Profectus BioSciences Initiates Ebola Vaccine Phase 1 Clinical Trial
Tuesday, January 19, 2016
Profectus BioSciences, Inc., a clinical-stage vaccine company developing novel vaccines for the prevention and treatment of infectious diseases and the treatment of cancer, announced today the initiation of a Phase 1 clinical study of Profectus' VesiculoVax™-vectored Ebola virus vaccine. 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 Africa1.
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 trial is designed to establish the safety and immunogenicity of the vaccine at dose levels that span the dose shown to protect monkeys.
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).
"Profectus is pleased to announce initiation of the first step in a systematic clinical evaluation of our filovirus vaccine," said John H. Eldridge, PhD, Chief Scientific Officer of Profectus. "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. That will be followed by the testing of a freeze-dried formulation that will allow field use without refrigerated storage. We want to acknowledge the continuing financial and technical support provided by MCS-JVAP and especially for providing the funding for the execution of this Phase 1 clinical trial."