Doherty Clinical Trials to Conduct Phase I Trial of Needle-Free Avian Influenza Vaccine
Key Insights
Doherty Clinical Trials (search) initiates a Phase I clinical trial for a needle-free avian influenza (search) vaccine developed by Vaxxas (search), assessing its safety and tolerability.
The trial utilizes Vaxxas (search)' High-Density Microarray Patch (HD-MAP) technology, delivering the vaccine to immune cells just below the skin surface.
The study involves 258 healthy volunteers and aims to evaluate the potential for improved vaccine delivery, thermostability, and ease of self-administration.
Doherty Clinical Trials (search) has commenced a Phase I clinical trial to evaluate an Australian-developed needle-free vaccine for avian influenza (search). The study will assess the safety and tolerability of the vaccine, which is administered using Vaxxas (search)’ High-Density Microarray Patch (HD-MAP) technology.
Innovative Vaccine Delivery System
The HD-MAP technology represents a departure from traditional needle and syringe methods. Instead of injecting the vaccine into a muscle, the HD-MAP delivers it to the immune cells immediately below the skin surface. This approach has shown promise in previous Phase I trials involving vaccines for seasonal influenza, COVID-19 (search), and measles (search) and rubella (search).
Potential Benefits of HD-MAP Technology
Early studies suggest that the HD-MAP technology is user-friendly and offers the potential for vaccines to remain stable at room temperature. This could reduce the need for cold-chain refrigeration and facilitate vaccine distribution via mail or courier for self-administration. According to Vaxxas (search) CEO David Hoey, this technology could enable a faster and broader vaccination response in the event of a future pandemic, accelerating vaccination uptake and rates.
Trial Details and Participant Involvement
The Phase I trial is Vaxxas (search)’ largest to date, enrolling 258 healthy participants aged 18 to 50 years across multiple clinical trial sites. Participants will attend nine scheduled visits over a 13-month period at Doherty Clinical Trials (search)’ facility in East Melbourne, where they will undergo thorough medical examinations, including physical assessments, vital sign measurements, and blood tests. Participants will receive reimbursement for their time and expenses.
Expert Perspectives
Dr. Andrew Brockway, CEO of Doherty Clinical Trials (search), expressed enthusiasm for collaborating with Vaxxas (search) on this novel vaccination product, highlighting its potential to significantly impact the response to future pandemics. Professor James McCarthy, Chief Medical Officer at Doherty Clinical Trials, noted that this new vaccine delivery method could mitigate some limitations associated with traditional vaccination approaches.
Avian Influenza and the Need for Effective Vaccines
All strains of avian influenza (search), commonly known as ‘bird flu,’ pose a potential threat to humans. Vaccination remains the most effective safeguard against the virus. While most human infections are mild or asymptomatic, severe symptoms can occur. Since early 2013, the World Health Organization (WHO) reports that over 1,500 people have been infected with avian influenza A worldwide.
Additional Trial Sites
The study also involves three University of Sunshine Coast Trial centers in Brisbane, Morayfield, and the Sunshine Coast.