US-based biotechnology firm Vaxart has started enroling patients in a Phase I trial to evaluate its influenza B tablet vaccine.
The company develops oral recombinant vaccines that are administered by tablet rather than injection.
According to the company, the Phase I trial is a major step towards the development of quadrivalent flu tablet vaccines.
Quadrivalent vaccines are designed to help prevent two different types of influenza A strains, and two types of influenza B strains.
The vaccines provide broader protection by covering four influenza virus strains, which is one more than that covered by trivalent vaccines.
Vaxart chief medical officer Dave Liebowitz said: “The results of the influenza A Phase I trial suggest the room temperature-stable tablet vaccine may be as protective as currently marketed influenza vaccines while offering substantial advantages in distribution and ease of administration.
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“Because our influenza B vaccine is based on the same platform, we anticipate it will generate robust systemic and mucosal immune responses in humans as well.
“The influenza B vaccine represents the last individual monovalent component we need to evaluate in order to move forward with the development of our quadrivalent influenza tablet vaccine.”
Data from a recent influenza A Phase I trial showed that the compnay’s influenza A tablet vaccine generated both neutralising antibodies as well as a robust mucosal immune response in 92% of subjects after a single dose.
Vaxart CEO Wouter Latour said: “Just a few months ago, we closed a contract with BARDA to conduct a Phase II challenge study designed to demonstrate that the Vaxart tablet vaccine can provide broader and more durable protection than currently marketed vaccines.
“In parallel, we successfully completed preclinical development of our norovirus and RSV vaccine candidates, and both are scheduled to enter the clinic in 2016.
“All Vaxart vaccines are administered by tablet, which could be a game changer for these important indications.”
The company has been awarded a $13.98m contract from the Office of BARDA, the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
Under the contract, Vaxart will support the development of more effective and universal influenza vaccines to improve protection against seasonal and pandemic influenza.
The contract will primarily fund a Phase II study, which is designed to evaluate the strength of the company’s tablet against injectable vaccines.