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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Hematologic Malignancy, Vaccine Response Impaired

Intervention / Treatment
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* Other: Patients with hemopathy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patients with hemopathy|optimal humoral response at 1 month after COVID-19 vaccination|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | before first dose vaccination | 
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | before second dose vaccination | 
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | 3 months after vaccination | 
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | 6 months after vaccination | 
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | 12 months after vaccination | 
| clinical response after COVID19 vaccination | SARS-CoV-2 disease onset in the follow-up | 12 months after vaccination | 
| security of mRNA COVID19 vaccine | side effects onset in the follow-up | 3 months after vaccination |