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

Phase

Condition

Hiv Infections

Transplant Rejection

Respiratory Syncytial Virus (Rsv) Infection

Treatment

QBKPN SSI

Normal Saline Placebo

Clinical Study ID

NCT05421325

QBKPN-IS-01

Ages > 65
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Be a resident of the community or a long-term care, independent-living or assistedliving 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 potentialmust be surgically sterile or agree to practice effective barrier contraceptionduring the entire study treatment period (4 weeks) and one month after the last doseof study drug or agree to completely abstain from vaginal intercourse with women ofchildbearing potential during this period.

Exclusion

Exclusion Criteria:

Life expectancy of less than 3 months due to terminal illness as determined by theStudy 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 systemicimmunosuppressants. Note: NSAIDs, colchicine, aspirin and oral glucocorticoids at adose 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 orprobable 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 personfrom participation in the study due to safety or monitoring concerns
Any treatment with experimental or investigational therapies within 3 months priorto Screening and/or any planned treatment with experimental or investigationaltherapies during the entire course of study participation
On current treatment for active malignancies (e.g., chemotherapy, radiation) orplanned cancer surgery during the study period. Note: People on exclusively hormonaltherapy for breast or prostate cancer are allowed. People with prior or plannedsurgery for localized squamous cell or basal cell carcinoma of the skin are allowed

Study Design

QBKPN SSI

April 11, 2023

February 28, 2026

Study 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.

Connect with a study center

Qu Biologics Trial Site
Burnaby, British Columbia V5G 4X4
Canada
Active - Recruiting

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