Tuesday, October 28, 2014

Swiss test GSK Ebola vaccine in some volunteers going to Africa

GENEVA (Reuters) - Switzerland's drug regulator said on Tuesday it had approved the testing of an experimental Ebola vaccine from GlaxoSmithKline on healthy volunteers, some of whom will be traveling to West Africa as medical staff.

The trial will be conducted among 120 volunteer participants at the Lausanne University Hospital, with support from the World Health Organization.

The volunteers, who include many medical students, will be monitored for six months to determine both the safety and efficacy of the vaccine. There is a small control group of volunteers among them who will be given a placebo.

"Fifty front-line humanitarian workers going into the field will receive the vaccine. The other 70 are not being deployed and of those 20 will receive the placebo and 50 the vaccine," said hospital spokesman Darcy Christen.

"Volunteers going into the field will not receive the placebo, for ethical reasons."

There are currently no proven drugs or vaccines for Ebola but drugmakers, with backing from governments and donors, hope to produce millions of vaccine doses in 2015 by fast-tracking the normal lengthy development process.

GSK has estimated it might be able to make about 1 million doses of its vaccine a month by December 2015.

The GSK vaccine, which is already undergoing safety tests in Britain, the United States and Mali, is one of two leading vaccine candidates now in early human testing.

The University Hospital of Geneva is to test the other vaccine from NewLink Genetics on a similar number of volunteers, after vials of that vaccine arrived in Geneva last week.

Results from these and other early trials will provide the basis for planning larger studies, involving thousands of participants, and for choosing vaccine dose-level for such efficacy trials.