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

NCT ID: NCT04852796

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-04-01

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.

Conditions

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Covid19 Hematologic Malignancy Vaccine Response Impaired

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Patients with hemopathy

optimal humoral response at 1 month after COVID-19 vaccination

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Cornouaille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LENAIG LE CLECH, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Quimper Cornouaille

Locations

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Centre Hospitalier de Quimper Cornouaille

Quimper, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35667558 (View on PubMed)

Other Identifiers

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QP2021-PPD

Identifier Type: -

Identifier Source: org_study_id

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