PharmaJet®, the maker of innovative, needle-free injection technology, today announced the reporting of positive interim results from the Phase 1 clinical trial conducted by the US Army Medical Research Institute of Infectious Diseases (USAMRIID). The clinical trial is evaluating two hantavirus vaccines to prevent hemorrhagic fever with renal syndrome (HFRS), using the PharmaJet Stratis® needle-free injection system. Hantaan virus (HTNV) causes the most severe form of HFRS, which has a 5 to 15 percent fatality rate and affects tens of thousands of people annually. Currently no vaccine is available.1
PharmaJet’s delivery device was chosen for this Phase 1 trial after pre-clinical studies with similar vaccines showed significantly higher (tenfold increase) immunogenicity with the needle-free device, as compared to needle and syringe, and comparable results to electroporation.2 “The interim immunogenicity results in the Phase 1 trial look promising, and the PharmaJet needle-free device has an excellent safety profile in humans,” said Jay W. Hooper, Ph.D., Chief, Molecular Virology Branch, Virology Division, USAMRIID. “An added benefit of the needle-free injector is that it eliminates needles completely from the process of administering vaccines, as well as the costs and dangers associated with sharp-needle waste.”
Comments by Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc.: “We are pleased with the interim results from the Phase 1 clinical trial for a hantavirus vaccine that has the potential to save lives.” He concluded, “Our needle-free devices are continuing to help novel DNA technologies move successfully from pre-clinical studies into early and late stage clinical trials.”
Data on file. Refer to Instructions for Use to ensure safe injections and to review risks.
1 J.W. Hooper, et al, DNA Vaccination with Hantaan Virus M Gene Protects Hamsters against Three of Four HFRS Hantaviruses and Elicits a High-Titer Neutralizing Antibody Responses in Rhesus Monkey, Journal of Virology, September 2001, p.8469 0 8477
2 Steve Kwilas et al, A Hantavirus Pulmonary Syndrome (HPS) DNA Vaccine Delivered Using a Spring-powered Jet Injector Elicits a Potent Neutralizing Antibody Response in Rabbits and Nonhuman Primates, Current Gene Therapy, May 2014, 14, 200-210