Vaxart has dosed the first participant in its Phase II clinical trial of an oral tablet vaccine for the treatment of Covid-19.
For the trial’s first part, 96 participants will be enrolled at four centres in the US.
The US part will be an open-label, randomised dose and age escalation lead-in segment in untreated and previously inoculated participants.
Participants aged 18-75 years will be categorised into eight arms based on their age, inoculation history, and dosage size to receive either the oral tablet vaccine or placebo on day one and day 29.
Safety, immunogenicity and efficacy are the goals of the trial.
The company anticipates complete results from the US trial in the first quarter of next year.
A global placebo-controlled efficacy trial will be initiated on concluding the US trial.
Vaxart founder and chief scientific officer Dr Sean Tucker said: “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 defence against these pathogens.
“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 company develops vaccines that can be administered as tablets, which can be stored and transported without requiring refrigeration while eradiating needle-stick injury risks.
Vaxart’s development programmes currently comprise tablet vaccines to offer protection against coronavirus, norovirus, seasonal influenza, respiratory syncytial virus and therapeutic vaccine for human papillomavirus.
Earlier this month, Vaxart initiated participant recruitment in the Phase II trial of the S-only oral tablet vaccine candidate to treat Covid-19.