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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Cancer

Intervention / Treatment
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* Procedure: Blood sample


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>patients with solid tumors treated with chemotherapy (ongoing or completed no more than 6 months before enrollment). Specific type of chemotherapy inducing similar immunosuppression will be selected (including but not limited to platinum-based combinations, anthracycline combinations, triweekly docetaxel). | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 2<br>patients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 3<br>patients with solid tumors treated with hormonal agents (ongoing or completed no more than 6 months before enrollment): any anti-androgen for prostate cancer and any anti-estrogen for breast cancer patients. | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 4<br>patients with previously untreated mature B cell tumors in watch and wait | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 5<br>patients with mature B cell tumors treated with anti-CD20 monoclonal antibody either alone or in combination with chemotherapy (ongoing or completed no more than 12 months before enrollment | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 6<br>patients with hematological malignancies treated with pathway inhibitors (ongoing or completed no more than 12 months before enrollment). Different type of targeted agents can be considered, including Bruton tyrosine kinase (BTK) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors or phosphoinositide-3 kinase (PI3K) inhibitors | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 7<br>patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|
| Cohort 8<br>non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2. | Procedure: Blood sample<br>* Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3, 6, 9 and 12 months following vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in serum antibodies anti SARS-CoV-2 after vaccination | To explore the dynamic changes overtime of the levels of antibodies against SARS-CoV-2 following vaccination in cancer patients and controls | 3, 6, 9 and 12 months following vaccination | 
| Cellular immune response to SARS-CoV-2 vaccine | To explore the dynamic changes overtime of the T cells immune response following SARS-CoV-2 vaccination in cancer patients and controls. | 3, 6, 9 and 12 months following vaccination | 
| Cellular immune response to SARS-CoV-2 vaccine | To explore the dynamic changes overtime of the B cells immune response following SARS-CoV-2 vaccination in cancer patients and controls. | 3, 6, 9 and 12 months following vaccination | 
| Immune response to SARS-CoV-2 vaccine according tumor and treatment type | 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) | 3, 6, 9 and 12 months following vaccination |