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

Completed

• Conditions: Covid19; Hematologic Malignancy; Vaccine Response Impaired

• Registration Number: NCT04852796
• Lead Sponsor: Centre Hospitalier de Cornouaille

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.

Study Timeline

• Study First Submitted: 2021-03-30
• Study Start: 2021-04-01
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Primary Completion: 2022-04-01
• Study Completion: 2023-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
humoral response after COVID19 vaccination	1 month after vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)

Secondary Outcome Measures

Name	Time	Method
clinical response after COVID19 vaccination	12 months after vaccination	SARS-CoV-2 disease onset in the follow-up
humoral response after COVID19 vaccination	12 months after vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
security of mRNA COVID19 vaccine	3 months after vaccination	side effects onset in the follow-up

Trial Locations

Locations (1)

Centre Hospitalier de Quimper Cornouaille; 🇫🇷 Quimper, France