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NCT05062525 Clinical Trial

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

Cancer Clinical Trial

— VIVACIOUS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05062525
Other study ID # VIVACIOUS
Secondary ID 21-5797
Status Completed
Phase
First received
Last updated
Start date September 28, 2021
Est. completion date September 28, 2021

Study information
Verified date May 2023
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date September 28, 2021
Est. primary completion date September 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Princess Margaret Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of SARS-CoV-2 antibodies 15 months
Primary Number of immune-related adverse events 15 months
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