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OpenTrials
Completed

NCT Number: NCT04852796

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Infections Lung Diseases Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Response Impaired Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Quimper Cornouaille

Quimper, 29000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patients with hemopathy

Other

optimal humoral response at 1 month after COVID-19 vaccination

Primary outcomes

  1. humoral response after COVID19 vaccination

    Time frame: 1 month after vaccination

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

Secondary outcomes

  1. humoral response after COVID19 vaccination

    Time frame: before first dose vaccination

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

  2. humoral response after COVID19 vaccination

    Time frame: before second dose vaccination

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

  3. humoral response after COVID19 vaccination

    Time frame: 3 months after vaccination

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

  4. humoral response after COVID19 vaccination

    Time frame: 6 months after vaccination

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

  5. humoral response after COVID19 vaccination

    Time frame: 12 months after vaccination

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

  6. clinical response after COVID19 vaccination

    Time frame: 12 months after vaccination

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

  7. security of mRNA COVID19 vaccine

    Time frame: 3 months after vaccination

    side effects onset in the follow-up

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cornouaille

Other

Registry information

Acronym: HEMVACO

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 21, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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