Biotechnology firm Vaxart has started dosing participants in a Phase I clinical trial of oral tablet Covid-19 vaccine candidate, VXA-CoV2-1.
Biotechnology firm Vaxart has started dosing participants in a Phase I clinical trial of oral tablet Covid-19 vaccine candidate, VXA-CoV2-1.
VXA-CoV2-1 is a room temperature stable oral tablet, unlike other vaccines, which require cold storage. It can potentially ease problems such as distribution and administration of cold chain dependent injectable vaccines.
The open-label, dose-ranging trial (NCT04563702) will analyse the safety and immunogenicity of two doses of VXA-CoV2-1 in up to 48 healthy participants aged between 18 and 54. Vaxart expects to complete enrolment for the trial by next month.
The participants will be given a low or high dose of VXA-CoV2-1 oral tablet on days one and 29 of the trial.
During the active phase, safety, reactogenicity and immunogenicity assessments will be conducted at set times.Vaxart founder and chief scientific officer Sean Tucker said: “We are advancing VXA-CoV2-1 into clinical development based on the strength of preclinical 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.
“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 plans to release the initial data readout from the trial in a few weeks.
In September this year, Vaxart received clearance from the US Food and Drug Administration (FDA) to conduct the Phase I clinical trial. Approval was given after the company submitted an investigational new drug (IND) application in August.
