Vaxart Initiates Phase 2b Study of Oral COVID-19 Vaccine
Part 1 of James F Cummings, MD interview, discusses the trial's goals and highlights the vaccine's potential to generate mucosal immunity, its logistical advantages and ease of administration.
Vaxart has announced the initiation of a sentinel cohort for its Phase 2b clinical trial, evaluating the safety, immunogenicity, and efficacy of its oral COVID-19 vaccine candidate compared to an approved mRNA vaccine. Valued at up to $456 million under Project NextGen, this trial aims to address ongoing challenges posed by COVID-19. The study will assess factors such as efficacy against symptomatic and asymptomatic COVID-19, immune responses, and the incidence of adverse events. The primary endpoint will focus on the relative efficacy of Vaxart’s vaccine for preventing symptomatic disease, with analysis expected 12 months post-vaccination.
James F Cummings, MD, chief medical officer of Vaxart, he highlighted the significance of this milestone, stating, “Initiating the sentinel cohort is a strong step toward Vaxart’s goal of developing a vaccine that may bring us closer to a sustainable solution to the persistent threat of COVID-19. We continue to progress toward our goal of conducting the Phase 2b study and look forward to the results of our mucosal technology’s first head-to-head comparison against an approved mRNA vaccine for this virus.”1
The first phase will enroll 400 participants: 200 receiving Vaxart’s oral vaccine candidate and 200 receiving the approved mRNA vaccine. Following a 30-day safety review by an independent Data and Safety Monitoring Board (DSMB) and the FDA, the trial will advance to a second phase aiming to enroll an additional 10,000 participants, ensuring demographic representation, including at least 25% of those over 65 years of age.
In the first part of our two-part interview with Cummings, he discussed how the oral COVID-19 vaccine enhances immune response compared to traditional injections and shared insights on its potential benefits for public health. He noted, “Another one is the fact that the way our vaccine works, it exhibits a mucosal immune response as well as a serum response,” emphasizing the significance of mucosal immunity in providing a first line of defense against pathogens.
Cummings also emphasized the advantages of their oral vaccine platform, “It's a pretty neat idea, and that we have a pill-based form that’s thermally stable. This is something that has stability at room temperature and doesn’t require a needle, syringe, or any medical professional to administer. From start to finish, it’s a very economical way of fielding a vaccine for global health,” he said.
Additionally, Cummings highlighted the logistical benefits, stating, “having something that could be as easy as sending them in the mail or ubering it to someone, or however you would want to deliver it, I think makes distribution, the logistics of vaccine delivery a lot easier. I think that's one of the benefits of the platform.”
Stay tuned for part two of our interview, where we will explore the key safety and effectiveness measures that will be evaluated in the trial, their relevance to current needs in the fight against COVID-19, and how the trial will ensure representation of various age groups and health conditions. We will also discuss what the results could imply for future vaccines.
More About Funding and Vaxart
Funding for this initiative is provided by Project NextGen, an effort led by BARDA and NIAID to accelerate the development of next-generation COVID-19 vaccines and therapeutics. Vaxart stands out as the first US company to complete a Phase 2 clinical trial for an oral COVID-19 vaccine, showcasing its leadership in oral vaccine development. The company is also advancing oral vaccines for norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus.
