefecture, Japan. Patients were enrolled from May to the end of December 2021 and followed up for 180 days after the first vaccination. As control group, we included patients attending the same outpatient department as above 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=R000050338
