Back to resultsAssessment of QBKPN Site-Specific Immunomodulator Efficacy in Improving Innate Immune Function & Reducing Respiratory Tract Infection Morbidity in Older Adults (RESILIENCE)
Primary Purpose
Immune Deficiency
Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
QBKPN SSI
Normal Saline Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Immune Deficiency focused on measuring Immunosenescence, immunodegeneration, immune dysfunction, older adult
Eligibility Criteria
Inclusion Criteria:
- Be a resident of 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 period and one month after the last dose of study drug or agree to completely abstain from vaginal intercourse with women of childbearing potential during their participation in the study
Exclusion Criteria:
- Life expectancy of less than 3 months due to terminal illness as determined by the Principal or Sub-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 antibiotics/antivirals
- Have a known allergy or hypersensitivity to killed whole-cell bacterial vaccines
- Any condition that, in the opinion of the Investigator, would preclude the person from participation in the study due to safety or monitoring concerns
- 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
- 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
Sites / Locations
- Qu Biologics Trial Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
QBKPN SSI
Placebo
Arm Description
QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 16 weeks
Placebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 16 weeks
Outcomes
Primary Outcome Measures
Change in Natural Killer (NK) cell function measured by stimulated Interferon Gamma (IFN-y) production using the NK Vue® assay (https://www.nkmax.com/eng/bbs/content.php?co_id=nkvuekit) in patients treated with QBKPN SSI compared to placebo
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
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
Change in clinical laboratory parameters (safety & tolerability) measured by urinalysis in participants treated wtih QBKPN SSI compared to placebo
Urinalysis includes: blood, glucose, ketones, leukocyte esterase, nitrite, pH and specific gravity
Secondary Outcome Measures
Demonstrate innate immune training by measuring change in stimulated Interleukin-1 beta (IL-1B) and Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) in participants treated with QBKPN SSI compared to placebo
IL-1B and GM-CSF measured using RBM Myriad's Toll-like Receptor 4 (TLR4) ligand Lipopolysaccharide (LPS) TruCulture Tube Assay
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 (TLR7/8) agonist (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.]
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.]
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of courses of antibiotic/antiviral drugs prescribed for non-respiratory infections assessed by PROs
Number of courses of antibiotic/antiviral drugs assessed by PROs
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
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)
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)
Change in all-cause mortality in participants treated with QBKPN SSI compared to placebo
Full Information
NCT ID
NCT05421325
First Posted
May 11, 2022
Last Updated
August 16, 2023
Sponsor
Qu Biologics Inc.
Collaborators
The National Research Council of Canada Industrial Research Assistance Program
1. Study Identification
Unique Protocol Identification Number
NCT05421325
Brief Title
Assessment of QBKPN Site-Specific Immunomodulator Efficacy in Improving Innate Immune Function & Reducing Respiratory Tract Infection Morbidity in Older Adults
Acronym
RESILIENCE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qu Biologics Inc.
Collaborators
The National Research Council of Canada Industrial Research Assistance Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 and what effect it has on maintaining or improving quality of life, activity level and health status.
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.
Detailed Description
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.
Eligible participants will be screened and enrolled in the study by visiting study staff, who will conduct all study visits, administer study treatment and perform blood/sample collections. 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 Natural Killer (NK) cell function, anti-viral innate immunity and trained innate immunity will be performed.
Safety and tolerability of study treatment will be measured with change in clinical laboratory parameters.
