- The clinical study aims to evaluate a vaccine for avian influenza A (H7N9) delivered by Vaxxas’ high-density microarray patch (HD-MAP), and is funded by the United States government as a potential countermeasure for future pandemics;
- Led by Vaxxas’ team and clinical collaborators, this Phase I study is being conducted under an Investigational New Drug Application authorized by the U.S. Food and Drug Administration (FDA);
- Target enrollment of 258 healthy participants was achieved, making this the largest clinical trial involving HD-MAP vaccine delivery;
- The clinical trial is also the first to evaluate HD-MAP vaccine formulations with and without the inclusion of an adjuvant.
BRISBANE, Australia & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vaxxas, a clinical-stage biotechnology company, today announced it has completed enrollment for its Phase I clinical trial of a vaccine against an avian influenza A (H7N9) virus with pandemic potential, delivered by the company’s proprietary high-density microarray patch (HD-MAP). 
The multi-center clinical trial has enrolled 258 healthy participants between the ages of 18 and 50 years, making this study the largest Phase I study conducted to date by Vaxxas with its HD-MAP vaccination technology, which delivers vaccines to the skin of participants.
Vaxxas’ HD-MAP delivery of vaccines to the skin offers many potential benefits over traditional needle-and-syringe vaccination, including consumer preference, reduced need for complex and expensive cold-chain storage and distribution, and the potential for self-administration via an easy-to-use applicator, all of which could support a quicker and broader vaccination response to a future pandemic.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00180 in the amount of US$28.5 million. Total costs used for the completion of enrollment in the A(H7N9) influenza study is approximately 85% of the total contract value.
The trial will evaluate the safety and immune response of participants to the A(H7N9) vaccine when vaccinated using Vaxxas’ novel HD-MAP compared to conventional needle and syringe vaccine delivery.
This trial also represents the first time Vaxxas will evaluate the response to an adjuvanted vaccine formulation delivered with its HD-MAP technology. Adjuvants are typically used in pandemic vaccines to boost the immune response of participants who have never encountered the targeted virus before.
Some participants in the trial will receive an adjuvant-free formulation, while others will receive an adjuvanted vaccine formulation. If each formulation is found to be safe and effective, it will enable Vaxxas to develop vaccines with and without adjuvants for administration by its HD-MAP technology to target a wider range of potential infectious diseases.
“In our prior clinical studies for seasonal influenza, we’ve demonstrated comparable immune responses to traditional vaccination with as little as one-sixth of the vaccine with no adjuvant by delivering the vaccine directly to the immune cells just below the skin surface,” said David L Hoey, Vaxxas CEO and President. “These promising results give us hope that the unadjuvanted formulation we’re using in this trial will be comparable to adjuvanted formulations delivered by needle and syringe. In addition, if the adjuvanted HD-MAP formulation is safe and produces superior immune responses, it will open new opportunities to target a broader range of infectious diseases with HD-MAP vaccines.”
Research conducted by the Avalere Group shows that the COVID-19 pandemic in the United States could have been shortened by up to 150 days if just 10 percent of vaccinations were administered using HD-MAP technology, resulting in 16.4 million fewer cases, 200,000 fewer deaths and more than $500 billion reduction in economic impact to the US economy.
Initial results from the trial are expected in the first half of 2025.
About HD-MAP needle-free vaccines
The Vaxxas HD-MAP is comprised of thousands of microscopic projections molded into a small patch. Each microprojection is coated with a small dose of vaccine in a dried formulation. When applied to the skin using a proprietary, easy-to-use applicator, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface.
HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore potentially reducing the need for cold-chain storage and distribution.
Vaxxas’ HD-MAPs have proven safe and tolerable in hundreds of trial participants to date, and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle and syringe systems, HD-MAP vaccines are also much easier to administer and are likely to have greater acceptability by healthcare workers and vaccine recipients.
Ultimately, HD-MAPs could enable a future in which vaccine patches could be shipped directly to peoples’ homes, workplaces, and schools, avoiding the delay, inconvenience, and safety challenges associated with traditional needle-and-syringe vaccine scheduling and administration.
About avian influenza
This selected variant of avian influenza A (H7N9), or bird flu, is a subtype of influenza viruses that have been detected in birds, livestock, and people in the past.
H7N9 has an observed Infection Fatality Rate (IFR) of 39%, meaning for every 100 infected people 39 people are likely to die and many are likely to become seriously sick. To date, more than 1,500 people have been infected by H7N9 worldwide since early 2013, according to WHO.
About Vaxxas
Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious diseases and oncology.
With success in several completed human clinical trials involving more than 500 participants and other vaccine studies targeting pandemic influenza, funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services under contract number 75A50120C00180, Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization.
Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialisation group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by a further financing led by OneVentures with UQ joining the most recent financing.
OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at OneVentures and Brandon Capital.
CAUTION
The Vaxxas HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe, or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.
Contacts
MEDIA
Vaxxas - In United States:
Kathryn Morris
The Yates Network
+1 914 204 6412
kathryn@theyatesnetwork.com
Vaxxas - In Australia:
Amy Miller
WE Communication
+61 431 072 422
amymi@we-worldwide.com