Toxicity assessment of Venezuelan Equine Encephalitis virus vaccine candidate strain V3526

DynPort Vaccine Company (DVC) LLC, a CSC Company, is under a contract with the United States Department of Defense Joint Vaccine Acquisition Program (JVAP) to develop, test and license safe and efficacious vaccines against biowarfare agents. As part of this program DVC is conducting a comprehensive toxicological assessment of the safety of V3526, a live attenuated Venezuelan Equine Encephalitis (VEE) vaccine candidate. Our review of the published pre-clinical toxicology literature, together with the data collected from DVC-sponsored investigations indicated V3526 was comparatively safer and more efficacious than TC-83, the current VEE Investigational New Drug (IND) status vaccine. Non-clinical toxicity studies on experimental systems ranging from mouse, guinea pig, equine and non-human primates (NHP) consistently revealed the V3526 vaccine candidate superior in terms of safety and related toxicological parameters such as neurovirulence when compared with the TC-83. Our experimental investigations indicated that V3526 may conform to the key requirements of a VEE virus vaccine, in that, (a) it elicits a high level of immunogenic response in mice and hamsters, both sensitive to VEE-induced pathologies, and (b) it induces a protective response in the NHP model when challenged with either virulent IA/B or IE viruses. Additional studies are underway to further confirm these findings.