The H1N1 influenza tablet vaccine created by Vaxart, Inc. is part of a broad range of vaccines being created by the privately held clinical-stage company.
Based on the company’s proprietary oral recombinant vaccines platform, Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration, are easy to administer and reduce medical waste. They also negate needle-stick injuries associated with injectable vaccines, according to the southern San Francisco-based company.
Most recently, the Vaxart H1N1 flu tablet vaccine received positive results from its Phase 1 clinical trials.
"Now that we have shown for the first time that the oral vaccine is plausible, it is a platform we are keen to develop for other indications, such as norovirus and RSV,” Vaxart CEO Wouter Latour told Vaccine News Daily.
“We have both those programs and will advance them to conduct clinical trials in 2016," Latour said.
RSV, or respiratory syncytial virus, infects the lungs and breathing passages and may cause upper respiratory infections such as colds, and lower respiratory tract infections, such as bronchitis and pneumonia. Norovirus is the leading cause of disease outbreaks from contaminated food in the United States, according to the Centers for Disease Control and Prevention.
During its Phase 1 clinical trial of its oral H1N1 influenza vaccine, the Vaxart H1N1 influenza tablet vaccine increased protective immunity using Hemagglutinin Inhibition Assay (HAI) along with HAI titer. HAI titers are used by the U.S. Food and Drug Administration (FDA) and the health industry for determining protective immunity.
"Subjects were dosed just one time with the vaccine,” Latour told Vaccine News Daily, and patients experienced only mild adverse events.
“Certainly, the objective of a vaccine is to work well with one administration," Latour said.
The tablet vaccine showed better results than the traditional, approved influenza vaccines.
"Studies for oral vaccines are very comparable to the injectable vaccines," Latour said.
Additionally, the new H1N1 tablet vaccine also showed a promising tolerability and safety profile.
"We have a really defined development plan,” Latour said. “It is much easier to distribute and administer it simply by just having the tablet form."