Vaxart Doses First Subject in Phase II COVID-19 Oral Tablet Vaccine Clinical Trial2 min read
October 26, 2021 at 8:00 AM EDT
Vaxart expects to enroll 96 subjects at four sites in the United States in the first part of its Phase II trial. The U.S. trial will be followed by an international trial involving a larger pool of subjects. The U.S. portion of the trial will be a randomized open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects, to be followed by an international placebo-controlled efficacy trial. The full data set from the U.S. trial is expected in Q1 2022.
“Dosing the first subjects with the most advanced oral tablet COVID-19 vaccine candidate marks another important step forward toward developing a transformative solution to the SARS-CoV-2 global pandemic,” said Andrei Floroiu, Vaxart’s Chief Executive Officer.
“Vaxart’s oral vaccine has the potential to transform public health both in the United States and globally by getting more people vaccinated faster while also offering broader protection by triggering mucosal immunity. This could help us fight emerging strains, break through the barriers to herd immunity and move toward domestic and global vaccine equity,” Floroiu said.
“A vaccine that can inhibit infection in the mucosal surfaces provides potentially better protection against airborne viruses because the mucosa is the body’s first line of defense against these pathogens,” said Dr. Sean Tucker, Vaxart’s founder and Chief Scientific Officer. “The mucosa is where the virus invades, and if we can stop it there, we can keep people healthier and fight off this virus and its variants.”
Vaxart has recently brought online its own GMP manufacturing facility and is now producing vaccines at two GMP plants in parallel. This allowed the company to manufacture all of the COVID-19 vaccine oral tablets for the clinical trials planned to start in 2021, and to start manufacturing vaccines for its upcoming norovirus Phase II trials.
Recent Pre-clinical Data
A Duke University-led study published earlier this month showed that Vaxart’s vaccine candidate reduced the airborne transmission of SARS-CoV-2 virus in an animal model and suggested the vaccine candidate would support superior mucosal protection.
The study’s findings, published by bioRxiv, are consistent with those from Vaxart’s Phase II human flu challenge study published in 2020. The flu study showed Vaxart’s oral tablet flu vaccine was better at reducing shedding than the injectable flu vaccine competitor. The Duke and flu studies’ data support the thesis that mucosal vaccines may offer better protection than injectable vaccines against airborne viruses.
VXA-COV2-1.1-S Phase II Trial Design
The Phase II study is designed to enroll 96 subjects aged 18-55 years old, and then enroll subjects aged 56-75 years old, in eight subgroups. Subjects will be randomized into eight cohorts stratified by age, vaccination history, dose size and placebo. The study drug will be an oral tablet administered on Days 1 and 29. The endpoints are safety, immunogenicity and efficacy. For more information, refer to ClinicalTrials.gov (NCT 05067933).