BioCentury
ARTICLE | Clinical News

NIH planning Phase I Ebola vaccine trial

August 2, 2014 1:12 AM UTC

NIH plans to start a Phase I trial in September to evaluate an Ebola virus vaccine, with data expected by January 2015. The plans come in the wake of a worsening outbreak of Ebola in West Africa. According to the World Health Organization, at least 729 deaths this year have been attributed to the virus, including 57 deaths reported July 24-27. NIH said it hopes to give the vaccine to health workers in affected African countries "as early as 2015" if it proves safe and effective. The vaccine -- a non-replicating chimpanzee adenovirus vector containing two Ebola genes -- was designed by researchers at the Vaccine Research Center at NIH's National Institute of Allergy and Infectious Diseases.

News of the increased severity of the outbreak sent the stock price of Tekmira Pharmaceuticals Corp. (TSX:TKM; NASDAQ:TKMR), which has an Ebola therapy in the clinic, up $1.45 (11%) to $14.26 on NASDAQ and up C$1.57 (11%) to C$15.55 in Toronto on Friday. Last month, FDA placed a full clinical hold on a Phase I trial evaluating the company's TKM-Ebola on safety concerns. The company is preparing its response to FDA and anticipates resolution by 4Q14. The product is a combination of short interfering RNAs (siRNAs) targeting Zaire Ebola L polymerase, Zaire Ebola membrane-associated protein ( VP24) and Zaire Ebola polymerase complex protein ( VP35) formulated with Tekmira's lipid nanoparticle (LNP) technology. ...