Clinical trial NCT04800146: A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
Official title: A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Cancer
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Institute for Research in Biomedicine
name: Ente Ospedaliero Cantonale, Bellinzona
First posted: 2021-03-16
Enrollment: 177
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this study is represented by patients with a diagnosis of solid tumor or hematological malignancy and receiving treatment or on active surveillance at the IOSI who have planned to receive an mRNA (messenger ribonucleic acid) SARS-CoV-2 vaccine, according to the prespecified cohorts.

A control group of non-cancer subjects followed at the outpatient clinic of the Division of Infectious Diseases, EOC will also be enrolled for comparative analysis.

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.

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.

Primary outcomes:
measure: Immune response to SARS-CoV-2 vaccine in cancer patients
timeFrame: 3, 6, 9 and 12 months following vaccination
Secondary outcomes:
measure: changes in serum antibodies anti SARS-CoV-2 after vaccination
timeFrame: 3, 6, 9 and 12 months following vaccination
measure: Cellular immune response to SARS-CoV-2 vaccine
timeFrame: 3, 6, 9 and 12 months following vaccination
measure: Cellular immune response to SARS-CoV-2 vaccine
timeFrame: 3, 6, 9 and 12 months following vaccination
measure: Immune response to SARS-CoV-2 vaccine according tumor and treatment type
timeFrame: 3, 6, 9 and 12 months following vaccination
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
Study officials:
References: