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| Name | Class |
|---|---|
| The National Research Council of Canada Industrial Research Assistance Program | UNKNOWN |
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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.
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 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.
Eligible participants will be screened and enrolled by study staff, who will conduct all study visits, and administer or teach self-administration of study treatment. Blood/sample collections will be performed by study staff or by staff at Vancouver Coastal Health Research Institute Clinical Research Unit. Participants will have the options of nurse-administration, self-administration or a combination of nurse- and self-administration of study treatment. Participants will receive study treatment for 4 weeks then be monitored for 22 weeks. Blood/urine sampling will be performed at Baseline, Weeks 4, End of Treatment, Week 8, Week 12 and Week 26. A phone call visit will be conducted at Week 20.
Immunological testing for trained innate immunity, capacity for anti-viral innate immune response, measures of immune augmentation, duration of adaptive immune response to SARS-CoV-2 vaccination and/or infection, change in metabolome and Natural Killer (NK) cell function will be performed.
Safety and tolerability of study treatment will be assessed through clinical laboratory parameters and treatment-emergent adverse events.
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)], end-of-life prediction score (CHESS Scale) and all-cause mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QBKPN SSI | Experimental | QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 4 weeks. |
|
| Placebo | Placebo Comparator | Placebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QBKPN SSI | Biological | Site-Specific Immunomodulator |
| |
| Normal Saline Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to End of Treatment (EOT) (Week 4) |
| 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. | Baseline to EOT (Week 4) and Week 8 |
| 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. | Baseline to EOT (Week 4) and Week 8 |
| 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. | Baseline to EOT (Week 4) and Week 8 |
| Change in clinical laboratory parameters (safety & tolerability) measured by urinalysis in participants treated with QBKPN SSI compared to placebo. | Urinalysis includes: blood, glucose, ketones, leukocyte esterase, nitrite, pH, protein and specific gravity. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to EOT (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oksana Korolova, Director, Clinical Operations | Contact | 236-512-3119 | okorolova@qubiologics.com | |
| Hal Gunn, MD | Contact | 604-734-1450 | hal@qubiologics.com |
| Name | Affiliation | Role |
|---|---|---|
| Theodore Steiner, MD FRCPC | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qu Biologics Trial Site | Recruiting | Burnaby | British Columbia | V5G 4X4 | Canada |
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| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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A randomized, double-blind, placebo-controlled trial
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| Other |
Normal Saline |
|
| Baseline to EOT (Week 4) and Week 8 |
| 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. | Baseline to Week 26 |
| 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 | Baseline to Week 26 |
| 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.] | Baseline to Week 26 |
| Difference in severity of all-cause respiratory tract infections assessed by PROs 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 and Pneumonia Severity Index (PORT Score) for respiratory bacterial infections. [Note: if source of infection is unknown, both WHO 8-point ordinal scale and PORT score will be collected.] | Baseline to Week 26 |
| Difference in symptom duration of all-cause respiratory tract infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo | Symptom duration assessed by medical record review | Baseline to Week 26 |
| Difference in symptom duration of all-cause respiratory tract infections assessed by PROs in participants treated with QBKPN SSI compared to placebo | Symptom duration assessed by PROs | Baseline to Week 26 |
| Number of courses of antibiotic/antiviral drugs prescribed for respiratory infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo | Number of courses of antibiotic/antiviral drugs assessed by medical record review | Baseline to Week 26 |
| Number of courses of antibiotic/antiviral drugs prescribed for respiratory infections assessed by PROs in participants treated with QBKPN SSI compared to placebo | Number of courses of antibiotic/antiviral drugs assessed by PROs | Baseline to Week 26 |
| Difference in incidence of all-cause non-respiratory infection assessed by medical record review in participants treated with QBKPN SSI compared to placebo | All-cause non-respiratory infection identified using revised McGeer Criteria and/or as determined by participants' medical providers | Baseline to Week 26 |
