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

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ClinicalTrials.gov Identifier: NCT04800146
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Collaborators:
Institute for Research in Biomedicine
Ente Ospedaliero Cantonale, Bellinzona
Information provided by (Responsible Party):
Ilaria Colombo, Oncology Institute of Southern Switzerland

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).

Condition or disease Intervention/treatment
Covid19 Cancer Procedure: Blood sample

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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 30, 2022

Group/Cohort Intervention/treatment
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).
Procedure: Blood sample
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
Procedure: Blood sample
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.
Procedure: Blood sample
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
Procedure: Blood sample
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
Procedure: Blood sample
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
Procedure: Blood sample
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
Procedure: Blood sample
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.
Procedure: Blood sample
Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination




Primary Outcome Measures :
  1. Immune response to SARS-CoV-2 vaccine in cancer patients [ Time Frame: 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 :
  1. changes in serum antibodies anti SARS-CoV-2 after vaccination [ Time Frame: 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

  2. Cellular immune response to SARS-CoV-2 vaccine [ Time Frame: 3, 6, 9 and 12 months following vaccination ]
    To explore the dynamic changes overtime of the T cells immune response following SARS-CoV-2 vaccination in cancer patients and controls.

  3. Cellular immune response to SARS-CoV-2 vaccine [ Time Frame: 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.

  4. Immune response to SARS-CoV-2 vaccine according tumor and treatment type [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800146


Locations
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Switzerland
Oncology Institute of Southern Switzerland Recruiting
Bellinzona, Switzerland, 6500
Contact: ilaria colombo, MD    +41764528823    ilaria.colombo@eoc.ch   
Sponsors and Collaborators
Ilaria Colombo
Institute for Research in Biomedicine
Ente Ospedaliero Cantonale, Bellinzona
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Responsible Party: Ilaria Colombo, Principal Investigator, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT04800146    
Other Study ID Numbers: IOSI-COVID19-001
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No