The race against time

The first time Dr Ripley Ballou, Vice President of GlaxoSmithKline (GSK) Biologicals, contacted the World Health Organization (WHO) about a promising Ebola vaccine candidate, it was 24 March 2014--the day WHO issued news of the Ebola virus disease outbreak in Guinea. "I was told that since there were no human data, there were no policies or pathways for its use in the current outbreak," Ballou recalls. "There was also a strong belief that the usual approach of containments would stop the outbreak." When WHO called Ballou a few months later the picture had changed, and on 8 August WHO declared the outbreak a public health emergency of international concern. "We realized this outbreak was different and the approach used successfully in previous outbreaks--detecting and isolating cases, identifying contacts and safely burying the deceased--was not working," says Dr Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. Within a month, Kieny and her team hosted a gathering of more than 200 of the world's leading vaccine experts from industry, academia and regulatory authorities as well as public health officials from the countries affected and experts in filo-viruses and viral haemorrhagic diseases. The 4-5 September meeting reviewed the pipeline of therapies and vaccines for Ebola and whether it was feasible to test them in time to help stop the outbreak in the worst affected countries: Guinea, Liberia and Sierra Leone. [ILLUSTRATION OMITTED] "We identified two promising vaccine candidates which we agreed should be tested as quickly as possible without compromising safety and scientific rigour," says Kieny, a microbiologist, who worked in vaccine and cancer research in France for 20 years before joining WHO in 2001 to establish the WHO Initiative for Vaccine Research. Since then, Kieny has overseen the development and licensing of new vaccines for meningitis and pandemic influenza in developing countries, by pioneering the transfer of technology and know-how. Now, she is devoting much of her time to galvanizing international collaborations to speed up the pipeline for Ebola vaccines and therapies. "Usually it takes five to 10 years to research and develop a new vaccine--we foresee doing this within a year or 18 months--which is unprecedented," Kieny says. For Ballou, there is no question of cutting corners. "We're pressing the system as hard as we can. Things that take 2 or 3 months, are getting done in a fraction of that time." One of the vaccine candidates is a recombinant chimpanzee adenovirus expressing an Ebola virus protein or ChAd3, that was developed by GSK and the US National Institute of Allergy and Infectious Diseases (NIAID). In one study, researchers found that a single dose of ChAd3 protected all 16 animals given a lethal dose of the Ebola virus. The other vaccine--a recombinant vesicular stomatitis virus (rVSV) expressing an Ebola virus protein, developed by the Public Health Agency of Canada and US-based NewLink Pharmaceuticals--protected all 20 animals given a lethal dose of the virus. Newlink recently licensed the technology to Merck, which is taking responsibility for the future development of the vaccine. A third vaccine developed by Johnson & Johnson is due to be tested in Phase 1 clinical trials starting this month. In addition, five US-based companies, Profectus Biosciences, Protein Sciences, Novavax, Vaxart and Inovio, are each developing their own vaccine candidates, while three further candidates are being developed in the Russian Federation and other European countries. Phase 1 trials to test the safety of the GSK-NIAID vaccine started in the United Kingdom and United States in September and continued in Mali and Switzerland in October--aiming to enrol 260 participants. Phase 1 trials of rVSV started in the United States in October and Gabon, Germany, Kenya and Switzerland in November with 250 participants. …