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

Sponsor
Centre Hospitalier de Cornouaille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04852796
Collaborator
(none)
1,000
Enrollment
1
Location
24
Anticipated Duration (Months)
41.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Outcome Measures

Primary Outcome Measures

  1. humoral response after COVID19 vaccination [1 month after vaccination]

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

Secondary Outcome Measures

  1. humoral response after COVID19 vaccination [before first dose vaccination]

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

  2. humoral response after COVID19 vaccination [before second dose vaccination]

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

  3. humoral response after COVID19 vaccination [3 months after vaccination]

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

  4. humoral response after COVID19 vaccination [6 months after vaccination]

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

  5. humoral response after COVID19 vaccination [12 months after vaccination]

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

  6. clinical response after COVID19 vaccination [12 months after vaccination]

    SARS-CoV-2 disease onset in the follow-up

  7. security of mRNA COVID19 vaccine [3 months after vaccination]

    side effects onset in the follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de Quimper Cornouaille Quimper France 29000

Sponsors and Collaborators

  • Centre Hospitalier de Cornouaille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier de Cornouaille
ClinicalTrials.gov Identifier:
NCT04852796
Other Study ID Numbers:
  • QP2021-PPD
First Posted:
Apr 21, 2021
Last Update Posted:
Apr 21, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Hematologic Neoplasms

Study Results

No Results Posted as of Apr 21, 2021