Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study (Hema-C19-Vax)

January 23, 2023 updated by: University of Milano Bicocca

Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study

The main objective of this study is to investigate the humoral immune response to COVID-19 vaccines in haematological patients, by testing SARS-CoV-2 seroconversion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-center prospective study will enroll approximately 700 hematologic patients who access to Haematological Division (San Gerardo Hospital, Monza, Italy) in order to perform their routine blood tests to monitor their hematological conditions. Evaluation of Sars-Cov-2 IgG specific antibodies will be performed on left-over biological material (serum or plasma) collected during routine blood tests run between 30 and 60 days after the administration of the second vaccine dose.

Furthermore, in each patient who has failed seroconversion (absence of specific antibodies for circulation), his cellular immune response will be assessed using an additional blood sample collected during routine blood tests.

These samples will be collected within 9 months of the completion of the vaccination series and will be used to evaluate the plasma INF-γ release using QuantiFERON SARS-CoV-2 test.

Study Type

Observational

Enrollment (Actual)

700

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
      • Monza, Lombardia, Italy, 20900
        • San Gerardo Hospital

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

Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy

Description

Inclusion Criteria:

  • Signed and dated EC-approved informed consent
  • Hematological disease defined according to World Health Organization (WHO) criteria
  • Female or male, 18 years of age or older
  • ECOG performance status 0-3
  • Willingness and ability to comply with routine clinical practice and study procedures
  • Regular vaccination against SARS-CoV-2 according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021).
  • Routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up.
  • Routine blood test planned no later than 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).

Exclusion Criteria:

  • Preventive vaccination against SARS-CoV-2 not administered according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021)
  • Evidence of previous infection with the SARS-Cov-2 virus.
  • Routine blood test not planned between 30 and 60 days after administration of the second vaccine dose.
  • Routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine
Time Frame: Between 30 and 60 days after the administration of the second vaccine dose
Seroconversion is defined as a post-vaccination SARS-CoV-2 IgG antibody titer >33.8 Binding Anticorpal Unit (BAU)/ml.
Between 30 and 60 days after the administration of the second vaccine dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the seroconversion rate in haematological patients versus healthy subjects.
Time Frame: Between 30 and 60 days after the administration of the second vaccine dose
Time adjusted rate of seroconversion after vaccination in hematological patient and healthy population.
Between 30 and 60 days after the administration of the second vaccine dose
To correlate the rate of seroconversion in hematological patients to the specific haematological diseases.
Time Frame: Between 30 and 60 days after the administration of the second vaccine dose
Rate of seroconversion per type of haematological condition
Between 30 and 60 days after the administration of the second vaccine dose
To correlate the rate of seroconversion to previous therapies
Time Frame: Between 30 and 60 days after the administration of the second vaccine dose
Rate of seroconversion per specific treatment.
Between 30 and 60 days after the administration of the second vaccine dose
To assess the efficacy of vaccine by estimating how many patients will be infected by SARS-CoV-2 in the 9 months after the administration of the second vaccine dose.
Time Frame: Within 9 months after the administration of the second vaccine dose
Rate of patients with a positive RT-PCR-SARS-CoV-2 test in the 9 months after the administration of the second vaccine dose
Within 9 months after the administration of the second vaccine dose
To analize T-cell response in those patients who will result negative for specific antibodies anti-Sars-Cov-2 after two doses of mRNA SARS-Cov-2 vaccination
Time Frame: Within 9 months after the administration of the second vaccine dose
Rate of patients with a positive QuantiFERON-SARS-CoV-2 test after the demonstration of seroconversion failure until the end of the study
Within 9 months after the administration of the second vaccine dose

Collaborators and Investigators

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

Sponsor

University of Milano Bicocca

Collaborators

San Gerardo Hospital

Investigators

  • Study Director: Carlo Gambacorti Passerini, Professor, San Gerardo Hospital

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)

June 9, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hema-C19-Vax

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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