Unique ID issued by UMIN | UMIN000048638 |
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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 |
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.
COVID-19 anti-CD20mAb 4th vaccine study
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.
COVID-19 anti-CD20mAb 4th vaccine study
Japan |
Hematological diseases
Hematology and clinical oncology |
Malignancy
NO
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.
Safety,Efficacy
The primary endpoint was the rate of positivity for SARS-CoV-2 IgG antibodies.
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.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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.
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.
50
1st name | Takayuki |
Middle name | |
Last name | Ishikawa |
Kobe City Medical Center General Hospital
Department of Hematology
6500047
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
0783024321
mnishi90@yahoo.co.jp
1st name | Masashi |
Middle name | |
Last name | Nishikubo |
Kobe City Medical Center General Hospital
Department of Hematology
650-0047
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
0783024321
mnishi90@yahoo.co.jp
Kobe City Medical Center General Hospital
Self funding
Self funding
Kobe City Medical Center General Hospital
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
0783024321
rinken@kcho.jp
NO
2022 | Year | 08 | Month | 09 | Day |
Unpublished
20
Completed
2022 | Year | 07 | Month | 08 | Day |
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 07 | Month | 20 | Day |
2023 | Year | 07 | Month | 31 | Day |
Nothing particluar
2022 | Year | 08 | Month | 09 | Day |
2023 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055076
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