At least one million people in the United States were hospitalized last year due to respiratory viruses such as influenza and COVID-19, according to data from the Centers for Disease Control and Prevention. Many of these cases involved individuals at higher risk because of their proximity to young children, who frequently contract respiratory infections.
Researchers at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health (CVD) have initiated a new clinical trial aimed at testing an experimental intranasal spray designed to enhance immune defenses against respiratory viruses. The study is being conducted in partnership with ENA Respiratory, which manufactures the therapy.
The randomized, double-blind Phase 2 trial plans to enroll 1,100 healthy adults between the ages of 18 and 45. These participants are considered at increased risk for upper respiratory virus infections due to regular exposure to young children or frequent close contact with others. Study subjects will be randomly assigned either the investigational intranasal spray, called INNA-051, or a placebo spray. The goal is to determine if INNA-051 is safe and more effective than a placebo in boosting immune response and preventing illness.
"This study represents a new approach to reducing illness from respiratory infections," said Justin Ortiz, MD, Professor of Medicine and UMSOM Principal Investigator for the ongoing trial. "Instead of targeting a single virus, INNA-051 strengthens the body's early immune defenses, which may help mitigate disease caused by multiple respiratory pathogens."
INNA-051 is not a vaccine but rather a prophylactic drug intended for weekly use during cold and flu season. It functions as a TLR2/6 agonist by priming the immune system’s initial defense mechanisms. This process aims to accelerate removal of harmful germs from nasal passages before they can establish infection in the body. Because it is virus-agnostic, INNA-051 could potentially offer protection against various viruses that replicate initially in nasal passages, including those responsible for colds, flu, and COVID-19. The trial will examine whether use of INNA-051 reduces either severity or likelihood of illness during respiratory virus season.
"This trial exemplifies CVD's commitment to conducting innovative clinical research aimed at reducing the burden of infectious disease. INNA-051 has the potential to protect those most vulnerable to respiratory viral complications, including persons with chronic lung disease, heart disease, and diabetes," said James Campbell, MD, MS, Professor of Pediatrics at UMSOM and Interim Director of CVD.
UMSOM Dean Mark T. Gladwin, MD stated: "Our researchers are aiming to demonstrate the exciting potential of TLR2/6 agonists to become the first prophylactic therapy against respiratory viral illness. Respiratory viruses continue to challenge our healthcare systems because they evade our body's most fundamental immune barrier—the mucosal surfaces of our airways. A preventive approach that strengthens this frontline of defense has the potential to transform how we reduce viral transmission in the community and could help build resilience against future respiratory threats."
More information about this study and other CVD clinical trials can be found at CVDTrials.org.
