Vaxxas, a clinical-stage biotech company, has completed enrollment for its Phase I clinical trial of an avian influenza A (H7N9) vaccine delivered via its high-density microarray patch (HD-MAP). This 258-participant trial, the largest Phase I study conducted by Vaxxas to date, compares the HD-MAP’s efficacy against traditional needle-and-syringe delivery. The study is partially funded by a US$28.5 million BARDA contract, with approximately 85% of the funds utilized for enrollment completion.
This trial holds significant implications for pandemic preparedness. The HD-MAP’s potential for self-administration, simplified logistics due to reduced cold-chain requirements, and increased patient comfort could dramatically improve vaccination rates and speed during a future pandemic. Evaluating both adjuvanted and non-adjuvanted vaccine formulations delivered via the HD-MAP expands the platform’s potential applications to a broader spectrum of infectious diseases. This trial addresses a critical need for efficient and accessible vaccination strategies, crucial for mitigating widespread public health crises.
This trial marks the first time Vaxxas is evaluating an adjuvanted vaccine delivered with its HD-MAP. The study compares the safety and immune response of adjuvanted and non-adjuvanted formulations delivered by HD-MAP to traditional needle delivery. Prior Vaxxas clinical trials demonstrated comparable immune responses using significantly less vaccine (one-sixth) without adjuvants compared to traditional methods. If the adjuvanted HD-MAP formulation is safe and effective, it could facilitate a quicker response to future outbreaks.
The results of this trial, anticipated in the first half of 2025, could revolutionize vaccine delivery. Positive outcomes could lead to wider adoption of the HD-MAP technology, not only for pandemic influenza but also for a range of infectious diseases. This shift could significantly improve vaccination accessibility and potentially transform public health responses to future outbreaks.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
