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

Ilaria Colombo177 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

177

Conditions

Covid19 Cancer

Interventions

Blood samplePROCEDURE

Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Oncology Institute of Southern Switzerland

Bellinzona, Switzerland

Outcomes

Primary Outcomes

Immune response to SARS-CoV-2 vaccine in cancer patients

to determine the changes in the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens in 7 cohorts of cancer patients who have received the SARS-CoV-2 vaccination. A cohort of non-cancer subjects will be used as control group.