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' VesiculoVaxTM-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."
About Profectus VesiculoVaxTM Vaccines
Profectus has developed the highly immunogenic VesiculoVaxTM vaccine delivery system for emerging infectious disease indications where the rapid induction of neutralizing antibodies is needed to protect against the viruses that cause hemorrhagic fevers such as Ebola, Marburg, and Lassa; encephalitic disease (VEE, EEE, WEE); and arthralgic disease (Chikungunya). The Profectus VesiculoVaxTM vaccine delivery technology is based on seminal discoveries made in the laboratory of Dr. John Rose and patented by Yale University. Building on these discoveries, Profectus scientists introduced multiple non-reversible genetic modifications into the prototype that synergistically attenuate the virus and provide vectors that are safe for human use. To extend the VesiculoVaxTM platform, Profectus is conducting collaborative studies with scientists at the University of Texas Medical Branch (UTMB) that have identified additional vesiculoviruses with utility as vaccine vectors. The resulting VesiculoVaxTM platform consists of a family of non-cross reactive vaccine vectors that are constructed and attenuated so they do not cause illness in animal or humans using methods exemplified with rVSV. Profectus has demonstrated the safety and immunogenicity of its VesiculoVaxTM rVSV-based vaccines against HIV in human clinical trials.