Improving immune function in older adults with a new immunomodulator

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 clinical trial evaluates the efficacy of QBKPN, a site-specific immunomodulator, in enhancing innate immune function among older adults aged 65 and above. The study is randomized, double-blind, and placebo-controlled, involving participants from community settings and long-term care facilities. Over a period of 26 weeks, participants will receive either the QBKPN treatment or a placebo, with various immunological assessments conducted to measure the impact on respiratory infections and overall health. The trial aims to determine if QBKPN can improve immune responses, particularly in relation to COVID-19 vaccinations and general quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be a resident of the community or a long-term care, independent-living or assisted living facility participating in the study
2. Be aged 65 years or older
3. Be able to provide written, informed consent themselves
4. Male subjects engaged in vaginal intercourse with women of childbearing potential must be surgically sterile or agree to practice effective barrier contraception during the entire study treatment period (4 weeks) and one month after the last dose of study drug or agree to completely abstain from vaginal intercourse with women of childbearing potential during this period.

Exclusion Criteria:

1. Life expectancy of less than 3 months due to terminal illness as determined by the Study Investigator
2. Taking biologic immunosuppressive agents (e.g., Anti-Tumour Necrosis Factor Alpha (anti-TNFa) antibodies, rituximab, ibrutinib, imatinib) calcineurin inhibitors, myelosuppressants (e.g., methotrexate, mycophenolate), or other systemic immunosuppressants. Note: NSAIDs, colchicine, aspirin and oral glucocorticoids at a dose equivalent to less than or equal to 5mg prednisone per day are allowed
3. Currently being treated or less than 30 days from being treated for confirmed or probable infection with systemic (i.e., not topical) antibiotics or antivirals
4. Have a known allergy or hypersensitivity to killed whole-cell bacterial vaccines
5. Any condition that, in the opinion of the Investigator, would preclude the person from participation in the study due to safety or monitoring concerns
6. Any treatment with experimental or investigational therapies within 3 months prior to Screening and/or any planned treatment with experimental or investigational therapies during the entire course of study participation
7. On current treatment for active malignancies (e.g., chemotherapy, radiation) or planned cancer surgery during the study period. Note: People on exclusively hormonal therapy for breast or prostate cancer are allowed. People with prior or planned surgery for localized squamous cell or basal cell carcinoma of the skin are allowed

Where it's running

• Qu Biologics Trial Site
  Burnaby, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Theodore Steiner, MD FRCPC — University of British Columbia
• Study coordinator: Oksana Korolova, Director, Clinical Operations
• Email: okorolova@qubiologics.com
• Phone: 236-512-3119

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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.