Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Centre Hospitalier de Cornouaille
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- humoral response after COVID19 vaccination
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Benign or malignant hemopathy
- •With priority vaccination indication
- •Having benefited from anti-covid-19 mRNA vaccination
Exclusion Criteria
- •Patients under legal protection
- •Palliative care patients
- •History of known Covid-19 disease (\<1 year)
Outcomes
Primary Outcomes
humoral response after COVID19 vaccination
Time Frame: 1 month after vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
Secondary Outcomes
- clinical response after COVID19 vaccination(12 months after vaccination)
- security of mRNA COVID19 vaccine(3 months after vaccination)
- humoral response after COVID19 vaccination(12 months after vaccination)