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Deficiency
Keywords
Immunosenescence, immunodegeneration, immune dysfunction, older adult
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QBKPN SSI
Arm Type
Experimental
Arm Description
QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 16 weeks
Intervention Type
Biological
Intervention Name(s)
QBKPN SSI
Intervention Description
Site-Specific Immunomodulator
Intervention Type
Other
Intervention Name(s)
Normal Saline Placebo
Intervention Description
Normal Saline
Primary Outcome Measure Information:
Title
Change in Natural Killer (NK) cell function measured by stimulated Interferon Gamma (IFN-y) production using the NK Vue® assay (https://www.nkmax.com/eng/bbs/content.php?co_id=nkvuekit) in patients treated with QBKPN SSI compared to placebo
Description
NK cell function measured by stimulated Interferon Gamma (IFN-y) production using the NK Vue assay
Time Frame
Baseline to Week 16
Title
Incidence of treatment-emergent adverse events (safety & tolerability) in participants treated with QBKPN SSI compared to placebo
Description
Treatment-emergent adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
Baseline to Week 26
Title
Change in clinical laboratory parameters (safety & tolerability) measured by blood hematology analysis in participants treated with QBKPN SSI compared to placebo
Description
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 Week 26
Title
Change in clinical laboratory parameters (safety & tolerability) measured by blood chemistry analysis in participants treated with QBKPN SSI compared to placebo
Description
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 Week 26
Title
Change in clinical laboratory parameters (safety & tolerability) measured by urinalysis in participants treated wtih QBKPN SSI compared to placebo
Description
Urinalysis includes: blood, glucose, ketones, leukocyte esterase, nitrite, pH and specific gravity
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Demonstrate innate immune training by measuring change in stimulated Interleukin-1 beta (IL-1B) and Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) in participants treated with QBKPN SSI compared to placebo
Description
IL-1B and GM-CSF measured using RBM Myriad's Toll-like Receptor 4 (TLR4) ligand Lipopolysaccharide (LPS) TruCulture Tube Assay
Time Frame
Baseline to Week 16
Title
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
Description
Type I and type III interferon production measured using RBM Myriad's Toll-like Receptor 7/8 (TLR7/8) agonist (Resiquimod R848) TruCulture Tube assay
Time Frame
Baseline to Week 16
Title
Difference in incidence of all-cause respiratory tract infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo
Description
Respiratory tract infections identified using revised McGeer Criteria and/or as determined by participants' medical providers
Time Frame
Baseline to Week 16
Title
Difference in incidence of all-cause respiratory tract infections assessed by patient reported outcomes (PROs) in participants treated with QBKPN SSI compared to placebo
Description
Respiratory tract infections identified using revised McGeer Criteria and/or as determined by participants' medical providers
Time Frame
Baseline to Week 16
Title
Difference in severity of all-cause respiratory tract infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo
Description
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 16
Title
Difference in severity of all-cause respiratory tract infections assessed by PROs in participants treated with QBKPN SSI compared to placebo
Description
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.]
Time Frame
Baseline to Week 16
Title
Difference in symptom duration of all-cause respiratory tract infections assessed by medical record review in participants treated with QBKPN SSI compared to placebo
Description
Symptom duration assessed by medical record review
Time Frame
Baseline to Week 16
Title
Difference in symptom duration of all-cause respiratory tract infections assessed by PROs in participants treated with QBKPN SSI compared to placebo
Description
Symptom duration assessed by PROs
Time Frame
Baseline to Week 16
Title
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
Description
Number of courses of antibiotic/antiviral drugs assessed by medical record review
Time Frame
up to 52 weeks after first dose of study drug
Title
Number of courses of antibiotic/antiviral drugs prescribed for respiratory infections assessed by PROs in participants treated with QBKPN SSI compared to placebo
Description
Number of courses of antibiotic/antiviral drugs assessed by PROs
Time Frame
up to 52 weeks after first dose of study drug
Title
Difference in incidence of all-cause non-respiratory infection assessed by medical record review in participants treated with QBKPN SSI compared to placebo
Description
All-cause non-respiratory infection identified using revised McGeer Criteria and/or as determined by participants' medical providers
Time Frame
Baseline to Week 16
Title
Difference in incidence of all-cause non-respiratory infection assessed by PROs in participants treated with QBKPN SSI compared to placebo
Description
All-cause non-respiratory infection identified using revised McGeer Criteria and/or as determined by participants' medical providers
Time Frame
Baseline to Week 16
Title
Difference in severity of all-cause non-respiratory infection assessed by medical record review in participants treated with QBKPN SSI compared to placebo
Description
Severity of all-cause non-respiratory infection assessed by medical record review
Time Frame
