The cooperative R&D agreement (CRADA) is for a two-year study that will utilize the Biojector 2000 in human subjects.
An additional objective is to promote a partnering relationship between the Naval Medical Research Center and Bioject Medical Technologies in order to facilitate the free flow of information for use in the preparation and approval of an investigational new drug application with the FDA in which the use of the Biojector as a delivery device for malaria vaccines is proposed.
Richard Stout, chief medical officer of Bioject, said: “The overall objective of this research agreement is the evaluation of the Biojector needle-free jet injection system as a delivery device for a malaria vaccine in Phase I human clinical trials. We are excited to show through this research agreement the performance levels achievable using the Biojector to deliver malaria vaccines as compared to use of a needle delivery method.”