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CompletedNCT04852796HEMVACOUpdated Aug 30, 2023

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

An observational study in Covid19, Hematologic Malignancy and Vaccine Response Impaired, sponsored by Centre Hospitalier de Cornouaille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Centre Hospitalier de Cornouaille · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Covid19
  • Hematologic Malignancy
  • Vaccine Response Impaired
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Centre Hospitalier de Cornouaille is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with hemopathy followed in declared hospitals

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • OtherPatients with hemopathy

    optimal humoral response at 1 month after COVID-19 vaccination

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What researchers measure

Primary outcomes

  1. humoral response after COVID19 vaccination

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

    Time frame: 1 month after vaccination

Secondary outcomes

  1. humoral response after COVID19 vaccination

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

    Time frame: before first dose vaccination

  2. humoral response after COVID19 vaccination

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

    Time frame: before second dose vaccination

  3. humoral response after COVID19 vaccination

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

    Time frame: 3 months after vaccination

  4. humoral response after COVID19 vaccination

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

    Time frame: 6 months after vaccination

  5. humoral response after COVID19 vaccination

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

    Time frame: 12 months after vaccination

  6. clinical response after COVID19 vaccination

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

    Time frame: 12 months after vaccination

  7. security of mRNA COVID19 vaccine

    side effects onset in the follow-up

    Time frame: 3 months after vaccination

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Study locations

1 site
  • Centre Hospitalier de Quimper Cornouaille
    Quimper, 29000, France
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References and documents

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. PubMed 35667558 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04852796
Lead sponsor
Centre Hospitalier de Cornouaille
Responsible party
Sponsor
First posted
Apr 21, 2021
Start date
Apr 1, 2021
Primary completion
Apr 1, 2022
Completion
Apr 1, 2023
Last update
Aug 30, 2023

Study contacts

LENAIG LE CLECH, PhD
principal investigator · Centre Hospitalier de Quimper Cornouaille

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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