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

Covid19 Clinical Trial

— HEMVACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852796
• Other study ID #: QP2021-PPD
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier de Cornouaille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hematologic Malignancy
• Hematologic Neoplasms
• Vaccine Response Impaired

Intervention

Other:
• Patients with hemopathy
optimal humoral response at 1 month after COVID-19 vaccination

Locations

Country	Name	City	State
France	Centre Hospitalier de Quimper Cornouaille	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Cornouaille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	1 month after vaccination
Secondary	humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	before first dose vaccination
Secondary	humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	before second dose vaccination
Secondary	humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	3 months after vaccination
Secondary	humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	6 months after vaccination
Secondary	humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	12 months after vaccination
Secondary	clinical response after COVID19 vaccination	SARS-CoV-2 disease onset in the follow-up	12 months after vaccination
Secondary	security of mRNA COVID19 vaccine	side effects onset in the follow-up	3 months after vaccination