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

NCT05421325 | Recruiting Phase 2 DMC

• 1 other identifier: QBKPN-IS-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Immune Deficiency

Keywords

Immunosenescence; immunodegeneration; immune dysfunction; older adult

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  Baseline to Week 26

Other Outcomes (9)

• 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)

  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

  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

  Baseline to EOT (Week 4) and Weeks 8, 12 and 26

Study Arms (2)

QBKPN SSI

EXPERIMENTAL

QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks.

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.

Other: Normal Saline Placebo

Interventions

QBKPN SSI BIOLOGICAL

Site-Specific Immunomodulator

QBKPN SSI

Normal Saline Placebo OTHER

Normal Saline

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qu Biologics Inc.: lead
• The National Research Council of Canada Industrial Research Assistance Program: collaborator

Study Sites (1)

Qu Biologics Trial Site

Burnaby, British Columbia, V5G 4X4, Canada

RECRUITING

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Theodore Steiner, MD FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oksana Korolova, Director, Clinical Operations

CONTACT

236-512-3119; okorolova@qubiologics.com

Hal Gunn, MD

CONTACT

604-734-1450; hal@qubiologics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 16, 2022
• Study Start: April 11, 2023
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)