Assessment of QBKPN SSI Efficacy in Improving Innate Immune Function in Older Adults (RESILIENCE)
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 of Older Residing in Independent-Living, Assisted-Living and Long-term Care Facilities
This is a randomized, double-blind, placebo-controlled study of adults 65 years of age or older residing in the community, in long-term care (LTC), independent-living or assisted-living facilities to assess the effect of QBKPN SSI on improvement of innate immunity and reduction of all-cause respiratory tract infection morbidity.
Approximately 72 participants will be enrolled; approximately 36 from the community and independent-living facilities and approximately 36 from assisted-living and LTC facilities.
Participants will receive study treatment for 16 weeks then be monitored for 36 weeks post-study treatment with follow-up study visits and blood sampling performed.
Immunological testing for trained innate immunity, Natural Killer (NK) cell function, and anti-viral innate immunity will be performed.
Clinical benefits of study treatment will be assessed via medical record review and patient-reported outcomes. Study staff will record any confirmed/probable/possible infections (viral and bacterial, including respiratory and non-respiratory), any microbiologic or radiologic testing performed to investigate for infection, any prescribed antibiotics/antivirals and duration of treatment and reason for and duration of any hospitalizations.
Clinical assessments will also include frailty index (Rockwood Clinical Frailty Scale), quality of life [Dementia Quality of Life Questionnaire(DEMQOL)] and end-of-life prediction score (CHESS Scale.)
- QBKPN SSI
- Normal Saline Placebo
- Demonstrate innate immune training
- Change in Natural Killer (NK) cell function measured by stimulated Interferon Gamma (IFN-y) production using the NK Vue® assay
- Incidence of treatment-emergent adverse events (safety & tolerability) in participants treated with QBKPN SSI compared to placebo
- Evaluate capacity for anti-viral innate immune response
- Difference in incidence of all-cause respiratory tract infections
- Difference in symptom duration of all-cause respiratory tract infections
- Number of courses of antibiotic/antiviral drugs prescribed
- Difference in incidence of all-cause non-respiratory infection
- Change in quality of life as measured by Dementia Quality of Life (DEMQOL) Scale
- Change in frailty as measured by the Rockwood Clinical Frailty Scale
- Change in end-of-life prediction score as measured by Changes in Health, End-Stage Disease and Signs and Symptoms (CHESS) scale
- Change in all-cause mortality
- Change in additional measures of plasma immune biomarkers that regulate innate & adaptive immune function augmentation
Qu Biologics Inc.
Additional Funding Provided By
- The National Research Council of Canada Industrial Research Assistance Program
- Principal Investigator: Theodore Steiner, MD FRCPC, University of British Columbia
Posted on ClinicalTrials.gov