Efficacy and Safety of the BNT162b2, mRNA-1273, and ChAdOx1-S COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
- Conditions
- B cell non-Hodgkin lymphoma, Post-transplant Lymphoproliferative Disorders, Idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
- Registration Number
- JPRN-UMIN000046043
- Lead Sponsor
- Kobe City Medical Center General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 152
Not provided
1) Patients whom the principal investigator or sub-investigator judges to be inappropriate for participation in the study 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 a history of or coexistence 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 syndrome, inflammatory bowel disease, Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica) 5) Patients who are unable to communicate with others
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the rate of SARS-CoV-2 IgG antibody positivity.
- Secondary Outcome Measures
Name Time Method Secondary endpoints will be SARS-CoV-2 IgG antibody titer, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post-vaccination adverse reactions.