Actively Recruiting
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
Led by Qu Biologics Inc. · Updated on 2025-01-22
72
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
Q
Qu Biologics Inc.
Lead Sponsor
T
The National Research Council of Canada Industrial Research Assistance Program
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of QBKPN, a new type of Site-Specific Immunomodulator (SSI), on immune function in adults aged 65 and older. This study aims to see if QBKPN can improve the body's innate immune response, reduce respiratory and other infections, enhance response to COVID-19 vaccines, and support quality of life, activity level, health status, and blood sugar control. The trial involves participants from various living settings including community, independent living, assisted living, and long-term care facilities. Participants will be randomly assigned to receive either QBKPN SSI or a placebo, both given as 0.1 mL subcutaneous injections three times a week (Monday, Wednesday, and Friday) for four weeks. Treatment can be administered by a nurse, self-injected, or a combination of both. After the four-week treatment period, participants will be monitored for 22 more weeks. Blood and urine samples will be collected at multiple points including baseline, weeks 4, 8, 12, and 26, with an additional phone check at week 20. During the study, researchers will perform various tests to assess immune training, antiviral response, immune cell function, and metabolic changes. Safety will be monitored through lab tests and tracking any side effects. Researchers will also review medical records and participant reports to record infections, treatments, hospitalizations, frailty, quality of life, and survival. The total participation lasts about 26 weeks from the first dose.
CONDITIONS
Brief Title
Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 use effective barrier contraception during the study treatment period and one month after last dose or abstain from vaginal intercourse during this period
You will not qualify if you...
- Life expectancy of less than 3 months due to terminal illness as determined by the Study Investigator
- Taking biologic immunosuppressive agents or other systemic immunosuppressants (some exceptions allowed)
- Currently being treated or treated within 30 days with systemic antibiotics or antivirals for infection
- Known allergy or hypersensitivity to killed whole-cell bacterial vaccines
- Any condition that would preclude participation due to safety or monitoring concerns
- Treatment with experimental therapies within 3 months prior to screening or planned during study
- On current treatment for active malignancies or planned cancer surgery during study period (some exceptions allowed)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive QBKPN SSI or placebo by subcutaneous injection three times per week (Monday, Wednesday, and Friday) for 4 weeks. Study staff administer or teach self-administration of the treatment. Blood and urine samples are collected at baseline and end of treatment to assess immune function and safety.
Approximately 12 injection visits and blood/urine sample collections at baseline and Week 4
Duration - 22 weeks
Participants are monitored for 22 weeks after treatment to assess immune response durability, incidence and severity of respiratory and non-respiratory infections, safety, quality of life, frailty, and mortality. Blood and urine samples are collected at Weeks 8, 12, and 26. A phone call visit is conducted at Week 20.
Blood/urine sample collections at Weeks 8, 12, and 26 plus 1 phone call visit at Week 20
Trial Site Locations
Total: 1 location
1
Qu Biologics Trial Site
Burnaby, British Columbia, Canada, V5G 4X4
Actively Recruiting
Research Team
O
Oksana Korolova, Director, Clinical Operations
H
Hal Gunn, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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