GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free technology, today announced the publication in Nature of the US Army Medical Research Institute of Infectious Diseases (USAMRIID) Phase 1 clinical trial to evaluate the safety and immunogenicity of its plasmid DNA Hantavirus vaccines administered with the Stratis IM System. The study reported that two of the three plasmid DNA vaccines tested are safe and immunogenic in human subjects. Given these positive Phase 1 results the Hantaan and Puumala vaccines delivered with Stratis IM are being included in an ongoing Phase 2a clinical trial.
Rodent-borne hantaviruses, most prevalent in Asia and Europe, cause disease primarily in people working or living in environments where contact with rodents occurs. Individuals become infected when they inhale or ingest materials contaminated with viruses shed from infected animals. Hemorrhagic fever with renal syndrome (HRFS) is caused primarily by infection with Hantaan virus and is a significant health threat in endemic areas, with thousands of hospitalized cases reported each year in China, Europe and Russia. There is no specific vaccine or treatment currently available.
This publication, entitled "Phase 1 clinical trial of Hantaan and Puumala virus DNA vaccines delivered by needle-free injection" was co-authored by representatives of USAMRIID, Walter Reed Army Institute of Research Clinical Trials Center (WRAIR CTC), and PharmaJet. Stratis Needle-free IM injection was used in this study to simplify the delivery and overcome the drawbacks from previous administration methods studied (epidermal delivery with a gene gun and IM-electroporation). This study showed comparable immune response in humans, and in some respects improved immunogenicity over the previous studies with the other 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 .
A review article1 recently published in Vaccines Journal (MDPI) identified that PharmaJet needle-free delivery provides improved tissue distribution and cellular uptake of vaccines. DNA vaccines delivered by needle-free injection also tend to elicit improved, and in some cases significantly superior immune responses compared with needles.
“We are pleased to be collaborating with the USAMRIID to develop vaccines against viral diseases of importance to the Department of Defense,” noted Nathalie Landry, Chief Scientific Officer, PharmaJet. “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.”
For more information visit the PharmaJet website at https://pharmajet.com.
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1 Ledesma-Feliciano, C et al, Improved DNA Vaccine Delivery with Needle-Free Injection Systems, Vaccines 2023, 11(2), 280
About PharmaJet
The PharmaJet mission is to improve the performance and outcomes of injectables with our enabling technology that better activates the immune system. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ can improve vaccine effectiveness and promote a preferred patient and caregiver experience while being safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information or if you are interested in partnering with PharmaJet to improve the impact of your novel development program, visit https://pharmajet.com or contact PharmaJet here. Follow us on LinkedIn.
About the U.S. Army Medical Research Institute of Infectious Diseases
For over 50 years, USAMRIID has provided leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to medical solutions – vaccines, drugs, diagnostics, information, and training programs – that benefit both military personnel and civilians. Established in 1969, the Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency’s Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command. For more information or to collaborate visit https://usamriid.health.mil/ or contact them here. Follow us on Facebook.
