A new clinical study of Profectus’ VesiculoVax-vectored Ebola virus vaccine has begun, looking to establish the safety and immunogenicity of the vaccine in human volunteers.
The Phase 1, placebo-controlled, dose-escalation study will enroll 39 subjects into three groups that will receive progressively higher doses of the vaccine by intramuscular injection.
The vaccine is a version of the company’s patented VSV vector that has been engineered for safe use in humans and to express the surface protein of Ebola virus. In preclinical studies, a single dose of this vaccine completely protected monkeys against the strain of Ebola virus responsible for the recent outbreak in West Africa.
The Profectus Ebola vaccine programs are supported by the U.S. Department of Defense Medical Countermeasures Systems–Joint Vaccine Acquisition Program (MCS-JVAP) both directly and through contracts with Battelle, the Biomedical Advanced Research and Development Authority (BARDA), and the National Institutes of Health (NIH).
“This first study is designed to quickly establish the safety and immunogenicity of our attenuated VSV-vectored Ebola vaccine. The next step, anticipated for mid-next year, will be a trial of our trivalent vaccine to protect against all species of Ebola and Marburg viruses,” said John H. Eldridge, PhD, Chief Scientific Officer of Profectus.
Looking forward, Profectus intends to conduct advanced development of a freeze-dried formulation that will allow field use without refrigerated storage.