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

NCT ID: NCT05421325

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2026-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

QBKPN SSI

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

Group Type: EXPERIMENTAL

QBKPN SSI

Intervention Type: BIOLOGICAL

Site-Specific Immunomodulator

Placebo

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

Group Type: PLACEBO_COMPARATOR

Normal Saline Placebo

Intervention Type: OTHER

Normal Saline

Interventions

QBKPN SSI

Site-Specific Immunomodulator

Intervention Type: BIOLOGICAL

Normal Saline Placebo

Normal Saline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The National Research Council of Canada Industrial Research Assistance Program

UNKNOWN

Sponsor Role: collaborator

Qu Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Steiner, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Qu Biologics Trial Site

Burnaby, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Oksana Korolova, Director, Clinical Operations

Role: CONTACT

okorolova@qubiologics.com

236-512-3119

Hal Gunn, MD

Role: CONTACT

hal@qubiologics.com

604-734-1450

Facility Contacts

Nimmy George, BSc

Role: primary

ngeorge@qubiologics.com

672-963-7872

Other Identifiers

QBKPN-IS-01

Identifier Type: -

Identifier Source: org_study_id