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

Launched by QU BIOLOGICS INC. · Jun 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called QBKPN, which is designed to help improve the immune system of older adults. The main goal is to see if QBKPN can help protect against respiratory infections, improve responses to COVID-19 vaccines, and enhance overall quality of life for people aged 65 and older. Researchers are particularly interested in how this medication can support the body's natural defenses and help manage blood sugar levels.

To participate in the trial, individuals must be 65 years or older, live in the community or in a long-term care facility, and be able to provide consent for themselves. Participants will take the medication for four weeks and will be monitored for any changes in their health, activity levels, and immune function. It's important to note that certain people, such as those with specific health conditions or currently undergoing treatments for infections or cancer, may not be eligible to join the study.

Gender

ALL

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