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

NCT04852796 | Completed

• 1 other identifier: QP2021-PPD
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Response Impaired; Covid19; Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• humoral response after COVID19 vaccination

  SARS-CoV-2 Trimeric S IgG titers (BAU/ml)

  1 month after vaccination

Secondary Outcomes (7)

• humoral response after COVID19 vaccination

  before first dose vaccination

• humoral response after COVID19 vaccination

  before second dose vaccination

• humoral response after COVID19 vaccination

  3 months after vaccination

• humoral response after COVID19 vaccination

  6 months after vaccination

• humoral response after COVID19 vaccination

  12 months after vaccination

Interventions

Patients with hemopathy OTHER

optimal humoral response at 1 month after COVID-19 vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hemopathy followed in declared hospitals

You may qualify if:

• Benign or malignant hemopathy
• With priority vaccination indication
• Having benefited from anti-covid-19 mRNA vaccination

You may not qualify if:

• Patients under legal protection
• Palliative care patients
• History of known Covid-19 disease (\<1 year)

Sponsors & Collaborators

• Centre Hospitalier de Cornouaille: lead

Study Sites (1)

Centre Hospitalier de Quimper Cornouaille

Quimper, 29000, France

Location

Related Publications (1)

• 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.

  PMID: 35667558 DERIVED

MeSH Terms

Conditions

COVID-19; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• LENAIG LE CLECH, PhD

  Centre Hospitalier de Quimper Cornouaille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 21, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

FR (1)