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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Hematologic Malignancy; Vaccine Response Impaired
• Intervention / Treatment: Other: Patients with hemopathy

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Quimper, France, 29000
    • Centre Hospitalier de Quimper Cornouaille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with hemopathy followed in declared hospitals

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
humoral response after COVID19 vaccination	SARS-CoV-2 Trimeric S IgG titers (BAU/ml)	1 month after vaccination

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cornouaille
• Investigators: Principal Investigator: LENAIG LE CLECH, PhD, Centre Hospitalier de Quimper Cornouaille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Hematologic Diseases; COVID-19; Hematologic Neoplasms
• Other Study ID Numbers: QP2021-PPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No