Closely held PharmaJet has announced that the peer-reviewed journal Nature has published findings from a U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Phase 1 trial, demonstrating that the delivery of a plasmid DNA vaccine for hantaviruses using PharmaJet’s Stratis Needle-Free Intramuscular (IM) System induces the production of a robust and durable immune response.
The trial evaluated the safety and immunogenicity of three plasmid DNA vaccines, with results indicating that two of the three vaccines were both safe and immunogenic in human subjects. Following these positive Phase 1 findings, the Hantaan and Puumala vaccines delivered via the Stratis IM System have been advanced to an ongoing Phase 2a clinical trial.
The publication, co-authored by USAMRIID, Walter Reed Army Institute of Research Clinical Trials Center (WRAIRCTC), and PharmaJet, highlighted the advantages of the Stratis Needle-Free IM injection. The system was used in the study to simplify vaccine delivery and address the limitations of previous administration methods, such as epidermal delivery with a gene gun and IM-electroporation. The study showed that Stratis IM delivered a comparable immune response in humans and, in some cases, improved immunogenicity compared to previous delivery methods.
“We have been looking for a simple and pragmatic method to deliver our DNA vaccines safely and effectively to humans, and this study has shown that PharmaJet’s Stratis needle-free delivery achieved those goals,” said Jay Hooper, deputy division chief of virology, USAMRIID, and lead scientist on the study.
Nathalie Landry, CSO of PharmaJet, noted, “We are pleased to be collaborating with the USAMRIID to develop vaccines against viral diseases of importance to the Department of Defense. The PharmaJet Needle-free Systems have been incorporated into clinical studies across multiple infectious disease development programs and this is another example of how our needle-free technology can match, and often improve, the performance of prophylactic and therapeutic vaccine candidates.”
