‘Needle-Free’ Bird Flu Vaccine Trial Begins in Australia With US Backing

Participants dosed with the vaccine will be tested for their response to ‘pre-pandemic avian influenza strain H7N9.’

A person holds a test tube labelled "Bird Flu", in this picture illustration, on January 14, 2023. REUTERS/Dado Ruvic/Illustration/File Photo

An Australian and U.S. biotech company will trial a new bird flu vaccine that does not require a needle for injection.

Vaxxas will conduct the clinical study at multiple Australian clinical sites with oversight from the U.S. Biomedical Advanced Research and Development Authority (BARDA).

The vaccine company received $43 million (US$28.5 million) from the U.S. government to conduct the trial in response to “future pandemic threats.”

The phase one clinical trial will test a vaccine that can be administered via a skin patch and a small applicator device.

Known as the High-Density Microarray Patch (HD-MAP), the system delivers the vaccine to immune cells immediately below the skin service, targeting the immune systems directly. This can potentially improve the immune response compared to traditional needle based injections.

“The trial will compare the safety and immune response of participants to the pre-pandemic avian influenza strain H7N9 when dosed with Vaxxas’ novel HD-MAP as well as through conventional needle and syringe,” Vaxxas said.

Commenting on the trial, 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,” he said.

The company said “all strains of avian influenza, or bird flu, including H7N9 and H5N1, represent a potential serious pandemic threat to livestock and humans.”

258 Volunteers Will Take Part in Study

The clinical study will involve 258 healthy individuals between the age of 18 to 50 years, representing the largest phase one trial conducted by Vaxxas to date.

It will involve three University of the Sunshine Coast’s clinical trial centres in Queensland and the Doherty Clinical Trial centre in Melbourne, Victoria.

They are currently recruiting healthy volunteers to take part in the phase one clinical trial. Participants will need to visit the Doherty Clinical Trials’ facility in East Melbourne for nine scheduled visits across a 13-month period.

“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,” the Doherty Institute said.

“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.”

The Institute said early studies have shown the technology to be simple to use with the potential for vaccines to be stable at room temperature.

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.”

Professor James McCarthy, Chief Medical Officer at Doherty Clinical Trials, added, “This innovative vaccine delivery approach is poised to overcome many limitations associated with traditional methods.”

Principal Investigator Dr. Nischal Sahai said the study would assess the safety and tolerability of the influenza vaccine, as well as the body’s immune response.

“It is anticipated that this mechanism of vaccine delivery may provide a quicker, more effective response from the immune system,” he said.

Results from the trial are expected in early 2025. Vaxxas and clinical partners will provide BARDA with initial results for publication.

Vaxxas is headquartered in Australia with an office in Cambridge, Massachusetts. The company has partnerships with Merck, BARDA, the World Health Organization (WHO), and the Bill and Melinda Gates Foundation.

Bird Flu In Australia

More than 1,568 people have been infected by H7N9 worldwide since early 2013.

The H7N9 high pathogenicity bird flu strain was detected on a poultry farm near Terang in Victoria in May. A H7N3 strain was also detected at seven Victorian poultry farms.

In addition, there were six outbreaks of H7N8 in NSW and two in the Australian Capital Territory.

On Sept. 12, Agriculture Victoria advised they had eased restrictions surrounding avian influenza cases in Victoria. No new cases have been detected since June 24.

Victoria’s Chief Veterinary Officer Graeme Cook said their efforts to monitor the disease continue however, with staff visiting properties and testing birds in control areas.

“‘As we continue to carry out ‘proof of freedom’ testing, we’re confident that this testing will not find any positive cases of high pathogenicity avian influenza, proving to the world that our flocks are safe,” he said.