Vaxart has commenced participant recruitment in the Phase II clinical trial of S-only oral tablet vaccine candidate for Covid-19.
This month, the company expects to start dosing the first of 96 US volunteers categorised equally between Covid 19 naïve and messenger ribonucleic acid (mRNA) vaccinated participants.
The Phase II Covid-19 programme will also be conducted outside of the US. In the initial stage, a trial is expected to be launched in India later this year.
Vaxart founder and chief scientific officer Dr Sean Tucker said: “We’re very excited to start Phase II trials of our S-only vaccine candidate because in our nonhuman primate studies, our S-only vaccine produced much higher serum antibody levels than the S+N construct did.
“Vaxart’s new trials will generate key data that will allow us to compare the S-only and S+N vaccine candidates and help us decide on the best development path forward for our Covid 19 vaccine programme, particularly in the face of emerging variant strains.”
The company’s vaccines are created to be used as tablets that require no refrigeration for storage and shipping.
Vaxart CEO Andrei Floroiu said: “An oral vaccine has the potential to dramatically impact the world’s response to the Covid 19 pandemic and to improve global public health.
“It can be easier and faster to administer than injectables and can help mitigate vaccine hesitancy, as many of those unwilling to get vaccinated by needle would take an oral tablet vaccine.”
Vaxart’s tablet vaccine delivery platform can potentially offer recombinant vaccines, aiding the company to create oral formulations of presently sold vaccines and to develop recombinant vaccines for novel indications.
At present, the development programmes of the company comprise tablet vaccines to offer protection against coronavirus, seasonal influenza, norovirus and respiratory syncytial virus (RSV).
Vaxart is also developing a therapeutic human papillomavirus (HPV) vaccine.
In September last year, Vaxart received clearance from the US Food and Drug Administration to conduct a Phase I trial of its Covid 19 vaccine candidate.