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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046603

Enrollment

100

Registered

2022-01-11

Start date

2022-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint was the rate of positive SARS-CoV-2 IgG antibodies before and after the third vaccination.	—

Countries

Japan

Contacts

Public ContactMasashi Nishikubo

Kobe City Medical Center General Hospital Department of Hematology

masashi_nishikubo@kcho.jp0783024321

Outcome results