Trials / Completed
CompletedNCT05074706
Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 700 (actual)
- Sponsor
- University of Milano Bicocca · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IgG antibodies to Sars-Cov-2 | Samples will be collected between 30 and 60 days after second vaccine dose. |
| BIOLOGICAL | QuantiFERON SARS-CoV-2 test | Samples will be collected within 9 months after completion of the vaccination series |
Timeline
- Start date
- 2021-06-09
- Primary completion
- 2022-06-15
- Completion
- 2022-06-15
- First posted
- 2021-10-12
- Last updated
- 2023-01-25
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05074706. Inclusion in this directory is not an endorsement.