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Prepping for a pandemic: Nanopatch receives funding for independent clinical trails

University of Sydney researchers have been awarded $1.12 million in funding via the Innovative Manufacturing CRC (IMCRC) to undertake independent clinical research studies to understand the potential of needle-free vaccine delivery for at-risk groups.

This grant reflects matched funding from Commonwealth Government funded IMCRC and Vaxxas, the Australian biotechnology company that developed the needle free delivery system – the Nanopatch™.

The two upcoming clinical studies are designed to evaluate the safety, feasibility, acceptability and usability of self-administering the Vaxxas’ vaccine delivery technology using an inactive substance. They will focus on older adults and healthcare professionals who are more likely to be impacted by pandemic influenza and SARS-COV-2.

The Nanopatch has been developed using Microscopy Australia’s University of Queensland facility, the Centre for Microscopy and Microanalysis, along with support from fellow NCRIS facility, ANFF. The device is one square-centimetre of biocompatible polymer, smaller than a postage stamp, covered in thousands of micro-projections which are invisible to the naked eye. These can be coated with a vaccine formulation, with the goal of penetrating the protective outer layer of the skin to deliver the vaccine to cell layers immediately under the skin, rich in immune cells. For more information on the device and microscopy performed please see the nanopatch impact story.

Lead researcher Prof. Rachel Skinner said the device presents advantages compared to vaccination using a needle and syringe. “The goal is for the device to only require a small dose of vaccine to generate the same level of immune response in the recipient,” said Prof. Skinner. “The device doesn’t require refrigeration making it easy and cheap to transport and store. It is designed to be simple to use, with the potential to be self-administered.”

Cristyn Davies, a Research Fellow in the Faculty of Medicine and Health and Kids Research, said the trials aim to simulate vaccination in a pandemic situation, focusing on priority groups susceptible to infection such as the elderly, and healthcare workers who are required to care for infectious patients.

David Chuter, CEO and Managing Director of IMCRC, highlighted the importance of the studies in expediting the refinement of the design and manufacturing of the device. “With Vaxxas planning to begin manufacturing the new needle-free vaccine delivery technology by early 2022, this IMCRC research project is vital to refine the device and fast-track its commercialisation process. These studies will assess the safety and acceptability of managing this technology within the healthcare community, with the results being fed back into the design and manufacturing process which is currently set up in Australia.”

Colour-enhanced scanning electron micrograph of the High-Density Microarray Patch (HD-MAP, previously Nanopatch™) (green) coated in vaccine (yellow).