October 13, 2014
By Mark Terry, BioSpace.com Breaking News Staff
GlaxoSmithKline in conjunction with the U.S.-based Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID) has begun administering its experimental Ebola vaccine to healthcare providers in Mali. So far three health staff have received the vaccine, with 37 more expected to be given it in the upcoming weeks.
“This research will give us crucial information about whether the vaccine is safe, well tolerated and capable of stimulating adequate immune responses in the highest priority target population, healthcare workers in West Africa,” said the University of Maryland Center for Vaccine Development (CVD) director Myron Levine in a statement. “If it works, in the foreseeable future it could help alter the dynamic of this epidemic by interrupting transmission to healthcare and other exposed front-line workers.”
Similar Phase 1 trials are planned in Gambia. The first part of the trials began in September in Oxford, England, and involves 60 volunteers. Studies in Mali and Gambia each have 40 individuals participating. If the trials are successful, which are designed to evaluate differences in safety and immune responses, the World Health Organization (WHO) expects to begin small-scale use of the GSK vaccine, as well as another vaccine in development by NewLink Genetics.
NewLink Genetics, based in Ames, Iowa, recently announced the FDA had give the company permission to enter Phase 1 trials with its Ebola vaccine candidate. The vaccine was first developed by the Public Health Agency of Canada (PHAC), and is part of an exclusive licensing agreement with BioProtection Systems, a subsidiary of NewLink. They are working with the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) and the Walter Reed Army Institute of Research (WRAIR) for the Phase 1 trial.
GSK expects data from the US and UK trials by November. This will provide information that will help pave the way for possible Phase 3 trials. In addition, with funds provided by the UK’s Wellcome Trust and other organizations, GSK is ramping up production of the vaccine to manufacture 10,000 doses. That way, if the trials are positive, they can immediately start vaccinating healthcare workers in the affected countries.
Mali, to date, has no known cases of Ebola, but the African country borders Guinea, the site of the current outbreak’s origins. “It’s purely a scientific step,” said Ousmane Kone, Mali’s health minister in a recent statement. “The trials are on volunteer researchers.”
