Evaluation of the Immune Response to Sars-Cov-2 Vaccines in Haematological Patients: Prospective Single Center Study (Hema-C19-Vax)
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|ClinicalTrials.gov Identifier: NCT05074706|
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 12, 2021
|Condition or disease||Intervention/treatment|
|Hematologic Diseases||Biological: IgG antibodies to Sars-Cov-2 Biological: QuantiFERON SARS-CoV-2 test|
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|
|Estimated Enrollment :||700 participants|
|Official Title:||Evaluation of the Immune Response to Sars-Cov-2 Vaccines in Haematological Patients: Prospective Single Center Study|
|Actual Study Start Date :||June 9, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
- Biological: IgG antibodies to Sars-Cov-2
Samples will be collected between 30 and 60 days after second vaccine dose.Other Name: Blood serum SARS-CoV-2 IgG
- Biological: QuantiFERON SARS-CoV-2 test
Samples will be collected within 9 months after completion of the vaccination seriesOther Name: Plasma INF-γ
- 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.
- 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.
- 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
- 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.
- 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
- 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074706
|Contact: Elisa Bossi, MD||+39 email@example.com|
|Contact: Andrea Aroldi, M.Sc||+39 039 firstname.lastname@example.org|
|Study Director:||Carlo Gambacorti Passerini, Professor||San Gerardo Hospital|