The Food and Drug Administration (FDA) has cleared the path for a groundbreaking nasal COVID-19 vaccine, developed at Washington University in St. Louis, to begin Phase 1 clinical trials in the United States. The approval follows an investigational new drug application from Ocugen, Inc., which licensed the technology from WashU in 2022.
The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct the trial, planned to commence this spring as part of Project NextGen, a U.S. government initiative focused on developing next-generation COVID-19 vaccines through public-private partnerships.
Trial Design and Objectives
The study will enroll 80 participants aged 18-64 years, randomly assigned to four groups testing different administration routes and dosage levels:
- Low-dose intranasal
- High-dose intranasal
- Low-dose inhaled
- High-dose inhaled
While safety assessment is the primary endpoint, the trial will also measure antibody production and monitor breakthrough COVID-19 cases to evaluate efficacy.
Innovative Technology and Mechanism
The vaccine's development team, led by Dr. Michael S. Diamond and Dr. David T. Curiel at WashU Medicine, engineered the vaccine using a harmless adenovirus vector carrying a SARS-CoV-2 gene. This design enables the vaccine to stimulate immune responses directly in the nose and respiratory tract, where COVID-19 typically enters the body.
"It is gratifying to see the vaccine that we conceived, designed and conducted initial testing on move closer to becoming available here in the U.S.," said Dr. Diamond, who serves as the Herbert S. Gasser Professor of Medicine and co-director of the Center for Vaccines & Immunity to Microbial Pathogens.
Promising Preclinical Results
Preclinical studies conducted in 2020 and 2021 yielded encouraging results, demonstrating the vaccine's ability to prevent infection in the nose and lungs completely. Recent research by Dr. Jacco Boon at WashU Medicine showed that vaccinated hamsters did not transmit the virus to others, suggesting potential benefits for reducing community transmission.
Dr. Curiel, Distinguished Professor of Radiation Oncology, emphasized the broader implications: "All effective vaccines reduce sickness and death, but COVID-19 vaccination through the nose and mouth also seems to reduce transmission. This capability is critical in slowing the spread of respiratory infections."
Global Impact and Future Applications
The technology has already reached international markets, with a version available in India since 2022 through Bharat Biotech. Doug E. Frantz, PhD, Vice Chancellor for Innovation and Commercialization at WashU, highlighted the technology's potential broader applications: "This powerful technology has the potential not only to help control COVID-19 but to reduce the burden of respiratory infections worldwide, including seasonal influenza, avian flu, and respiratory syncytial virus (RSV)."
While COVID-19 cases have decreased since the pandemic's peak, the virus continues to cause significant illness and mortality. Current injectable vaccines, while effective at reducing severe disease, have limited impact on transmission. This nasal vaccine technology represents a potential breakthrough in addressing both disease severity and viral spread, marking a significant advancement in COVID-19 prevention strategies.
