Unique ID issued by UMIN | UMIN000046603 |
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Receipt number | R000053163 |
Scientific Title | Humoral and T-cell responses to a third 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 | 2022/01/11 |
Last modified on | 2023/01/12 15:06:04 |
Humoral and T-cell responses to a third dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Rituximab or obinutuzumab a third dose study
Humoral and T-cell responses to a third dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Rituximab or obinutuzumab a third dose study
Japan |
Hematological diseases
Hematology and clinical oncology |
Malignancy
NO
The purpose of this study is to evaluate the efficacy and safety of a third dose of mRNA vaccine against SARS-CoV-2 in patients with hematologic diseases who have previously received rituximab or obinutuzumab.
Safety,Efficacy
The primary endpoint was the rate of positive SARS-CoV-2 IgG antibodies before and after the third vaccination.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
1) Adult patients who have received rituximab/obinutuzumab for hematological diseases (B-cell non-Hodgkin's lymphoma, B-cell lymphoproliferative disease under immunosuppressive conditions, chronic idiopathic thrombocytopenic purpura, acquired thrombocytopenic purpura)
2) Patients who have received the first and second doses of SARS-CoV-2 vaccination sponsored by the Japanese government or local government, the date and time of the vaccination can be confirmed, and the first dose of SARS-CoV-2 vaccine was administered within 12 months of the last dose of rituximab or obinutuzumab. The date and time of vaccination can be confirmed, and the first dose of SARS-CoV-2 vaccine is within 12 months of the last dose of rituximab/obinutuzumab.
3) Be willing to receive the third dose of SARS-CoV-2 vaccination initiated by the Japanese government or local government.
4) Written consent has been obtained from the subject for participation in the study.
1) Patients who are judged inappropriate for participation in the study by the investigators
2) Patients who have previously received rituximab for non-hematological diseases (polyangiitis granulomatosa, 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/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and related diseases, vasculitis syndromes, inflammatory bowel disease, Guillain-Barre syndrome, and inflammatory bowel disease) Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica).
5) Patients who are unable to communicate with others
100
1st name | Takayuki |
Middle name | |
Last name | Ishikawa |
Kobe City Medical Center General Hospital
Department of Hematology
650-0047
2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
0783024321
ishikawa@kcho.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
masashi_nishikubo@kcho.jp
Kobe City Medical Center General Hospital, Department of Hematology
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 | 01 | Month | 11 | Day |
Unpublished
68
Completed
2022 | Year | 01 | Month | 10 | Day |
2022 | Year | 01 | Month | 20 | Day |
2022 | Year | 01 | Month | 20 | Day |
2023 | Year | 07 | Month | 31 | Day |
Nothing particular
2022 | Year | 01 | Month | 11 | Day |
2023 | Year | 01 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053163
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