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ADVANCE Perspective: Respiratory Views

Potential Respiratory Syncytial Virus Vaccine on the Way from Vaxart

Published June 30, 2016 2:02 PM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras


ADVANCE has covered respiratory syncytial virus (RSV) consistently in the past year. Any why wouldn’t we? RSV is a major cause of severe respiratory infection in the elderly, in immunocompromised patients and in adults with other underlying medical conditions, and is the most common cause of acute lower respiratory infection in infants and young children.


Moreover, according to the Centers for Disease Control and Prevention (CDC), RSV causes 177,000 hospitalizations and 14,000 deaths among adults older than 65 in the United States each year and as of now, there are no U.S. Food and Drug Administration (FDA) approved RSV vaccines available.


All of that may be poised to change, however, thanks to Vaxart’s new initiation of a Phase 1 clinical trial of the first oral respiratory syncytial virus (RSV) tablet vaccine. Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines administered via tablet rather than injection.

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“The start of the RSV Phase 1 study is a significant milestone for Vaxart’s oral vaccine platform,” said Wouter Latour, MD, CEO 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.”


“In preclinical studies, our RSV vaccine generated robust immune responses and provided complete protection against infection,” added David Liebowitz, MD, PhD, and 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.”


According to a press release put out by Vaxart, “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.”


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Incidences of RSV in the general population — regardless of age — are high enough that the development of this oral vaccine would stand as a landmark accomplishment in the fight against it. Here’s hoping Vaxart’s Phase 1 study is as successful as its preclinical studies.


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