Vaxart, Inc, a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced today the initiation of a Phase 1 clinical trial of the first oral respiratory syncytial virus (RSV) tablet vaccine.
“The start of the RSV Phase 1 study is a significant milestone for Vaxart’s oral vaccine platform,” said Wouter Latour, MD, chief executive officer of Vaxart. “We previously demonstrated that our oral H1N1 influenza tablet vaccine has the potential to outperform commercially available flu vaccines. Now, we are entering the clinic with an oral RSV tablet vaccine based on the same platform. This establishes Vaxart as a leading innovator in the respiratory vaccines space, and we look forward to the results of this study with great anticipation.”
The randomized, double-blind, placebo-controlled Phase 1 dose-ranging study will assess the safety and immunogenicity of Vaxart’s F-protein based RSV tablet vaccine in 66 healthy adult volunteers. Study participants will be followed for 12 months for safety, and a broad range of systemic and local immune responses will be evaluated at multiple time points over the study.
“In preclinical studies, our RSV vaccine generated robust immune responses and provided complete protection against infection,” said David Liebowitz, MD, PhD, chief medical officer of Vaxart. “RSV is an important public health indication and we believe a tablet vaccine would be ideal for immunizing large populations, especially the elderly and at-risk adults where RSV causes considerable disease and mortality.”