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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800146
• Other study ID #: IOSI-COVID19-001
• Status: Completed
• Start date: February 25, 2021
• Est. completion date: March 21, 2023

Study information

• Verified date: March 2023
• Source: Oncology Institute of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona

Sponsors (3)

Lead Sponsor	Collaborator
Ilaria Colombo	Ente Ospedaliero Cantonale, Bellinzona, Institute for Research in Biomedicine

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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