GOLDEN, Colo., Dec. 5, 2017 /PRNewswire/ -- PharmaJet® Inc., the maker of needle-free injection technology, announced today that the first ever human clinical study of an mRNA rabies vaccine successfully showed immunogenicity when administered with their needle-free injection devices.
The study, published in the September issue of The Lancet1 is the first demonstration in humans that a prophylactic mRNA-based vaccine (RNActive®), developed by CureVac AG can induce boostable functional antibodies against a viral antigen. A key finding was that the use of needle-free injection demonstrated successful immunogenicity of the vaccine, while needle-syringe failed to induce an adequate antibody response.
Messenger RNA (mRNA) can be harnessed to carry data to instruct the human body to produce customized proteins as medicine to fight diseases. mRNA vaccines offer added advantages in that they are easily developed, inexpensive to produce, and efficiently scalable for manufacturing purposes.2
Rabies is a vaccine-preventable viral disease that occurs in more than 150 countries and territories. Approximately 55,000 people die annually, many of them children.3 "We are encouraged by the results of the CureVac clinical trial and the immunogenicity benefit that was provided by our PharmaJet needle-free Injectors," said Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc. "This is one of many recent examples where PharmaJet devices are helping nucleic acid based technologies translate their success in the pre-clinical stage into successful clinical studies"
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1 Safety and immunogenicity of a mRNA rabies vaccine in healthy adults;: an open-label, non-randomized, prospective, first-in-human phase 1 clinical trial, Alberer et al., The Lancet, Volume 390, No. 10101, p. 1511-1520, 23 September 2017;
2 Enabling the Body to Manufacture it's Own Medicine: The Power and Potential of mRNA, Hoerr, I., Genetic Engineering News, November 1, 2016
3 World Health Organization Rabies Fact Sheet, September, 2017
PharmaJet's mission is worldwide acceptance of PharmaJet needle-free devices as a standard of care in the vaccine delivery market. The Stratis® device has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver vaccines either intramuscularly or subcutaneously. In August 2014, this device was cleared for delivery of an influenza vaccine to deliver needle-free flu shots. The Tropis® device for intradermal injections received authorization to apply the CE Mark in May 2016. www.pharmajet.com.
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