What this Trial Is About

Researchers are evaluating the potential of QBKPN Site-Specific Immunomodulator (SSI) to improve immune function in adults aged 65 years and older. The study focuses on whether QBKPN can help protect against respiratory and other infections, enhance the immune response to COVID-19 vaccines, improve quality of life, activity level, health status, and glycemic control. This is a Phase 2 randomized, double-blind, placebo-controlled study involving participants living in community settings, independent-living, assisted-living, and long-term care facilities. Participants will receive either QBKPN SSI or a normal saline placebo for 4 weeks. Study staff or the participants themselves will administer the treatment, with options for nurse-administration, self-administration, or a combination. After the treatment period, participants will be monitored for an additional 22 weeks. Blood and urine samples will be collected at baseline, week 4 (end of treatment), week 8, week 12, and week 26, along with a phone visit at week 20. The study will assess trained innate immunity, antiviral immune response, immune augmentation, adaptive immune response duration to SARS-CoV-2 vaccination or infection, metabolome changes, and Natural Killer cell function. During the study, participants will have regular assessments including clinical laboratory tests, safety monitoring for adverse events, and evaluations of health outcomes through medical records and patient-reported information. Researchers will track infections, hospitalizations, antibiotic or antiviral use, frailty, quality of life, end-of-life prediction scores, and all-cause mortality. The total participation duration is approximately 26 weeks with ongoing monitoring to evaluate the effects and safety of QBKPN SSI compared to placebo.

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