Improving immune function in older adults with a new immunomodulator
Assessment of QBKPN Site-Specific Immunomodulator (SSI) Efficacy in Improving Innate Immune Function and Reducing All-Cause Respiratory Tract Infection Morbidity in Adults 65 Years of Age or Older Residing in the Community, in Independent-Living, Assisted-Living and Long-term Care Facilities
This study is testing a new treatment called QBKPN to see if it can boost the immune system in older adults aged 65 and up and help them stay healthier, especially against respiratory infections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Qu Biologics Inc. Industry-sponsored |
| Drugs / interventions | rituximab, ibrutinib, imatinib, chemotherapy, radiation, methotrexate, prednisone |
| Locations | 1 site (Burnaby, British Columbia) |
| Trial ID | NCT05421325 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling or long-term care residents aged 65 years or older who can provide informed consent.
Not a fit: Patients with a life expectancy of less than 3 months or those on immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of respiratory infections and improve immune responses in older adults.
How similar studies have performed: While this approach is novel, similar immunomodulatory strategies have shown promise in enhancing immune function in older populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Burnaby, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.