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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048638

Enrollment

Registered

2022-08-09

Start date

2022-07-20

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: 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.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactMasashi Nishikubo

Kobe City Medical Center General Hospital Department of Hematology

mnishi90@yahoo.co.jp0783024321

Outcome results