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COVID-19 Vaccine Immunogenicity and Safety in Immunodeficient Patients – VISID study

What is the purpose of this study?

Vaccine efficacy data from reported clinical trials are not applicable to immunocompromised patients, as those who are immunocompromised are excluded from clinical trial testing.  In addition, the extent of immune response to COVID-19 vaccines, which are produced by many new technology platforms such as mRNA and viral vector-based vaccines, in immunocompromised patients is not known. Understanding immune response, real-world vaccine effectiveness, as well as safety profile in these patients is warranted. This research area is also a NACI research priority.

This observational study will measure vaccine immunogenicity and safety in non-HIV, non-transplant immunocompromised patients. Studying patients with different immune defects will help increase understanding of the roles of each immune compartment in COVID-19 vaccine responses.

Am I eligible to be part of this study?

Both immunocompromised and healthy individuals are needed for this study. To capture patients who had received at least one dose of COVID-19 vaccine, we will divide our study population into vaccine naïve (have not received any COVID-19 vaccinations) and vaccine experienced (have received at least one or both COVID-19 vaccination) groups. Within each group, there will be three subgroups based on the type of immunodeficiencies detailed in the inclusion criteria below.  You may be eligible for this study if you:

  • Are eligible for COVID-19 vaccination according to Health Canada
  • Able to provide informed consent
  • Able to speak either English or French
  • Available for ongoing follow-up as required
  • Satisfy at least one of the following conditions:
    • Subgroup A
      • Primary antibody deficiency diagnosis according to the 2019 International Union of Immunological Societies classification11, including but not limited to common variable immunodeficiency and x-linked agammaglobulinemia
      • Being treated or recently treated (< 6 months) with B-cell depleting therapy (e.g. rituximab, ocrelizumab) or with B-cell activating factor inhibitor (e.g. belimumab), including patients with immune-mediated diseases such as multiple sclerosis, rheumatoid arthritis, and granulomatous polyangiitis as well as patients with hematological malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia
    • Subgroup B
      • Combined B-cell and T-cell immunodeficiency diagnosis according to the     2019 International Union of Immunological Societies classification
    • Subgroup C
      • Primary innate immune defect, including but not limited to non-transplanted chronic granulomatous disease, complement deficiency, and presence of autoantibodies to cytokines

What will I have to do?

Vaccine administration:

Participants and healthy controls will receive one of the following mRNA-based vaccine from Pfizer-BioNTech or mRNA-based vaccine from Moderna. 

Blood sample collection:

20-30mL of blood will be drawn for research from each participant at the following five timepoints in vaccine naïve group: 0-28 days before first dose, >21 days after the first vaccination and £7 days before the second dose, approximately 7 days before the third dose, 4(±1) weeks, and 24(±1) weeks after the third dose. For healthy participants who are not eligible for the third dose, 48(±4) weeks after the second dose will be collected. Please note that the timing of third dose can be different from one province to another, but generally is 8-24 weeks after the second dose.

Contact Hannah Munday

Phone (902) 478-7267


Find out more about this study

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