NCT04852796

Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Centre Hospitalier de Cornouaille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU). Hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). The severity of Covid-19 may be related to their treatment, in particular anti-CD20 used in B lymphoid hemopathies. In fact, anti-CD20 antibodies induce rapid and prolonged depletion of B cells, but they are necessary for development. humoral immune responses. But currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.

Detailed description

The aim of this study is to evaluate the humoral response after vaccination against SARS-CoV-2 in a French multicenter cohort of patients with hemopathies. Analysis of hemopathies and immunochemotherapy subgroups will determine whether there is a need to strengthen immunization schedules. In addition, the study wish to assess the safety and clinical efficacy of mRNA vaccines in this cohort.

Conditions

• Covid19
• Hematologic Malignancy
• Vaccine Response Impaired

Interventions

Type	Name	Description
OTHER	Patients with hemopathy	optimal humoral response at 1 month after COVID-19 vaccination

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-04-01
• Completion: 2023-04-01
• First posted: 2021-04-21
• Last updated: 2023-08-30

Locations

1 site across 1 country: France