Phase 1 clinical trial, expected to start in 2022, to include more than 400 adult volunteers using unadjuvanted and adjuvanted influenza vaccines
A patch that could administer vaccines without traditional needles will receive development support from the US Department of Health and Human Services (HHS).
A release from the US HHS informs that under an approximately $22 million, three-year agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the US HHS Office of the Assistant Secretary for Preparedness and Response, and Vaxxas – headquartered in Brisbane, Australia with offices in Cambridge, Massachusetts – the company will undertake US and Australian Phase 1 clinical trials to evaluate the safety and efficacy of an easy-to-use, high-density micro-array patch (HD-MAP) and other development activities for the patch.
“Protecting health and saving lives in public health emergencies such as pandemics often requires rapid, widespread vaccination among large groups of people, which poses multiple logistics challenges,” said Gary Disbrow, acting director, BARDA. “Imagine placing a patch on your arm or leg instead of having to go to a clinic or doctor’s office to get a shot. Not only would needle-free technology simplify vaccination logistics and potentially lower costs, but a self-administered patch also may improve vaccination rates.”
Micro-array patch technology has the potential to reduce the amount of vaccine required, which would help healthcare professionals provide vaccine to more people, an important consideration in a public health emergency. Patch technology also has the potential to offer a room-temperature-stable alternative to the cold chain required for some traditional vaccines, reducing the need for refrigeration in transport and storage, stated the release.
A room-temperature product that does not use traditional needles and syringes could possibly be provided directly to consumers who could administer the vaccine patch themselves. This technology could reduce the need for needles and syringes used for the majority of immunisations which may reduce the cost of vaccinations, and would simplify vaccine administration.
The Phase 1 clinical trial, expected to start in 2022, will include more than 400 adult volunteers using unadjuvanted and adjuvanted (which includes an added agent to boost immune response) influenza vaccines. The release notes that by using pre-pandemic influenza vaccines for the clinical trials, the company more easily can determine the baseline immune response and safety of the micro-array technology, as well as the usability and acceptability of the technology.
HD-MAP is the latest next-generation technology to receive BARDA development support and part of a growing pandemic preparedness and response portfolio.