Vaxart announced complete Phase 2b results for its oral norovirus vaccine candidate, demonstrating safety and efficacy against infection. The study met five of six primary endpoints, including a statistically significant reduction in norovirus infection. Machine learning analysis identified key correlates of protection, informing the development of Vaxart’s second-generation vaccine candidate, currently in Phase 1 trials.
This positive data strengthens the case for oral vaccines, especially for norovirus, a highly contagious illness with no approved vaccine. A convenient oral pill format could significantly improve vaccination rates, particularly in vulnerable populations like children or the elderly, offering broader public health benefits. The identification of correlates of protection via machine learning represents a significant advancement, enabling more efficient vaccine development and potentially predicting efficacy earlier in the clinical trial process.
The Phase 2b trial demonstrated a 30% reduction in norovirus infection and a 21% reduction in norovirus gastroenteritis, though the latter was not statistically significant. The vaccine also elicited robust immune responses, including increased IgA and IgG antibodies in serum, saliva, nasal lining fluid, and the intestine. Importantly, the vaccine was safe and well-tolerated, with mostly mild adverse events reported.
These findings pave the way for further clinical investigation of Vaxart’s second-generation norovirus vaccine. The incorporation of machine learning-derived correlates of protection offers the potential for a more efficacious vaccine and accelerates the development timeline. This progress positions Vaxart as a leader in the pursuit of an effective norovirus vaccine, addressing a significant unmet medical need.
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.
