Cancer, Covid19
Conditions
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREBlood sample
Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination
Sponsors
Institute for Research in Biomedicine
Ente Ospedaliero Cantonale, Bellinzona
Ilaria Colombo
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response to SARS-CoV-2 vaccine in cancer patients | 3, 6, 9 and 12 months following vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in serum antibodies anti SARS-CoV-2 after vaccination | 3, 6, 9 and 12 months following vaccination | To explore the dynamic changes overtime of the levels of antibodies against SARS-CoV-2 following vaccination in cancer patients and controls |
| Cellular immune response to SARS-CoV-2 vaccine | 3, 6, 9 and 12 months following vaccination | To explore the dynamic changes overtime of the T cells immune response following SARS-CoV-2 vaccination in cancer patients and controls. |
| Immune response to SARS-CoV-2 vaccine according tumor and treatment type | 3, 6, 9 and 12 months following vaccination | To explore the correlation between the immune response against SARS-CoV-2 vaccination and the type of cancer (e.g., solid tumors versus hematological malignancies) and the type of anticancer treatment (e.g., anti-CD20, chemotherapy, targeted agents, immunotherapy, allogenic or autologous transplant) |
Countries
Switzerland
Outcome results
None listed