FDAnews Drug Daily Bulletin

Ebola Vaccines Will Enter Phase III Soon

April 3, 2015

Two Ebola vaccines are set to enter Phase III testing in West Africa soon.

While there is not an official start date, the National Institute of Allergy and Infectious Diseases says talks to take the trial from Liberia to neighboring countries that have more than one active Ebola case are ongoing.

A trial in Guinea or Sierra Leone would aim to enroll 27,000 patients, a spokesperson said.

Patients will be randomized to receive either a chimp adenovirus-carried vaccine developed by the NIAID and GlaxoSmithKline, or another developed by the Public Health Agency of Canada and licensed to NewLink Genetics and Merck.

Both vaccines proved safe in earlier tests. Phase I testing that began late last year at Oxford University revealed acceptable safety and immunogenicity. Patients were randomized to receive one of the vaccines or a placebo, with the NIH announcing initial positive results in January.

Investigators will continue enrolling patients in Phase II through April primarily to increase the number of women participating in the trial, officials said. Those patients will be followed for one year. — Lena Freund