Immune DeficiencyPhase 2RESILIENCENCT05421325
Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults
A Phase 2 study testing QBKPN SSI in people with Immune Deficiency, run by Qu Biologics Inc. at 1 site in Canada.
Trial 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, what effect it has on maintaining or improving quality of life, activity level and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Immune Deficiency
- What is being tested?
- QBKPN SSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2023to Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Qu Biologics Trial Site
Burnaby, British Columbia, V5G 4X4
Nimmy George, BSc, 672-963-7872, ngeorge@qubiologics.com
Theodore Steiner, MD FRCPC
About this study
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 or Older Residing in the Community, in Independent-Living, Assisted-Living and Long-term Care Facilities
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.
Read the detailed description
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.
- Conditions
- Immune Deficiency
- Being tested
- QBKPN SSI, Normal Saline Placebo
- Keywords
- Immunosenescence, immunodegeneration, immune dysfunction, older adult
- Medical subject headings
- Immunologic Deficiency Syndromes, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBKPN SSIBiological
Site-Specific Immunomodulator
Normal Saline PlaceboOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| QBKPN SSI | Experimental | QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks. Receives: Biological: QBKPN SSI |
| Placebo | Placebo comparator | Placebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks. Receives: Other: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to EOT (Week 4) and Week 8
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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
Measured: 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.]
Measured: 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.]
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Up to 26 weeks after first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start11 Apr 2023
- Primary completionSep 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qu Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The National Research Council of Canada Industrial Research Assistance Program
- Responsible party
- Sponsor
- Investigators
- Theodore Steiner, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421325
- Sponsor's protocol ID
- QBKPN-IS-01
- Acronym
- RESILIENCE
- Status last verified
- Jan 2025
- First submitted
- 11 May 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 or Older Residing in the Community, in Independent-Living, Assisted-Living and Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT05421325
- Acronym / sponsor ID
- RESILIENCE / QBKPN-IS-01
- Conditions
- Immune Deficiency
- Keywords
- Immunosenescence, immunodegeneration, immune dysfunction, older adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Qu Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- The National Research Council of Canada Industrial Research Assistance Program
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| QBKPN SSI | Experimental | Biological: QBKPN SSIQBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks. |
| Placebo | Placebo comparator | Other: Normal Saline PlaceboPlacebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QBKPN SSISite-Specific Immunomodulator | Biological | QBKPN SSI |
| Normal Saline PlaceboNormal Saline | Other | Placebo |
Primary outcome
Evaluate innate immune training in participants treated with QBKPN SSI compared to placebo.
Time frame: Baseline to End of Treatment (EOT) (Week 4)
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.
Time frame: Baseline to EOT (Week 4) and Week 8
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.
Time frame: Baseline to EOT (Week 4) and Week 8
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.
Time frame: Baseline to EOT (Week 4) and Week 8
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 with QBKPN SSI compared to placebo.
Time frame: Baseline to EOT (Week 4) and Week 8
Urinalysis includes: blood, glucose, ketones, leukocyte esterase, nitrite, pH, protein and specific gravity.
23 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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Up to 26 weeks after first dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theodore Steiner, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QBKPN SSI in people with Immune Deficiency, run by Qu Biologics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oksana Korolova, Director, Clinical Operations (236-512-3119, okorolova@qubiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate innate immune training in participants treated with QBKPN SSI compared to placebo. (time frame: Baseline to End of Treatment (EOT) (Week 4)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.