Australian-American biotech Vaxxas has reached a significant milestone in its innovative vaccine delivery program, completing enrollment for a Phase I trial of its H7N9 avian influenza vaccine candidate. The study will evaluate a novel microneedle patch delivery system that could revolutionize vaccine administration.
The trial has successfully recruited 258 healthy volunteers between 18 and 50 years old to test VXS-1219, delivered through the company's proprietary high-density microarray patch (HD-MAP). This technology represents a potential breakthrough in vaccine delivery, featuring a self-administrable patch embedded with microscopic projections that deliver the vaccine directly to immune cells beneath the skin surface.
Strategic Response to Pandemic Preparedness
The development program has garnered substantial support from U.S. government agencies, securing $28.5 million in funding from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and BARDA. This investment reflects the strategic importance of developing effective responses to potential pandemic threats.
The timing is particularly relevant given recent developments in avian influenza transmission. The U.S. Centers for Disease Control and Prevention recently reported the first H5N1-related death in the country, highlighting the ongoing concern about bird flu variants. While H7N9, first identified in China in 2013, represents a different strain, both emphasize the need for robust vaccine development programs.
Trial Design and Previous Success
The study employs a comprehensive design to evaluate multiple aspects of the vaccine delivery system. Participants will be randomized to receive either an adjuvant-free or adjuvanted vaccine formulation, delivered via either traditional needle injection or the HD-MAP device.
David Hoey, CEO of Vaxxas, shared promising insights from previous research: "In our prior clinical studies for seasonal influenza, we've demonstrated comparable immune responses to traditional vaccination with as little as one-sixth of the vaccine with no adjuvant by delivering the vaccine directly to the immune cells just below the skin surface."
Building on Established Safety Profile
The current trial builds on encouraging results from previous studies. An earlier Phase I trial involving 120 healthy volunteers demonstrated that the HD-MAP system was well-tolerated and generated meaningful immune responses. This prior research tested the technology with a monovalent, split-inactivated influenza virus vaccine.
Market Context and Competition
In the specific H7N9 vaccine landscape, VXS-1219 faces limited competition, with only Pneumagen's Neumifil currently in Phase II trials. Market analysis suggests the global avian influenza vaccine market could reach approximately $25 million by 2030, though this projection could shift significantly depending on disease prevalence and public health needs.
