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

NCT05062525 | Completed

• 2 other identifiers: VIVACIOUS21-5797
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Cancer

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Concentration of SARS-CoV-2 antibodies

  15 months

• Number of immune-related adverse events

  15 months

Study Arms (2)

Immunotherapy

Non-Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with solid malignancies treated with either immunotherapy or non-immunotherapy treatment who have received the SARS-CoV-2 vaccination.

You may qualify if:

• Patients with solid malignancies treated with either IO or non-IO treatment.
• 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.
• Patients are allowed to have any of the approved vaccines in Canada, such as Pfizer, Moderna, AstraZeneca or their approved combinations.
• Patients must receive all appropriate doses of SARS-CoV-2 vaccination, as dictated by the respective vaccine schedules.

You may not qualify if:

• None

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: September 30, 2021
• Study Start: September 28, 2021
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

CA (1)