Seattle’s Access to Advanced Health Institute (AAHI) has been awarded a project agreement worth up to $9.9 million by the US government to develop a prototype intranasal bivalent influenza RNA vaccine candidate.

The vaccine will target pandemic A(H5N1) and A(H7N9) influenza virus pathogens. The 40-month project may culminate in a vaccine candidate that is effective against both strains of influenza, according to a press release by AAHI.

AAHI’s RNA platform, which delivers self-amplifying RNA bound to the exterior of a nanostructured lipid carrier, entered first-in-human clinical trials in May 2022 with phase 1/2 clinical trials of the “AAHI-SC2” COVID-19 vaccine candidate.

Current mRNA vaccines against COVID-19 reduce severe illness and hospitalization, but they require boosters to maintain protection, are not always effective against viral variants, and do not effectively curtail viral transmission. Although influenza vaccines have been available for almost a century, three influenza pandemics have occurred since the 1918 H1N1 pandemic, of which the most recent 2009 pandemic claimed hundreds of thousands of lives worldwide in the first year.

Through this award, AAHI will build on its initial research and development of an intranasal pandemic influenza RNA vaccine candidate in liquid and dry powder presentations. Intranasal vaccine administration could reduce or eliminate the use of needles by the ease of self-administration, potentially increasing vaccine uptake, and by driving key mucosal immune responses not typically induced by needle-administered vaccines.

Preclinical studies supporting the feasibility of AAHI’s intranasal RNA vaccine showed that AAHI’s self-amplifying RNA vaccine construct against COVID-19 induced robust lung-resident T-cell immunity, coupled with strong systemic immunity. These results were presented on Nov. 8, 2022, at the 10th International mRNA Health Conference in Boston. The findings demonstrated that AAHI’s intranasal COVID-19 RNA vaccine provides an immune stimulatory combination that is key for robust protection and may also help significantly limit viral transmission.

“Stimulating robust systemic and mucosal immunity with rapid-response RNA vaccine technology would be a game-changer for pandemic preparedness,” says Emily Voigt, PhD, principal scientist, AAHI RNA platform lead, and principal investigator for the award, in a press release. “Our preliminary data show great promise in preclinical models but have a long way to go to demonstrate effectiveness in humans. This prototype project is designed to bridge that gap quickly and effectively.”

The prototype project was awarded on behalf of the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense and the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services.

Photo: AAHI’s GMP manufacturing suite (Business Wire)