Australian biotechnology company Vaxxas has completed enrollment for its largest clinical trial to date, testing the safety and immune response of its high-density microarray patch (HD-MAP) for vaccine delivery.
The Phase I trial involves 258 healthy participants between the ages of 18 and 50 and focuses on a vaccine against avian influenza A (H7N9), a virus with pandemic potential.
The trial is designed to compare the HD-MAP’s vaccine delivery method to conventional needle-and-syringe injections.
Vaxxas’ technology delivers vaccines to the skin, potentially offering advantages such as increased consumer preference, reduced reliance on cold-chain storage, and ease of self-administration.
The company has stated that these benefits could contribute to a more rapid and widespread vaccination response in future pandemics.
The study is being conducted with funding from the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response, specifically through the Biomedical Advanced Research and Development Authority (BARDA).
The contract, valued at $28.5 million, has supported the completion of enrollment, which accounts for approximately 85 per cent of the total project funding.
Participants in the trial will receive either an adjuvanted or non-adjuvanted formulation of the A(H7N9) vaccine.
Adjuvants are used in some vaccines to enhance immune response, particularly in individuals who have not previously been exposed to the targeted virus.
If successful, the findings could pave the way for the development of HD-MAP vaccines that incorporate or omit adjuvants based on disease-specific needs.
David Hoey, CEO and President of Vaxxas, highlighted the potential impact of the technology. “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 dose, with no adjuvant, by delivering the vaccine directly to the immune cells just below the skin surface,” Hoey said.
“These promising results give us hope that the unadjuvanted formulation in this trial will be comparable to adjuvanted formulations delivered by needle and syringe. Additionally, if the adjuvanted HD-MAP formulation proves safe and elicits superior immune responses, it will create new opportunities to target a broader range of infectious diseases,” he explained.
Research from the Avalere Group suggests that alternative vaccine delivery methods like HD-MAP could significantly impact pandemic outcomes.
Their analysis indicated that during the COVID-19 pandemic in the United States, a 10 pe cent uptake of HD-MAP technology could have shortened the outbreak by up to 150 days, preventing an estimated 16.4 million cases, 200,000 deaths, and reducing economic losses by more than $500 billion.
Initial results from the trial are expected in the first half of 2025.
