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Doherty Clinical Trials is calling on healthy volunteers to participate in a new Phase I clinical trial of a needle-free vaccine for avian influenza. The trial will assess the safety and tolerability of the influenza vaccine administered using the needle-free technology developed by Australian biotech company, Vaxxas.
Unlike traditional needle and syringe administration, which is injected into a muscle, Vaxxas’ High-Density Microarray Patch (HD-MAP) technology delivers the vaccine to the immune cells immediately below the skin surface.
Previous Phase I trials of Vaxxas’ HD-MAP technology have shown promising results in administering vaccines including seasonal influenza, COVID-19, and measles and rubella.
In early studies, the technology has also shown to be easy to use with the potential for vaccines to be stable at room temperature, potentially reducing the need for cold-chain refrigeration and facilitating distribution of vaccine patches by mail or courier for self-administration. In the event of a future pandemic, the technology could enable a faster and broader vaccination response.
Vaxxas CEO David Hoey said: "Global pandemic threats require the world’s health organisations to have better and more accessible vaccine delivery options.
“With potential benefits such as thermostability, ease of use, and patient acceptability, Vaxxas’ HD-MAP is designed to be rapidly and broadly deployed to accelerate vaccination uptake and rates.”
This clinical study, enrolling 258 participants between the ages of 18 and 50 years, and involving multiple clinical trial sites, will be Vaxxas’ largest Phase I trial conducted-to-date with its HD-MAP technology.
Trial participants are required to be in good health and available to visit Doherty Clinical Trials’ facility in East Melbourne for nine scheduled visits across a 13-month period, where they will undergo a thorough medical examination by doctors, including a physical examination, measuring vital signs and conducting blood tests. Participants will be reimbursed for their time and expenses over the course of the study.
Doherty Clinical Trials CEO, Dr. Andrew Brockway said: “We are excited to be collaborating with an Australian biotech company developing a novel vaccination product that could play a significant role in the way we respond to future pandemics.
“If you are interested in being a part of supporting advances in vaccination technology, we’d love to hear from you.”
Doherty Clinical Trials’ Chief Medical Officer, Professor James McCarthy said: “This new way of delivering vaccines, such as influenza, is very exciting as it could reduce some of the limitations associated with vaccination via traditional methods.”
All strains of avian influenza, or ‘bird flu’ as it’s more commonly known, represent a potentially serious threat to humans, with vaccination remaining the most effective safeguard. Most infections in humans are mild or have no symptoms, similar to seasonal influenza, but occasionally symptoms can be severe.1
Since early 2013, over 1,500 people have been infected by avian influenza A worldwide, according to WHO.2
Other clinical sites involved in the study include three University of Sunshine Coast Trial centres in Brisbane, Morayfield and the Sunshine Coast.
As a not-for-profit registered charity and subsidiary of the University of Melbourne, Doherty Clinical Trials has been established by the Doherty Institute to accelerate the development of novel medicines and vaccines through bespoke early phase clinical trial solutions.
References
[1]Bird flu (avian influenza) fact sheet – Fact sheets (Last updated: 26July 2024) Gov.au. Available at https://www.health.nsw.gov.au/Infectious/factsheets/Pages/avian-influenza.aspx
[2] Avian influenza (no date) Who.int. Available at:https://www.who.int/westernpacific/wpro-emergencies/surveillance/avian-influenza
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