Clinical trial NCT04852796: Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
Official title: Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Hematologic Malignancy
Vaccine Response Impaired
Lead sponsor: Centre Hospitalier de Cornouaille
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hemopathy followed in declared hospitals

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.

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)

Primary outcomes:
measure: humoral response after COVID19 vaccination
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: humoral response after COVID19 vaccination
timeFrame: before first dose vaccination
measure: humoral response after COVID19 vaccination
timeFrame: before second dose vaccination
measure: humoral response after COVID19 vaccination
timeFrame: 3 months after vaccination
measure: humoral response after COVID19 vaccination
timeFrame: 6 months after vaccination
measure: humoral response after COVID19 vaccination
timeFrame: 12 months after vaccination
measure: clinical response after COVID19 vaccination
timeFrame: 12 months after vaccination
measure: security of mRNA COVID19 vaccine
timeFrame: 3 months after vaccination
Other outcomes:
Locations:
city: Quimper
country: France
facility: Centre Hospitalier de Quimper Cornouaille
Study officials:
affiliation: Centre Hospitalier de Quimper Cornouaille
name: LENAIG LE CLECH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.