Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults

Phase 2RecruitingNCT05421325

Qu Biologics Inc.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Interventions

QBKPN SSIBIOLOGICAL

Site-Specific Immunomodulator

Normal Saline PlaceboOTHER

Normal Saline

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be a resident of the community or a long-term care, independent-living or assisted living facility participating in the study 2. Be aged 65 years or older 3. Be able to provide written, informed consent themselves 4. 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 Criteria: 1. Life expectancy of less than 3 months due to terminal illness as determined by the Study Investigator 2. 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 3. 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 4. Have a known allergy or hypersensitivity to killed whole-cell bacterial vaccines 5. Any condition that, in the opinion of the Investigator, would preclude the person from participation in the study due to safety or monitoring concerns 6. 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 7. 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

Locations (1)

Qu Biologics Trial Site

Burnaby, British Columbia, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to EOT (Week 4) and Week 8

Secondary Outcomes

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.

Time frame: Baseline to EOT (Week 4)

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.

Time frame: 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

Time frame: 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. \[Note: if source of infection is unknown, both WHO 8-point ordinal scale and PORT score will be collected.\]

Time frame: 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. \[Note: if source of infection is unknown, both WHO 8-point ordinal scale and PORT score will be collected.\]

Central Contacts

Oksana Korolova, Director, Clinical Operations

CONTACT

236-512-3119 okorolova@qubiologics.com

Hal Gunn, MD

CONTACT

604-734-1450 hal@qubiologics.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: Up to 26 weeks after first dose of study drug

Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts