Vaxxas has completed enrollment for its Phase 1 clinical trial of a vaccine against an avian influenza A (H7N9) virus with pandemic potential, delivered by the company’s proprietary high-density microarray patch (HD-MAP).
The multi-centre clinical trial has enrolled 258 healthy participants between the ages of 18 and 50, making this study the largest Phase 1 study conducted to date by Vaxxas with its HD-MAP vaccination technology.
Vaxxas’ HD-MAP delivery of vaccines to the skin offers many potential benefits over traditional needle-and-syringe vaccination, including consumer preference, reduced need for complex and expensive cold-chain storage and distribution, and the potential for self-administration via an easy-to-use applicator, all of which could support a quicker and broader vaccination response to a future pandemic.
This project has been funded in whole or in part with federal funds from the US Department of Health and Human Services with US$28.5 million.
The trial will evaluate the safety and immune response of participants to the A(H7N9) vaccine when vaccinated using Vaxxas’ novel HD-MAP compared to conventional needle and syringe vaccine delivery.
This trial also represents the first time Vaxxas will evaluate the response to an adjuvanted vaccine formulation delivered with its HD-MAP technology. Adjuvants are typically used in pandemic vaccines to boost the immune response of participants who have never encountered the targeted virus before.
Some participants in the trial will receive an adjuvant-free formulation, while others will receive an adjuvanted vaccine formulation. If each formulation is safe and effective, it will enable the company to develop vaccines with and without adjuvants for administration by its HD-MAP technology to target a wider range of potential infectious diseases.
“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,” said Vaxxas and CEO and president David Hoey. “These promising results give us hope that the unadjuvanted formulation we’re using in this trial will be comparable to adjuvanted formulations delivered by needle and syringe. In addition, if the adjuvanted HD-MAP formulation is safe and produces superior immune responses, it will open new opportunities to target a broader range of infectious diseases with HD-MAP vaccines.”