Baseline to Week 16
Title
Difference in severity of all-cause non-respiratory infection assessed by PROs in participants treated with QBKPN SSI compared to placebo
Description
Severity of all-cause non-respiratory infection assessed by PROs
Time Frame
Baseline to Week 16
Title
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
Description
Severity of all-cause non-respiratory infection assessed by hospitalizations due to non-respiratory infections
Time Frame
Baseline to Week 16
Title
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
Description
Severity of all-cause non-respiratory infection assessed by mortality due to non-respiratory infections
Time Frame
Baseline to Week 16
Title
Difference in symptom duration of all-cause non-respiratory infection assessed via medical record review in participants treated with QBKPN SSI compared to placebo
Description
Symptom duration assessed via medical record review
Time Frame
Baseline to Week 16
Title
Difference in symptom duration of all-cause non-respiratory infection assessed by PROs in participants treated with QBKPN SSI compared to placebo
Description
Symptom duration assessed by PROs
Time Frame
Baseline to Week 16
Title
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
Description
assessed by medical record review
Time Frame
up to 52 weeks after first dose of study drug
Title
Number of courses of antibiotic/antiviral drugs prescribed for non-respiratory infections assessed by PROs
Description
Number of courses of antibiotic/antiviral drugs assessed by PROs
Time Frame
up to 52 weeks after first dose of study drug
Title
Change in quality of life as measured by Dementia Quality of Life (DEMQOL) Scale in participants treated with QBKPN SSI compared to placebo
Description
Quality of life measured using DEMQOL Scale. Scores are from 28 to 112; higher scores indicate better quality of life
Time Frame
Baseline to Weeks 16, 34 & 52
Title
Change in frailty as measured by the Rockwood Clinical Frailty Scale in participants treated with QBKPN SSI compared to placebo
Description
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 Weeks 16, 34 & 52
Title
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
Description
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 Weeks 16, 34 & 52
Title
Change in all-cause mortality in participants treated with QBKPN SSI compared to placebo
Time Frame
Up to 52 weeks after first dose of study drug
Other Pre-specified Outcome Measures:
Title
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)
Description
Plasma immune biomarkers measured using TruCulture Tube assay (under stimulated and unstimulated conditions) of 48 analytes (cytokines & chemokines) using multiplex technology assessment
Time Frame
Baseline to Weeks 8,16, 26, 34, 42 & 52
Title
Evaluation of duration of adaptive immune response to SARS-CoV-2 vaccination 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
Description
Adaptive immune response measured by CD4+ and CD8+ T-cell response to SARS-CoV-2 S protein-derived peptides
Time Frame
Baseline to Weeks 16, 34 & 52
Title
Evaluation of duration of adaptive immune response to SARS-CoV-2 vaccination measured by change in SARS-CoV-2 anti-S antibody titer in participants treated with QBKPN SSI compared to placebo
Description
Adaptive immune response to SARS-CoV-2 vaccination measured by SARS-CoV-2 anti-S antibody titer
Time Frame
Baseline to Weeks 16, 34 & 52
Title
Evaluation of duration of adaptive immune response to SARS-CoV-2 vaccination measured by change in SARS-CoV-2 anti-S antibody secretion from antigen stimulated Peripheral Blood Mononuclear Cells (PBMCs)
Description
Adaptive immune response to SARS-CoV-2 vaccination measured by SARS-CoV-2 anti-S antibody secretion from antigen stimulated Peripheral Blood Mononuclear Cells (PBMCs) in participants treated with QBKPN versus placebo
Time Frame
Baseline to Weeks 16, 34 & 52
Title
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.
Description
Change in plasma metabolome measured using untargeted mass spectrometry
Time Frame
Baseline to Weeks 16, 34 & 52
Title
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
Description
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
Time Frame
Baseline to Weeks 16 & 52
Title
Evaluation of durability of QBKPN SSI beyond Week 16 in participants treated with QBKPN SSI compared to placebo
Description
Durability of QBKPN SSI assessed by measuring NK cell function (see Outcome #1), innate immune training (see Outcome #4), anti-viral innate immunity (see Outcome #5), all-cause respiratory and non-respiratory infections (see Outcomes #6 to #11)
Time Frame
Up to 52 weeks after first dose of study drug
Title
Assessment of glycemic control through hemoglobin A1C (HbA1c) in participants treated with QBKPN compared to placebo
Description
Change in HbA1c
Time Frame
Baseline to Weeks 16 & 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 (16 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:
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
Any condition that, in the opinion of the Investigator, would preclude the person from participation in the study due to safety or monitoring concerns
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Steiner, MD FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qu Biologics Trial Site
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 4X4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of QBKPN Site-Specific Immunomodulator Efficacy in Improving Innate Immune Function & Reducing Respiratory Tract Infection Morbidity in Older Adults
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