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

Completed

• Conditions: Covid19; Cancer

• 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

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