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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04852796
Acronym
HEMVACO
Enrollment
1000
Registered
2021-04-21
Start date
2021-04-01
Completion date
2023-04-01
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hematologic Malignancy, Vaccine Response Impaired

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.

Interventions

OTHERPatients with hemopathy

optimal humoral response at 1 month after COVID-19 vaccination

Sponsors

Centre Hospitalier de Cornouaille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
humoral response after COVID19 vaccination1 month after vaccinationSARS-CoV-2 Trimeric S IgG titers (BAU/ml)

Secondary

MeasureTime frameDescription
humoral response after COVID19 vaccinationbefore first dose vaccinationSARS-CoV-2 Trimeric S IgG titers (BAU/ml)
clinical response after COVID19 vaccination12 months after vaccinationSARS-CoV-2 disease onset in the follow-up
security of mRNA COVID19 vaccine3 months after vaccinationside effects onset in the follow-up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026