Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
NCT ID: NCT05074706
Last Updated: 2023-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
700 participants
OBSERVATIONAL
2021-06-09
2022-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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IgG antibodies to Sars-Cov-2
Samples will be collected between 30 and 60 days after second vaccine dose.
QuantiFERON SARS-CoV-2 test
Samples will be collected within 9 months after completion of the vaccination series
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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San Gerardo Hospital
OTHER
University of Milano Bicocca
OTHER
Responsible Party
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Principal Investigators
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Carlo Gambacorti Passerini, Professor
Role: STUDY_DIRECTOR
San Gerardo Hospital
Locations
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San Gerardo Hospital
Monza, Lombardy, Italy
Countries
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Other Identifiers
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Hema-C19-Vax
Identifier Type: -
Identifier Source: org_study_id
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