Status:
RECRUITING
Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults
Lead Sponsor:
Qu Biologics Inc.
Collaborating Sponsors:
The National Research Council of Canada Industrial Research Assistance Program
Conditions:
Immune Deficiency
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This study is designed to test whether QBKPN SSI can improve immune function in older adults, including how well it can protect against respiratory and other infections, whether it improves the body's...
Detailed Description
This is a randomized, double-blind, placebo-controlled study of adults 65 years of age or older residing in the community, in independent-living, assisted-living and long-term care (LTC) facilities to...
Eligibility Criteria
Inclusion
- Be a resident of the community or a long-term care, independent-living or assisted living facility participating in the study
- Be aged 65 years or older
- Be able to provide written, informed consent themselves
- 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
- Life expectancy of less than 3 months due to terminal illness as determined by the Study Investigator
- 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
- 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
- Have a known allergy or hypersensitivity to killed whole-cell bacterial vaccines
- Any condition that, in the opinion of the Investigator, would preclude the person from participation in the study due to safety or monitoring concerns
- 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
- 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
Key Trial Info
Start Date :
April 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05421325
Start Date
April 11 2023
End Date
February 1 2026
Last Update
January 22 2025
Active Locations (1)
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1
Qu Biologics Trial Site
Burnaby, British Columbia, Canada, V5G 4X4