UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044499
Receipt No. 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 2021/06/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email chigasaki30@gamil.com

Sponsor
Institute Shonan Fujsiawa Tokushukai Hospital
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2021 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050338

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.