Hema-C19-Vax: Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine [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.
Secondary Outcome Measures
- To compare the seroconversion rate in haematological patients versus healthy subjects. [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.
- To correlate the rate of seroconversion in hematological patients to the specific haematological diseases. [Between 30 and 60 days after the administration of the second vaccine dose]
Rate of seroconversion per type of haematological condition
- To correlate the rate of seroconversion to previous therapies [Between 30 and 60 days after the administration of the second vaccine dose]
Rate of seroconversion per specific treatment.
- 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. [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
- 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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed and dated EC-approved informed consent
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Hematological disease defined according to World Health Organization (WHO) criteria
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Female or male, 18 years of age or older
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ECOG performance status 0-3
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Willingness and ability to comply with routine clinical practice and study procedures
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Regular vaccination against SARS-CoV-2 according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021).
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Routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up.
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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:
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Preventive vaccination against SARS-CoV-2 not administered according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021)
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Evidence of previous infection with the SARS-Cov-2 virus.
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Routine blood test not planned between 30 and 60 days after administration of the second vaccine dose.
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Routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | San Gerardo Hospital | Monza | Lombardia | Italy | 20900 |
Sponsors and Collaborators
- University of Milano Bicocca
- San Gerardo Hospital
Investigators
- Study Director: Carlo Gambacorti Passerini, Professor, San Gerardo Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hema-C19-Vax