| Difference in incidence of all-cause non-respiratory infection assessed by PROs in participants treated with QBKPN SSI compared to placebo | All-cause non-respiratory infection identified using revised McGeer Criteria and/or as determined by participants' medical providers | Baseline to Week 26 |
| Difference in severity of all-cause non-respiratory infection assessed by medical record review in participants treated with QBKPN SSI compared to placebo | Severity of all-cause non-respiratory infection assessed by medical record review | Baseline to Week 26 |
| Difference in severity of all-cause non-respiratory infection assessed by PROs in participants treated with QBKPN SSI compared to placebo | Severity of all-cause non-respiratory infection assessed by PROs | Baseline to Week 26 |
| Difference in severity of all-cause non-respiratory infection assessed by hospitalizations due to non-respiratory infections in participants treated with QBKPN SSI compared to placebo | Severity of all-cause non-respiratory infection assessed by hospitalizations due to non-respiratory infections | Baseline to Week 26 |
| Difference in severity of all-cause non-respiratory infection assessed by mortality due to non-respiratory infections in participants treated with QBKPN SSI compared to placebo | Severity of all-cause non-respiratory infection assessed by mortality due to non-respiratory infections | Baseline to Week 26 |
| Difference in symptom duration of all-cause non-respiratory infection assessed via medical record review in participants treated with QBKPN SSI compared to placebo | Symptom duration assessed via medical record review | Baseline to Week 26 |
| Difference in symptom duration of all-cause non-respiratory infection assessed by PROs in participants treated with QBKPN SSI compared to placebo | Symptom duration assessed by PROs | Baseline to Week 26 |
| Number of courses of antibiotic/antiviral drugs prescribed for non-respiratory infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo | assessed by medical record review | Baseline to Week 26 |
| Number of courses of antibiotic/antiviral drugs prescribed for non-respiratory infections assessed by PROs in participants treated to QBKPN SSI compared to placebo | Number of courses of antibiotic/antiviral drugs assessed by PROs | Baseline to Week 26 |
| Change in quality of life as measured by Dementia Quality of Life (DEMQOL) Scale in participants treated with QBKPN SSI compared to placebo | Quality of life measured using DEMQOL Scale. Scores are from 28 to 112; higher scores indicate better quality of life | Baseline to EOT (Week 4) and Weeks 8, 12 & 26 |
| Change in frailty as measured by the Rockwood Clinical Frailty Scale in participants treated with QBKPN SSI compared to placebo | Frailty measured using Rockwood Clinical Frailty Scale. Scores are from minimum of 1 (very fit) to maximum of 7 (severely frail) | Baseline to EOT (Week 4) and Weeks 8, 12 & 26 |
| Change in end-of-life prediction score as measured by Changes in Health, End-Stage Disease and Signs and Symptoms (CHESS) scale in participants treated with QBKPN SSI compared to placebo | End-of-life prediction score measuring using CHESS scale. Scores are from minimum 0 (no health instability) to 5 (very high health instability) | Baseline to EOT (Week 4) and Weeks 8, 12 & 26 |
| Change in all-cause mortality in participants treated with QBKPN SSI compared to placebo | Recording all-cause mortality | Up to 26 weeks after first dose of study drug |
| Baseline to EOT (Week 4) and Weeks 8, 12 and 26 |
| 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 | Baseline to EOT (Week 4) and Weeks 8, 12 and 26 |
| 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 | Baseline to EOT (Week 4) and Weeks 8, 12 and 26 |
| 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 | Baseline to EOT (Week 4) and Weeks 8, 12 and 26 |
| Change in plasma metabolome measured using mass spectrometry (untargeted) to assess which metabolites are significantly changed by treatment and which may predict response to treatment in patients treated with QBKPN SSI compared to placebo. | Change in plasma metabolome measured using untargeted mass spectrometry | Baseline to EOT (Week 4) and Weeks 8, 12 and 26 |
| Assessment of correlation of Immunoglobulin G (IgG) antibodies to K.variicola with the NK cell function and innate immune training in participants treated with QBKPN SSI compared to placebo | Correlation assessed by quantification of IgG antibodies to K. variicola and correlation with NK Vue assay and RBM Myriad's TLR4 ligand (LPS) TruCulture Tube assay results | Baseline to EOT (Week 4) and Week 26 |
| Evaluation of durability of QBKPN SSI beyond EOT in participants treated with QBKPN SSI compared to placebo | Durability of QBKPN SSI assessed by measuring innate immune training (see Outcome #1), anti-viral innate immunity (see Outcome #6), circulating Natural Killer (NK) cell function (see Outcome #37), all-cause respiratory and non-respiratory infections (see Outcomes #7 to #24) | Up to 26 weeks after first dose of study drug |
| Assessment of glycemic control through hemoglobin A1C (HbA1c) in participants treated with QBKPN compared to placebo | Change in HbA1c | Baseline to EOT (Week 4) and Weeks 8, 12 & 26. |
| Assessment of NK cell function in participants treated with QBKPN SSI compared to placebo | NK cell function assessed by measuring stimulated IFN-y production using the NK Vue assay | Baseline to EOT (Week 4) |