Clinical-stage biotechnology company, Vaxart, Inc., announced that the first subject has been dosed in its Phase 1 study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate.
“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,” said Sean Tucker, Ph.D., chief scientific officer and founder of Vaxart. “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 Phase 1, open-label, dose-ranging trial (NCT04563702) is designed to examine the safety and immunogenicity of two doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old. Enrollment is expected to be completed by early November 2020, with participants 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.
“We are very excited about our oral tablet vaccine entering the clinic because we believe that the COVID-19 pandemic needs an oral alternative to injectable vaccines,” said Andrei Floroiu, chief executive officer of Vaxart. “Our room temperature stable oral tablet vaccine has the potential to ease many of the problems associated with distribution and administration of cold chain dependent injectable vaccines and may make herd immunity more achievable by making it much easier to vaccinate more people faster. We are looking forward to receiving the first clinical data in the next few weeks.”
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