Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies

September 10, 2021 updated by: Francesco Passamonti, Ospedale di Circolo - Fondazione Macchi

Prospective, Cohort, Non-interventional, Single-center Clinical Study of Immune Response Status to SARS-CoV-2 / Covid-19 Vaccination in Patients With Haematological Malignancies.

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Covid-19 is associated with a mortality rate of 33-37% in patients with hematological malignancies (Passamonti et al, 2020; Garcia-Suarez et al, 2020). Currently, there is little information on the serological response following SARS-Cov-2 infection in this specific population.

At present, the anti-SARS-CoV-2 vaccination represents the most effective strategy for the prevention of Covid-19. The anti-SARS-CoV-2 vaccines currently approved by the European Medicines Agency (EMA) and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) are: the BNT162b2 SARS-Cov-2 (Pfizer-BioNTech, Comirnaty) vaccine, the mRNA-1273 SARS-Cov-2 (Moderna) vaccine, the ChAdOx1 nCoV-19 (Vaxzevria) vaccine, and the Ad26.COV2.S (Janssen) vaccine.

The double-dose regimen of Pfizer-BioNTech vaccine showed 95% efficacy at preventing Covid-19 (Polack et al, 2020), the double-dose regimen of Moderna vaccine showed 94.1% efficacy (Baden et al, 2021), the double-dose regimen of Vaxzevria vaccine showed 70.4% efficacy (Voysey et al, 2021), while the single-dose regimen of Janssen vaccine was found to be 66.1% effective (Sadoff et al, 2021).

The Italian national Covid-19 vaccination plan included patients with active malignancies in the second priority group, recognizing the importance of protecting this vulnerable population from SARS-Cov-2 infection. Since vaccine clinical trials excluded patients with malignancies and patients undergoing immunosuppressive therapies, the immunological response to anti-SARS-CoV-2 vaccines in these patients is currently unknown.

In this prospective, cohort, non-interventional study, our objective is to evaluate both the humoral and the cellular immune response to anti-SARS-CoV-2 vaccination in adults with hematological malignancies. For each patient the immune response will be evaluated after a minimum of 28 days from the completion of the vaccination regimen. Then, it will be reassessed after 6 and 12 months. In our center, the humoral immune response will be assessed by using the DiaSorin's LIAISON SARS-CoV-2 S1/S2 IgG test, which quantifies the level of anti-SARS-CoV-2 IgG antibodies that are active against the S1 and S2 subunits of the S protein. The cell-mediated immune response will be assessed on peripheral blood cells through a phenotypic and functional analysis by flow cytometry and through the ELISPOT test. Each patients will sign an informed consensus for the participation. The total duration of the study will be 24 months.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Varese, Lombardia, Italy, 21100
        • UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with hematological malignancies who have received the anti-SARS-CoV2 / Covid-19 vaccination, with or without previous Covid-19.

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • History of hematological neoplasia (myeloid neoplasms, lymphoid neoplasms, plasma cell dyscrasias).
  • Active hematological neoplasm.

Exclusion Criteria:

  • Hematological diseases, other than hematological malignancies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination.
Time Frame: 1 month after completion of vaccination
The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination.
1 month after completion of vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the disease and its status.
Time Frame: 1 month after completion of vaccination
The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination in myeloid, lymphoid and plasma cell dyscrasias sub-categorized by status of disease, status and type of treatment.
1 month after completion of vaccination
To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the type of vaccination.
Time Frame: 1 month after completion of vaccination
The percentage of patients with positive antibody titer (≥ 12 AU / mL) after at least 28 days from vaccination described by vaccine brand (currently Comirnaty, Moderna, Vaxzevria, Janssen).
1 month after completion of vaccination
To assess the antibody titer at least 28 days after the SARS-CoV-2 / Covid-19 vaccination.
Time Frame: 1 month after completion of vaccination
The distribution and median of the antibody titer at least 28 days after vaccination.
1 month after completion of vaccination
To evaluate the persistence of the antibody titer after vaccination.
Time Frame: 28 days, 6 and 12 months after completion of vaccination
The difference between the antibody titer at 28 days and at 6 and 12 months after vaccination.
28 days, 6 and 12 months after completion of vaccination
To evaluate the cellular immune response to SARS-CoV-2 / Covid-19 vaccination.
Time Frame: 28 days, 6 and 12 months after completion of vaccination
The percentage of patients who generated immune cells with IFN-gamma cytokine response after at least 28 days, 6 and 12 months after vaccination.
28 days, 6 and 12 months after completion of vaccination
To evaluate the clinical efficacy of the anti SARS-CoV-2 / Covid-19 vaccination.
Time Frame: 28 days, 6 and 12 months after completion of vaccination
The percentage of patients with any among: 1) positive molecular swab by RT-PCR, 2) documented symptomatic Covid-19 disease; 3) hospitalization for Covid-19; 4) documented severe Covid-19 disease; 5) death from Covid-19 despite vaccination.
28 days, 6 and 12 months after completion of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale di Circolo - Fondazione Macchi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

July 31, 2021

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImmunoHaema-COVID-VAX-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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