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Ph I trial of first needle-free influenza vaccine begins in Australia

13 February 2023 | News

Vaxxas initiates phase I study for needle-free seasonal influenza vaccine delivered using High-Density Microarray Patch (HD-MAP)

Australian biotech firm Vaxxas has announced the initiation of a Phase I clinical trial with the first inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate delivered using Vaxxas’ proprietary needle-free vaccine technology, the high-density microarray patch (HD-MAP).

The Phase I clinical trial will assess the safety, tolerability, and immunogenicity of an IIV4 candidate in approximately 150 healthy participants, aged 18 – 50 years inclusive, who have not received an influenza vaccine within the last six months and have received no vaccines of any kind for at least thirty days prior to participating in the study.

The trial is being conducted in Australia at three of the University of the Sunshine Coast’s clinical research locations in Brisbane, Morayfield and Sippy Downs. 

The vaccine being delivered by Vaxxas’ HD-MAP in the study is a seasonal influenza vaccine quadrivalent (IIV4) candidate. The specific strains of influenza virus targeted in any given seasonal IIV4 are established annually by regulatory health agencies and encompass two strains of influenza A and two strains of influenza B. By targeting four significant strains of the influenza virus, quadrivalent influenza vaccines are designed to offer broad immune coverage against the flu viruses expected to circulate across the globe for a given flu season.

In addition to this seasonal IIV4/HD-MAP Phase I clinical trial, Vaxxas is preparing for clinical evaluation of pandemic influenza vaccine under contract with the United States Biomedical Advanced Research and Development Authority (BARDA). In 2022, the company also initiated a Phase I clinical study of the first COVID-19 vaccine candidate delivered using its HD-MAP technology.


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