Study to Test QBKPN Immunomodulator for Boosting Immune Function and Lowering Respiratory Infections in Adults 65 and Older Living in Community or Care Facilities

What this Trial Is About

Researchers are evaluating the effects of QBKPN, a new type of Site-Specific Immunomodulator SSI, on immune function in adults aged 65 and older. This study aims to see if QBKPN can improve the bodys innate immune response, reduce respiratory and other infections, enhance response to COVID-19 vaccines, and support quality of life, activity level, health status, and blood sugar control. The trial involves participants from various living settings including community, independent living, assisted living, and long-term care facilities. Participants will be randomly assigned to receive either QBKPN SSI or a placebo, both given as 0.1 mL subcutaneous injections three times a week Monday, Wednesday, and Friday for four weeks. Treatment can be administered by a nurse, self-injected, or a combination of both. After the four-week treatment period, participants will be monitored for 22 more weeks. Blood and urine samples will be collected at multiple points including baseline, weeks 4, 8, 12, and 26, with an additional phone check at week 20. During the study, researchers will perform various tests to assess immune training, antiviral response, immune cell function, and metabolic changes. Safety will be monitored through lab tests and tracking any side effects. Researchers will also review medical records and participant reports to record infections, treatments, hospitalizations, frailty, quality of life, and survival. The total participation lasts about 26 weeks from the first dose.

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