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

Completed

• Conditions: Cancer; COVID-19

• Registration Number: NCT05062525
• Lead Sponsor: University Health Network, Toronto

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 Timeline

• Study Start: 2021-09-28
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-09-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of SARS-CoV-2 antibodies	15 months
Number of immune-related adverse events	15 months

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada