Covid-19 Clinical Trial
Official title:
Prospective, Cohort, Non-interventional, Single-center Clinical Study of Immune Response Status to SARS-CoV-2 / Covid-19 Vaccination in Patients With Haematological Malignancies.
Verified date | May 2021 |
Source | Ospedale di Circolo - Fondazione Macchi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Covid-19 is associated with a mortality rate of 33-37% in patients with hematological malignancies. At present, the anti-SARS-CoV-2 vaccination represents the most effective strategy for the prevention of Covid-19. Patients with malignancies were excluded from the trials leading to the approval of Comirnaty, Moderna, Vaxzevria and Janssen vaccines. The immunogenicity of these vaccines in immunocompromised patients or with hematological malignancies is an unmet clinical need. The aim of the study is to evaluate the efficacy of vaccination in adult patients with hematological malignancies, who received vaccination according to Italian rules and were in treatment at the Hematology Unit of Varese, Italy Efficacy will be evaluated in terms of serological response, cellular-mediated immune response and prevention of Covid-19. The duration of the study will be 24 months.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | April 30, 2023 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years. - History of hematological neoplasia (myeloid neoplasms, lymphoid neoplasms, plasma cell dyscrasias). - Active hematological neoplasm. Exclusion Criteria: - Hematological diseases, other than hematological malignancies. |
Country | Name | City | State |
---|---|---|---|
Italy | UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi | Varese | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Ospedale di Circolo - Fondazione Macchi |
Italy,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination. | The percentage of patients with positive antibody titer (= 12 AU / mL) after at least 28 days from vaccination. | 1 month after completion of vaccination | |
Secondary | To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the disease and its status. | The percentage of patients with positive antibody titer (= 12 AU / mL) after at least 28 days from vaccination in myeloid, lymphoid and plasma cell dyscrasias sub-categorized by status of disease, status and type of treatment. | 1 month after completion of vaccination | |
Secondary | To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination according to the type of vaccination. | The percentage of patients with positive antibody titer (= 12 AU / mL) after at least 28 days from vaccination described by vaccine brand (currently Comirnaty, Moderna, Vaxzevria, Janssen). | 1 month after completion of vaccination | |
Secondary | To assess the antibody titer at least 28 days after the SARS-CoV-2 / Covid-19 vaccination. | The distribution and median of the antibody titer at least 28 days after vaccination. | 1 month after completion of vaccination | |
Secondary | To evaluate the persistence of the antibody titer after vaccination. | The difference between the antibody titer at 28 days and at 6 and 12 months after vaccination. | 28 days, 6 and 12 months after completion of vaccination | |
Secondary | To evaluate the cellular immune response to SARS-CoV-2 / Covid-19 vaccination. | The percentage of patients who generated immune cells with IFN-gamma cytokine response after at least 28 days, 6 and 12 months after vaccination. | 28 days, 6 and 12 months after completion of vaccination | |
Secondary | To evaluate the clinical efficacy of the anti SARS-CoV-2 / Covid-19 vaccination. | The percentage of patients with any among: 1) positive molecular swab by RT-PCR, 2) documented symptomatic Covid-19 disease; 3) hospitalization for Covid-19; 4) documented severe Covid-19 disease; 5) death from Covid-19 despite vaccination. | 28 days, 6 and 12 months after completion of vaccination |
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