South San Francisco-based Vaxart announced today it has given its first participant its investigational, oral COVID-19 tablet vaccine, VXA-CoV2-1.
“We are advancing VXA-CoV2-1 into clinical development based on the strength of pre-clinical data that showed that the vaccine is capable of inducing both a robust systemic immune response and a strong mucosal immune response, specifically in the lungs,” Sean Tucker, PhD, chief scientific officer and founder of Vaxart, said. “We are eager to explore the clinical profile of VXA-CoV2-1 for effective protection against SARS-CoV-2 infection and transmission in healthy adults.”
The company has entered a phase 1, open-label, dose-ranging trial and is expecting to finish in November of this year. The trial is going to examine the safety and immunogenicity of 2 doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old.
All participants will be receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase.
Vaxart is a biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform.
Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). Vaxart’s first immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.