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

NCT ID: NCT04800146

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-25
• Study Completion Date: 2023-03-21

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.

Conditions

Covid19; Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

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).

Blood sample

Intervention Type: PROCEDURE

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

Cohort 2

patients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment

Blood sample

Intervention Type: PROCEDURE

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

Cohort 3

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.

Blood sample

Intervention Type: PROCEDURE

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

Cohort 4

patients with previously untreated mature B cell tumors in watch and wait

Blood sample

Intervention Type: PROCEDURE

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

Cohort 5

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

Blood sample

Intervention Type: PROCEDURE

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

Cohort 6

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

Blood sample

Intervention Type: PROCEDURE

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

Cohort 7

patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months

Blood sample

Intervention Type: PROCEDURE

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

Cohort 8

non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2.

Blood sample

Intervention Type: PROCEDURE

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

Interventions

Blood sample

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Research in Biomedicine

UNKNOWN

Sponsor Role: collaborator

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role: collaborator

Ilaria Colombo

OTHER

Sponsor Role: lead

Responsible Party

Ilaria Colombo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oncology Institute of Southern Switzerland

Bellinzona, , Switzerland

Countries

Switzerland

Other Identifiers

IOSI-COVID19-001

Identifier Type: -

Identifier Source: org_study_id