Essential medicines and health products

Phase II clinical trial application for ChAd3 Ebola vaccine reviewed by national regulators

During a meeting convened by WHO on 15-16 December 2014, representatives from African national regulatory authorities and ethics committees reviewed an application for Phase II clinical trials of the chimpanzee adenovirus serotype-3 (ChAd3) Ebola vaccine.

The two-day review provided a forum for a thorough discussion on all aspects of the proposed trials. Reviewing countries requested additional documentation from the manufacturer of the vaccine, GlaxoSmithKline, before authorization of the trials. The submission of additional information, and subsequent review by the countries planning to host the trials, is expected to take place by the end of January. If these steps are completed to the satisfaction of the national authorities, Phase II trials are likely to begin in February.

Regulatory and ethics officials from the countries where the Phase II trials were being considered (Cameroon, Ghana, Mali, Nigeria and Senegal) were present, as well as from the countries most affected by the ongoing Ebola outbreak (Guinea, Liberia and Sierra Leone, as observers).