Ocugen has received FDA approval to begin a Phase 1 clinical trial for OCU500, an inhaled and nasal spray vaccine for COVID-19. The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), will assess the vaccine’s safety, tolerability, and immunogenicity in 80 adult participants. This development leverages a novel chimpanzee adenovirus-vectored (ChAd36) technology for mucosal delivery, aiming to provide more durable protection against COVID-19.
Although the pandemic has officially ended, COVID-19 remains a serious health concern, causing significant hospitalizations and deaths. Developing a more effective and longer-lasting vaccine is crucial for mitigating the ongoing impact of the virus and preventing future surges. A mucosal vaccine, delivered directly to the respiratory system, offers a potentially superior approach to combatting COVID-19 compared to traditional intramuscular injections, by stimulating immunity at the point of viral entry.
The Phase 1 trial will involve two dose groups, with participants receiving either the inhaled or intranasal version of OCU500. This technology, licensed from Washington University in St. Louis, has shown promising results in earlier studies, including increased antibody production and sustained immune response with a lower dose compared to intramuscular administration. NIAID, through Project NextGen, will fully fund the trial, and Ocugen will retain rights to the findings. Ocugen plans to utilize this platform for other respiratory diseases like influenza and RSV.
This FDA approval marks a significant step forward for Ocugen and the development of next-generation COVID-19 vaccines. Positive results from the Phase 1 trial could pave the way for further clinical development and potentially offer a more effective and convenient method for protecting against COVID-19 and other respiratory illnesses. This innovative approach may be pivotal in mitigating the long-term impact of COVID-19 and improving preparedness for future respiratory virus outbreaks.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
