Phase II Ebola Vaccine Trials Delayed By African Regulators

Phase II trials of a much-lauded Ebola vaccine have been pushed back until at least the second week of February, after African regulators asked GlaxoSmithKline for more information about the upcoming studies.

Officials from eight African countries, including those hardest hit by the disease, met recently to discuss GKS’s Phase II application and seek more details on the protocols of the trial. If GSK provides the requested information, officials are expected to decide on whether GSK may proceed by the end of January, the World Health Organization said last week.

GSK had hoped to start the trials this month. Phase I trials that began this fall indicate that the vaccine is safe and effective, with Ebola antibodies and T cells produced by all 20 healthy volunteers. — Lena Freund