First patient dosed in COVID-19 vaccine tablet clinical trial
A Phase I clinical trial to test VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, has been initiated with the first patient dosed.
The Phase I, 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. Enrolment 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 one and 29. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase.
“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 Dr Sean Tucker, 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 study is expected to be completed in December and will have a 12-month safety follow-up period post last vaccination.
“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.”
According to the company, pre-clinical studies showed this oral vaccine candidate induces systemic and mucosal immunity which are crucial to preventing SARS-CoV-2 infection and transmission. The vaccine is completely stable at room temperature and does not require refrigeration for long term storage or distribution, making it less expensive and easier for governments to dispense and stockpile compared to traditional injectable vaccines.