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 response to COVID-19 vaccines, what effect it has on maintaining or improving quality of life, activity level and health status and whether it has an effect on glycemic control.
QBKPN is a new medication in a class known as Site-Specific Immunomodulators (SSI). SSIs are designed to train and/or improve innate immune function to reduce the risk of infections, improve immune response to cancer, and slow the progression of chronic inflammatory diseases.
It is believed that QBKPN SSI can work with the immune system to help protect against respiratory and other infections.
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.
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
Parallel
QBKPN SSI
Biological/VaccineSite-Specific Immunomodulator
Normal Saline Placebo
Other interventionNormal Saline
Evaluate innate immune training in participants treated with QBKPN SSI compared to placebo.
Innate immune training will be measured by change in stimulated IL-β using RBM Myriad's TLR4 ligand (LPS) TruCulture Tube assay.
Incidence of treatment-emergent adverse events (safety & tolerability) in participants treated with QBKPN SSI compared to placebo.
Treatment-emergent adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Change in clinical laboratory parameters (safety & tolerability) measured by blood hematology analysis in participants treated with QBKPN SSI compared to placebo.
Hematology analysis includes: Hematocrit (Hct), Hemoglobin (Hgb), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV), platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential.
Change in clinical laboratory parameters (safety & tolerability) measured by blood chemistry analysis in participants treated with QBKPN SSI compared to placebo.
Clinical chemistry analysis includes: Alanine Aminotransferase (ALT), Albumin (ALB), Alkaline Phosphatase (ALK-P), Aspartate Aminotransferase (AST), bilirubin, Gamma-Glutamyl Transferase (GGT), creatinine, estimated Glomerular Filtration Rate (eGFR), C-Reactive Protein (CRP), electrolytes.
Evaluate capacity for anti-viral innate immune response by measuring change in stimulated type I and type III interferon production in participants treated with QBKPN SSI compared to placebo.
Type I and type III interferon production measured using RBM Myriad's Toll-like Receptor 7/8 agonist (TLR7/8) (Resiquimod R848) TruCulture Tube assay.
Difference in incidence of all-cause respiratory tract infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo.
Respiratory tract infections identified using revised McGeer Criteria and/or as determined by participants' medical providers.
Difference in incidence of all-cause respiratory tract infections assessed by patient reported outcomes (PROs) in participants treated with QBKPN SSI compared to placebo.
Respiratory tract infections identified using revised McGeer Criteria and/or as determined by participants' medical providers
Difference in severity of all-cause respiratory tract infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo.
Severity of all-cause respiratory tract infections measured using World Health Organization (WHO) 8-point ordinal scale for respiratory viral infections \[minimum score 0 (uninfected) to maximum score 8 (death)\] and Pneumonia Severity Index (PORT Score) (minimum: Class I, 0.1% mortality to maximum: Class V, 27% mortality) for respiratory bacterial infections. \[Note: if source of infection is unknown, both WHO 8-point ordinal scale and PORT score will be collected.\]
Change in additional measures of plasma immune biomarkers that regulate innate & adaptive immune function augmentation measured using TruCulture Tube® assay (under stimulated & unstimulated conditions) of 48 analytes (cytokines & chemokines)
Plasma immune biomarkers measured using TruCulture Tube assay (under stimulated and unstimulated conditions) of 48 analytes (cytokines \& chemokines) using multiplex technology assessment
Evaluation of duration of adaptive immune response to SARS-CoV-2 vaccination and/or infection measured by change in Cluster of Differentiation 4+ (CD4+) and Cluster of Differentiation 8+ (CD8+) T-cell response to SARS-CoV-2 S protein-derived peptides
Adaptive immune response measured by CD4+ and CD8+ T-cell response to SARS-CoV-2 S protein-derived peptides
Evaluation of duration of adaptive immune response to SARS-CoV-2 vaccination and/or infection measured by change in SARS-CoV-2 anti-S antibody titer in participants treated with QBKPN SSI compared to placebo
Adaptive immune response to SARS-CoV-2 vaccination and/or infection measured by SARS-CoV-2 anti-S antibody titer
Evaluation of duration of adaptive immune response to SARS-CoV-2 vaccination and/or infection measured by change in SARS-CoV-2 anti-S antibody secretion from antigen stimulated Peripheral Blood Mononuclear Cells (PBMCs)
Adaptive immune response to SARS-CoV-2 vaccination and/or infection measured by SARS-CoV-2 anti-S antibody secretion from antigen stimulated Peripheral Blood Mononuclear Cells (PBMCs) in participants treated with QBKPN versus placebo
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Qu Biologics Inc.
Lead sponsor
The National Research Council of Canada Industrial Research Assistance Program
Collaborator
