Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05062525
Acronym
VIVACIOUS
Enrollment
53
Registered
2021-09-30
Start date
2021-09-28
Completion date
2021-09-28
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, COVID-19

Keywords

COVID-19 Vaccine

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.

Interventions

None listed

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Concentration of SARS-CoV-2 antibodies15 months
Number of immune-related adverse events15 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026