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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name