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 this patient population was excluded. 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, is not known. Understanding immune response and real-world vaccine effectiveness as well as safety profile in these patients is warranted. This research area is also a National Advisory Committee on Immunization (NACI) research priority.
This observational study will measure vaccine immunogenicity and safety in non-HIV, immunocompromised patients. Studying patients with different immune defects will help increase the 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 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
- Are able to provide informed consent or consent of an SDM (substitute decision maker)
- Are able to speak either English or French
- Are available for ongoing follow-up as required
- Satisfy at least one of the following conditions:
- Primary antibody deficiency diagnosis according to the 2019 International Union of Immunological Societies classification, including but not limited to common variable immunodeficiency and x-linked agammaglobulinemia
- Being treated or recently treated (< 12 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
- Combined B-cell and T-cell immunodeficiency diagnosis according to the 2019 International Union of Immunological Societies classification
- Primary innate immune defect, including but not limited to non-transplanted chronic granulomatous disease, complement deficiency, diseases of immune dysregulation, autoinflammatory disorders, and presence of autoantibodies to cytokines
For vaccine experienced group the following criteria are required:
- Previous vaccination(s) with Pfizer-BioNTech Comirnaty, Moderna Spikevax or AstraZeneca Vaxzevria vaccine only
- In case of full vaccination before study enrollment, less than 24 weeks have passed after the last dose
For healthy controls, you may eligible if you are:
- An immunocompetent individual eligible for COVID-19 vaccination according to Health Canada
- Able to provide informed consent or consent of an SDM (substitute decision maker)
- Able to speak either English or French
- Available for ongoing follow-up as required
What will I have to do?
Blood sample collection:
20 – 30mL of blood will be drawn for research from each participant at 4 – 5 time points. Please note that the total number of visits with blood draws will vary depending on at which time point you enroll.
Safety data collection:
To harmonize data safety collection with other national networks, participants will be asked to complete a secured web-based survey at 1 and 4 weeks following each vaccine dose to capture medically-attended Adverse Events Following Immunization (AEFIs). Participants will also be asked to retrospectively complete a survey for each dose received prior to their enrollment in the study.
Contact Pam MacIntyre
Phone (902) 470-8948