HHS efforts to develop a vaccine to prevent Ebola is moving forward with support from the Office of the Assistant Secretary for Preparedness and Response (ASPR) www.phe.gov. The Biomedical Advanced Research and Development Authority (BARDA) within ASPR is providing $5.8 million to develop an experimental Ebola vaccine.
BARDA will contract for one year with Profectus BioSciences Inc. in Baltimore www.profectusbiosciences.net. The company will manufacture vaccine for use in animal safety studies, do future clinical trials, and conduct animal studies to test safety. The contract can be extended to 13 months with $8.6 million in funding.
Upon successful completion of this work, the company expects to submit an investigational new drug application to FDA. This application if accepted by FDA would allow the vaccine to begin the first clinical trials for safety in humans.
The project builds on early research on this experimental vaccine supported by the National Institute of Allergy and Infectious Diseases (NAID)www.niaid.nih.gov along with animal studies supported by DOD. In the DOD-supported studies, a single dose of the experimental Ebola vaccine provided 100 percent protection in non-human primates.
NIAID is currently supporting Phase 1 clinical trials examining an investigational Ebola vaccine developed by GlaxoSmithKline www.gsk.com and an experimental Ebola vaccine developed by the Public Health Agency of Canada www.phac-aspc.gc.ca/index-eng.php and licensed to NewLink Genetics Corp http://newlinkgenetics.com. Phase 2 clinical efficacy trials for these vaccine candidates are expected in 2015.
BARDA is also exploring how their Centers for Innovation in Advanced Development and Manufacturing www.medicalcountermeasures.gov/hhscentersforinnovation.aspx can accelerate the manufacturing time for Ebola therapeutics and vaccines.