Vaxart Launches New Phase 2b Trial to Test Oral Vaccine
Vaxart Initiates New Phase 2b Clinical Trial for Oral COVID-19 Vaccine
Vaxart, Inc. today has exciting news regarding its development in the realm of oral vaccines. The company announced the commencement of the sentinel cohort for its Phase 2b clinical study which focuses on evaluating an oral pill vaccine candidate for COVID-19. This trial will compare the efficacy, safety, and immunogenicity of Vaxart’s innovative oral vaccine against an approved mRNA vaccine. This significant milestone highlights Vaxart's ambition to contribute to a sustainable solution against the ongoing COVID-19 pandemic.
The Sentinel Cohort and Trial Overview
The Phase 2b clinical trial has been allocated funding as part of a larger initiative with a value of up to $456 million. This project is under the sponsorship of the U.S. government through the Rapid Response Partnership vehicle, as part of Project NextGen. The opening phase involves enrolling 400 healthy adult participants from the United States, split evenly between the Vaxart oral candidate and the standard mRNA vaccine comparator.
What to Expect from the Trial
Dr. James F. Cummings, Vaxart’s Chief Medical Officer, expressed optimism about the trial, stating that initiating this sentinel cohort is a pivotal step in their objective to develop an effective vaccine against COVID-19. The trial is designed to be double-blind and multi-center, ensuring the results are scientifically rigorous and reliable.
According to the trial structure, participants will be carefully monitored by an independent Data and Safety Monitoring Board (DSMB). Once the safety data from the initial 400 participants is reviewed, the trial can expand to include a total of 10,000 participants. This comprehensive approach aims to capture a broad demographic, particularly emphasizing senior participants aged 65 and older for inclusion.
Trial Goals and Measurement Objectives
The primary goal of the full Phase 2b trial is to measure the vaccine's efficacy in preventing symptomatic COVID-19 disease, while also examining asymptomatic cases, immune responses, and adverse events. Notably, the primary endpoint focuses on the efficacy of Vaxart's oral vaccine candidate compared to the injectable mRNA vaccine for symptomatic disease prevention. The primary efficacy analysis will take place 12 months after participants receive their vaccinations.
Funding and Government Support
The funding for this ambitious project stems from Project NextGen, a $5 billion federal initiative aimed at fast-tracking the development of cutting-edge COVID-19 vaccines and treatments. This initiative is spearheaded by the Biomedical Advanced Research and Development Authority (BARDA) alongside the National Institute of Allergy and Infectious Diseases (NIAID). Through this partnership, Vaxart aims to leverage government support to make strides in combating COVID-19 effectively.
About Vaxart and Its Innovative Approach
As a pioneer in the field of oral vaccines, Vaxart has established itself as a leader in the biotechnology industry. The company’s focus on oral vaccine delivery provides an innovative solution that can enhance accessibility and reduce delivery challenges associated with traditional injectable vaccines. Vaxart's platform not only caters to the development of vaccines for COVID-19 but also extends to other viruses such as norovirus and influenza, as well as therapeutic vaccines targeting human papillomavirus (HPV).
Vaxart's visionary approach aims to revolutionize vaccine delivery, with features that allow vaccine pills to be stored and distributed without refrigeration, minimizing the risk of needle-stick injuries—a significant benefit for public health.
Frequently Asked Questions
What is Vaxart's new trial about?
The trial evaluates the effectiveness of Vaxart's oral COVID-19 vaccine compared to an approved mRNA vaccine.
How many participants will be involved in the trial?
The trial plans to enroll 10,000 participants in its second phase, following an initial sentinel cohort of 400.
What funding supports this trial?
The trial is funded through Project NextGen, a $5 billion initiative by the U.S. government.
What is the main focus of the Phase 2b trial?
The trial focuses on the vaccine's efficacy, safety, and immunogenicity in preventing symptomatic COVID-19 disease.
What is Vaxart's expertise in vaccine development?
Vaxart specializes in developing oral vaccines using its proprietary delivery platform, targeting various viral infections.
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