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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with hemopathy | Other | optimal humoral response at 1 month after COVID-19 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| humoral response after COVID19 vaccination | SARS-CoV-2 Trimeric S IgG titers (BAU/ml) | 1 month after vaccination |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hemopathy followed in declared hospitals
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| Name | Affiliation | Role |
|---|---|---|
| LENAIG LE CLECH, PhD | Centre Hospitalier de Quimper Cornouaille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Quimper Cornouaille | Quimper | 29000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35667558 | Derived | Gueguen M, Khatchatourian L, Loheac C, Dorval I, Mercier M, Le Calloch R, Mahe K, Rizcallah MJ, Hutin P, Fangous MS, Saidani N, Le Clech L. The humoral response of mRNA COVID-19 vaccine in hematological diseases: The HEMVACO study. Infect Dis Now. 2022 Aug;52(5):280-285. doi: 10.1016/j.idnow.2022.05.008. Epub 2022 Jun 3. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |