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RECRUITING

NCT05421325

PHASE2

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

Sponsor: Qu Biologics Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-04-11

Completion Date

2026-02

Last Updated

2025-01-22

Healthy Volunteers

Conditions

Immune Deficiency

Interventions

BIOLOGICAL

QBKPN SSI

Site-Specific Immunomodulator

OTHER

Normal Saline Placebo

Normal Saline

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