VIVACIOUS: Immune Response to COVID-19 Vaccine in Immunotherapy (IO) and Non-IO Treated Cancer Patients
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.
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Immunotherapy
|
|
Non-Immunotherapy
|
Outcome Measures
Primary Outcome Measures
- Concentration of SARS-CoV-2 antibodies [15 months]
- Number of immune-related adverse events [15 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with solid malignancies treated with either IO or non-IO treatment.
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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.
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Patients are allowed to have any of the approved vaccines in Canada, such as Pfizer, Moderna, AstraZeneca or their approved combinations.
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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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIVACIOUS
- 21-5797