Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-01 @ 1:57 AM
Study NCT ID:
NCT05074706
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
Sponsor:
University of Milano Bicocca
Organization:
Study Overview
Official Title:
Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hema-C19-Vax
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: