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Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies

NCT04878822 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2021-09-13

No results posted yet for this study

Summary

Covid-19 is associated with a mortality rate of 33-37% in patients with hematological malignancies.

At present, the anti-SARS-CoV-2 vaccination represents the most effective strategy for the prevention of Covid-19. Patients with malignancies were excluded from the trials leading to the approval of Comirnaty, Moderna, Vaxzevria and Janssen vaccines. The immunogenicity of these vaccines in immunocompromised patients or with hematological malignancies is an unmet clinical need.

The aim of the study is to evaluate the efficacy of vaccination in adult patients with hematological malignancies, who received vaccination according to Italian rules and were in treatment at the Hematology Unit of Varese, Italy Efficacy will be evaluated in terms of serological response, cellular-mediated immune response and prevention of Covid-19.

The duration of the study will be 24 months.

Conditions

Sponsors & Collaborators

  • Ospedale di Circolo - Fondazione Macchi

    lead OTHER

Principal Investigators

  • Francesco Passamonti, MD · Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2021-07-31
Completion
2023-04-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878822 on ClinicalTrials.gov