Hematologic Diseases
Conditions
Keywords
serocoversion, COVID vaccination, cellular immunity, Sars-Cov-2 IgG antibodies, QuantiFERON-SARS-CoV-2 test
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
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.
Interventions
BIOLOGICALIgG antibodies to Sars-Cov-2
Samples will be collected between 30 and 60 days after second vaccine dose.
BIOLOGICALQuantiFERON SARS-CoV-2 test
Samples will be collected within 9 months after completion of the vaccination series
Sponsors
San Gerardo Hospital
University of Milano Bicocca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed