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

Completed

• Conditions: Covid19; Cancer
• Interventions: Procedure: Blood sample

• Registration Number: NCT04800146
• Lead Sponsor: Ilaria Colombo

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.

Study Timeline

• Study Start: 2021-02-25
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-13
• Study First Posted: 2021-03-16
• Status Verified: 2023-03
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Blood sample	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).
Cohort 2	Blood sample	patients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment
Cohort 3	Blood sample	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.
Cohort 4	Blood sample	patients with previously untreated mature B cell tumors in watch and wait
Cohort 5	Blood sample	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
Cohort 6	Blood sample	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
Cohort 8	Blood sample	non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2.
Cohort 7	Blood sample	patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 B 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)

Trial Locations

Locations (1)

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland