VIVACIOUS: Immune Response to COVID-19 Vaccine in Immunotherapy (IO) and Non-IO Treated Cancer Patients

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT05062525
Collaborator
(none)
53
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Evaluation of antibody response against SARS-CoV-2 vaccination in patients treated with IO-treatment, in comparison with antibody titers in patients treated with non-IO treatment.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Blood samples will be analyzed to determine the magnitude of SARS-CoV-2 immunity in cancer patients treated with immunotherapy by quantifying antibodies and other tumor or blood-based biomarkers against SARS-CoV-2 epitopes following vaccination. We will also explore for potential development of autoantibodies and other blood-based biomarkers, following SARS-CoV-2 vaccination, and their correlation with clinical manifestation of IO related immune-related adverse events.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Immune Response to COVID-19 Vaccine in Immunotherapy (IO) and Non-IO Treated Cancer Patients
    Actual Study Start Date :
    Sep 28, 2021
    Actual Primary Completion Date :
    Sep 28, 2021
    Actual Study Completion Date :
    Sep 28, 2021

    Arms and Interventions

    ArmIntervention/Treatment
    Immunotherapy

    Non-Immunotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of SARS-CoV-2 antibodies [15 months]

    2. Number of immune-related adverse events [15 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients with solid malignancies treated with either IO or non-IO treatment.

    2. All categories of IO treatment allowed (immune-checkpoint inhibitors, bi-specific T cell engagers, cytokine agonists and others), as well as all categories of non-IO treatment (such as chemotherapy and targeted therapies). These can be given as part of standard of care or within participation in a clinical trial.

    3. Patients are allowed to have any of the approved vaccines in Canada, such as Pfizer, Moderna, AstraZeneca or their approved combinations.

    4. Patients must receive all appropriate doses of SARS-CoV-2 vaccination, as dictated by the respective vaccine schedules.

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Princess Margaret HospitalTorontoOntarioCanadaM5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT05062525
    Other Study ID Numbers:
    • VIVACIOUS
    • 21-5797
    First Posted:
    Sep 30, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Health Network, Toronto
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021