COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the best ways to boost immunity against COVID-19 and influenza in adults with weakened immune systems. The researchers want to find out if giving the COVID-19 booster and flu vaccine together is just as effective as giving them one after the other. They also want to learn if giving the COVID-19 booster every three months helps maintain better protection compared to giving it every six months. The trial is open to adults aged 18 and older who have had three doses of the primary COVID-19 vaccine and have certain immunocompromising conditions, like being a solid organ transplant recipient, living with HIV, or having specific autoimmune diseases.

Participants will receive vaccines and have their blood tested to check how well their immune system is responding. They will also be monitored for any side effects and asked about their quality of life. The trial is currently recruiting participants, and it is important to note that those who have received certain vaccines recently or have specific health conditions may not be eligible to join. This trial aims to help improve vaccination strategies for those who need it most.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• - All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:
• • a) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\<200 cells/µL in the last 6 months, iv) CD4%\<15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.
• Exclusion Criteria:
• * Potential participants who meet ANY of the following criteria will be excluded:
• i. Received any of the following:
• • 1. Annual vaccination against influenza \< 6 months ago
• 2. COVID-19 booster \< 3 months ago ii. History of any of the following:
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• • 1. life-threatening reaction any component of the IIV or COVID-19 vaccines
• • 2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination
• • 3. Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \&lt; 6-months ago; vi. Unable to provide informed consent