Recruiting
Phase 2

COVID-19 Booster

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06599658

Conditions

COVID 19

Influenza

Rheumatoid Arthritis (RA)

Systemic Lupus Erthematosus

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inactivated influenza vaccine (IIV) at baseline

COVID-19 Vaccines at a 3-month interval

Inactivated influenza vaccine at Month 1

COVID-19 Vaccines at a 6-month interval

Study Details

Brief summary:

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).

The main questions it aims to answer are:

1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?
2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?

Researchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.

People living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.

Conditions

COVID 19

Influenza

Rheumatoid Arthritis (RA)

Systemic Lupus Erthematosus

Inflammatory Bowel Disease

Study ID

NCT06599658

Start date

Nov 20, 2024

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1

Covid-19 booster every 3 months and Inactivated influenza vaccine (IIV) at baseline

experimental: Group 2

Covid-19 booster every 3 months and IIV at 1 month

experimental: Group 3

Covid-19 booster every 6 months and IIV at baseline

experimental: Group 4

Covid-19 booster every 6 months and IIV at 1 month

Interventions

Inactivated influenza vaccine (IIV) at baseline

National Advisory Committee on Immunization (NACI) recommended seasonal inactivated influenza vaccine for moderate to severely immunocompromised patients by age at baseline

COVID-19 Vaccines at a 3-month interval

Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 3-month interval

Inactivated influenza vaccine at Month 1

National Advisory Committee on Immunization (NACI) recommended seasonal inactivated influenza vaccine for moderate to severely immunocompromised patients by age 1-month following initial COVID-19 booster

COVID-19 Vaccines at a 6-month interval

Updated NACI recommended COVID-19 booster for moderate to severely immunocompromised patients at a 6-month interval

Primary outcome measure

  • Median neutralization capacity against prevalent SARS-CoV-2 variant [ Time Frame: At 1-month and 2-months following the initial COVID-19 booster dose for primary objective 1 and at 12-months and 6-months following initial COVID-19 booster dose for primary objective 2 ]

Central Contacts and Locations

Central contacts

Ruth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC

5149341934ruth.sapir-pichhadze.med@ssss.gouv.qc.ca

Locations

Maisonneuve -Rosemont Installation

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Lynne Senécal, MD

5142523400lynne.senecal.med@ssss.gouv.qc.ca

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Heloise Cardinal, MD PhD

514-890-8000heloise.cardinal.med@ssss.gouv.qc.ca

Research Institute of McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Ruth Sapir-Pichhadze, B.Med.Sc., MD, MSc, PhD, FRCPC

5149341934ruth.sapir-pichhadze.med@ssss.gouv.qc.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Keywords

  • Vaccine
  • Immunogenicity
  • Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-10.