Vaxart launches PhI clinical trial for norovirus tablet vaccine


Vaxart has been keeping busy with R&D for its oral vaccines, and now, the company is adding another project to its list. The South San Francisco-based biotech is launching a Phase I clinical trial of its oral vaccine for norovirus.

The randomized, double-blind trial, placebo-controlled study will look at how well Vaxart’s tablet vaccine works in warding off norovirus in 66 healthy adult volunteers. The company plans to follow the participants for a year to evaluate the vaccine’s safety and will examine “a broad range of systemic and local immune responses” through the study, Vaxart said in a statement.

Launching the trial marks “another important milestone” for Vaxart, CEO Wouter Latour said in a statement. The company is already working on tablet vaccines for RSV and seasonal flu. Adding a vaccine for norovirus would create “the ultimate trifecta in the vaccine sector” by improving large vaccination campaigns, boosting vaccine uptake and cutting costs, Latour said.

A tablet vaccine for norovirus would address a major healthcare issue. Norovirus causes about 19 to 21 million illnesses in the U.S. each year, which result in 56,000 to 71,000 hospitalizations and 570 to 800 deaths, according to numbers from the CDC cited by Vaxart. There are no norovirus vaccines approved by the FDA, so the company’s oral candidate could fill a gap in care.

In the meantime, Vaxart is also looking to other fields for vaccine development. In March, the company kicked off preclinical trials for its oral Zika vaccine tablet. Vaxart markets the tablet vaccine as superior to other jabs for the virus, as it’s temperature-stable and can shipped and stored without refrigeration.

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