Evaluating COVID-19 and influenza vaccine schedules for immunocompromised individuals

The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts

This study is testing different ways to give COVID-19 and flu vaccines to people with weakened immune systems to see which method works best for their protection.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 660 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 3 sites (Montreal, Quebec and 2 other locations)
• Trial ID: NCT06599658 on ClinicalTrials.gov

What this trial studies

This phase II interventional trial aims to assess the effectiveness of different vaccination schedules for COVID-19 and influenza in individuals with compromised immune systems. The study will compare the co-administration of the seasonal influenza vaccine with the latest COVID-19 booster against a sequential administration approach. Additionally, it will evaluate the impact of administering COVID-19 boosters at 3-month intervals versus 6-month intervals on long-term immune response. The trial is designed to improve vaccine immunogenicity and safety for people living with immunocompromising conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with immunocompromising conditions such as solid organ transplant recipients, individuals living with HIV, or those with inflammatory bowel disease or autoimmune diseases.

Not a fit: Patients who do not meet the inclusion criteria, such as those without immunocompromising conditions or those who have not received the primary COVID-19 vaccine series, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance vaccine effectiveness and safety for immunocompromised patients, reducing their risk of severe infections.

How similar studies have performed: Other studies have shown promising results in improving vaccine responses in immunocompromised populations, suggesting that this approach may be effective.

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

Where this trial is running

Montreal, Quebec and 2 other locations

• Maisonneuve -Rosemont Installation — Montreal, Quebec, Canada (RECRUITING)
• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (RECRUITING)
• Research Institute of McGill University Health Centre — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Ruth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC

Conditions: COVID 19, Influenza, Rheumatoid Arthritis, Systemic Lupus Erthematosus, Inflammatory Bowel Disease, Solid Organ Transplant Recipients, Immunocompromised Host, People Living With HIV