Oral Tablet COVID-19 Vaccine Clinical Study Doses Initial Patients

South San Francisco-based Vaxart, Inc. today announced that it had dosed the first subject in its Phase II COVID-19 oral tablet vaccine clinical trial, the only Phase II trial of an oral tablet COVID-19 vaccine underway in the world.

Vaxart stated in a press release it expects to enroll 96 subjects at four sites in the U.S. in the first part of its Phase II trial.

"Dosing the first subjects with the most advanced oral tablet COVID-19 vaccine candidate marks another important step forward toward developing a transformative solution to the SARS-CoV-2 global pandemic," stated Andrei Floroiu, Vaxart's CEO. 

"Vaxart's oral vaccine has the potential to transform public health both in the United States and globally by getting more people vaccinated faster while also offering broader protection by triggering mucosal immunity. This could help us fight emerging strains, break through the barriers to herd immunity and move toward domestic and global vaccine equity," Floroiu said.

The U.S. portion of the trial will be a randomized open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects, followed by an international placebo-controlled efficacy trial. 

The complete data set from the U.S. trial is expected in Q1 2022.

"A vaccine that can inhibit infection in the mucosal surfaces provides potentially better protection against airborne viruses because the mucosa is the body's first line of defense against these pathogens," added Dr. Sean Tucker, Vaxart's founder and Chief Scientific Officer.

"The mucosa is where the virus invades, and if we can stop it there, we can keep people healthier and fight off this virus and its variants."

The oral COVID-19 vaccine targets both the spike protein (S) and nucleoprotein (N). The N protein is more conserved and less prone to mutations than the S protein. Therefore new viral variants may be less likely to escape protection. The N protein is also a good target for T-cell responses.

Potent T-cell responses alone may offer multivariant protection against severe COVID-19 illness.