A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study

A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study

This is a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched).

This study will be conducted on 7 cohorts of cancer patients and 1 cohort of non-cancer subjects (age and gender matched) with a sample size of 30 patients in each cohort:

All enrolled patients will be asked to provide blood samples (2 x 10cc Heparin Tubes) at the following time points:

• Baseline: before the administration of the first dose of the SARS-CoV-2 vaccine (within 4 weeks).
• Before the second dose of the SARS-CoV-2 vaccine (within 7 days).
• Follow-up: after 3, 6, 9 and 12 months after the second dose of the SARS-CoV-2 vaccine. A +/- 14 days window is allowed at each follow-up time point.

Inclusion Criteria:

• Male of Female age at least 18 years
• Patients with a diagnosis of malignancy (solid tumors or hematological malignancies) according to the defined cohorts. Only for cohorts 1-7
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Absence of known immune deficiency (other than cancer for cohorts 1-7)
• Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
• Willing and able to comply with the study procedures.
• Willing to receive an mRNA anti-SARS-CoV-2 vaccine.