Evaluating COVID-19 and influenza vaccine schedules for immunocompromised individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre hospitalier de l'Université de Montréal (CHUM)
  Montreal, Quebec, Canada Recruiting
• Research Institute of McGill University Health Centre
  Montreal, Quebec, Canada Recruiting
• Maisonneuve -Rosemont Installation
  Montreal, Quebec, Canada Active not recruiting

Study contacts

• Study coordinator: Ruth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC
• Email: ruth.sapir-pichhadze.med@ssss.gouv.qc.ca
• Phone: 5149341934

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.