At least one million people in the U.S. were hospitalized last year due to common respiratory viruses like the flu or COVID-19, according to the Centers for Disease Control and Prevention. That staggering number highlights a critical vulnerability: those who live or work near young children, who tend to contract—and spread—more respiratory infections. Now, a new clinical trial is underway, testing an experimental nasal spray that aims to bolster immune defenses and reduce illness from these pervasive viruses.
A New Approach to Fighting Respiratory Viruses
Researchers are exploring a preventative nasal spray to strengthen the body’s natural defenses against a range of respiratory illnesses.
- The Phase 2 trial will enroll 1,100 healthy adults aged 18 to 45.
- Participants are those at increased risk of infection due to exposure to young children or frequent close contact.
- The spray, called INNA-051, is designed to be used weekly during respiratory virus season.
- It works by priming the immune system’s first line of defense, potentially protecting against multiple viruses.
The randomized, double-blind trial, led by researchers at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health, is being conducted in collaboration with ENA Respiratory, the therapy’s manufacturer. Participants will receive either the investigational intranasal spray, INNA-051, or a placebo to determine its safety and effectiveness in boosting the 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 a respiratory illness specialist who is the 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 isn’t a vaccine. Instead, this prophylactic drug is designed for weekly use during cold and flu season. It’s a TLR2/6 agonist, meaning it works by activating the immune system’s initial defenses to clear harmful germs from the nasal passages before they can establish an infection. The spray is “virus-agnostic,” potentially offering protection against a broad spectrum of viruses, including influenza, common colds, and COVID-19, as it targets the nasal passages—where these viruses initially replicate.
James Campbell, MD, MS, Professor of Pediatrics and Interim Director of the Center for Vaccine Development and Global Health, emphasized the trial’s broader implications. “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.”
Mark T. Gladwin, MD, Dean of the University of Maryland School of Medicine, added, “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.”
Those interested in learning more about this and other clinical trials can visit CVDTrials.org.
