UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048638
Receipt number R000055076
Scientific Title Humoral and T-cell responses to a fourth dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Date of disclosure of the study information 2022/08/09
Last modified on 2023/11/07 12:58:04

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Basic information

Public title

Humoral and T-cell responses to a fourth dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.

Acronym

COVID-19 anti-CD20mAb 4th vaccine study

Scientific Title

Humoral and T-cell responses to a fourth dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.

Scientific Title:Acronym

COVID-19 anti-CD20mAb 4th vaccine study

Region

Japan


Condition

Condition

Hematological diseases

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate whether the fourth dose of mRNA vaccine against SARS-CoV-2 will result in antibody positivity in patients with hematologic diseases who have received rituximab or obinutuzumab within one year of receiving the two mRNA vaccines against SARS-CoV-2 and who are likely to have failed to produce SARS-CoV-2 IgG antibody or have low levels of the same antibody after the third vaccination. We also aim to evaluate whether a T-cell immune response is acquired by the fourth dose in this patient population. Adverse reactions to the fourth dose will also be evaluated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint was the rate of positivity for SARS-CoV-2 IgG antibodies.

Key secondary outcomes

Secondary endpoints will be SARS-CoV-2 IgG antibody titer, SARS-CoV-2 specific T-SPOT response, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post vaccination adverse reactions.


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who participated in the "Observational Study of SARS-CoV-2 IgG Antibody Titers and Adverse Reactions after Third dose of mRNA Vaccine in Healthy Volunteers (UMIN000046603)" and met all the selection criteria and did not violate any of the exclusion criteria will be included in this study.

3.3.1 Selection Criteria
1) Willingness to receive the fourth dose of SARS-CoV-2 vaccination initiated by the Japanese government or local authorities
2) Patients who have given written consent to participate in the study.

Key exclusion criteria

1) Patients deemed inappropriate for study participation by the principal investigator or study investigators
2) Patients who have received rituximab for non-hematologic diseases (granulomatosis polyangiitis, microscopic polyangiitis, refractory nephrotic syndrome)
3) Patients with a history of COVID-19
4) Patients with autoimmune diseases other than chronic idiopathic thrombocytopenic purpura (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis and polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and related diseases, vasculitis syndrome, inflammatory bowel disease, and Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica).
5) Patients who are unable to communicate.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Ishikawa

Organization

Kobe City Medical Center General Hospital

Division name

Department of Hematology

Zip code

6500047

Address

2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan

TEL

0783024321

Email

mnishi90@yahoo.co.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Nishikubo

Organization

Kobe City Medical Center General Hospital

Division name

Department of Hematology

Zip code

650-0047

Address

2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan

TEL

0783024321

Homepage URL


Email

mnishi90@yahoo.co.jp


Sponsor or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Kobe City Medical Center General Hospital

Address

2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan

Tel

0783024321

Email

rinken@kcho.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

2022 Year 08 Month 09 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

20

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

Completed

Date of protocol fixation

2022 Year 07 Month 08 Day

Date of IRB

2022 Year 07 Month 20 Day

Anticipated trial start date

2022 Year 07 Month 20 Day

Last follow-up date

2023 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing particluar


Management information

Registered date

2022 Year 08 Month 09 Day

Last modified on

2023 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055076


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name