The Department of Defense (DoD), through the Medical Countermeasure Systems-Joint Vaccine Acquisition Program (MCS-JVAP), has contracted the manufacture and IND-enabling preclinical testing of the Profectus trivalent Ebola/Marburg vaccine. Profectus BioSciences is a Baltimore, Md.-based clinical-stage vaccine company developing novel vaccines for the treatment and prevention of infectious diseases.
John Eldridge, Ph.D., chief scientific officer of Profectus, said, "More than 15 years have been invested in developing the genetically attenuated rVSVN4CT1 VesiculoVax vaccine delivery platform and demonstrating its safety in multiple clinical trials. To date, it is the only vaccine to demonstrate single-dose protection of monkeys against lethal challenge with highly virulent low-passage Ebola and Marburg viruses."
The contract can be extended to a total of 13 months and $8.6 million. Profectus will apply to the FDA for an Investigational New Drug (IND) designation that would allow initiation of human clinical trials of the vaccine's safety and immunogenicity in humans.
This most recent contract award for $9.5 million from the JVAP through Battelle, which contracted with Profectus for manufacturing and clinical evaluation and with Charles River Laboratories and Biologics Consulting Group for preclinical testing and IND preparation, respectively, will support manufacture of the trivalent rVSVN4CT-vectored Ebola/Marburg vaccine, and phase I clinical evaluation of rVSVN4CT1-Zaire-Ebola virus vaccine for safety and immunogenicity. A rapid follow up trial of the trivalent vaccine is being planned.