Leaked documents reveal behind-the-scenes Ebola vaccine issues

Extensive background documents from a meeting that took place today at the World Health Organization (WHO) have provided new details about exactly what it will take to test, produce, and bankroll Ebola vaccines, which could be a potential game changer in the epidemic.

ScienceInsider obtained materials that vaccinemakers, governments, and WHO provided to the 100 or so participants at a meeting on “access and financing” of Ebola vaccines. The documents put hard numbers on what until now have been somewhat fuzzy academic discussions. And they make clear to the attendees—who include representatives from governments, industry, philanthropies, and nongovernmental organizations—that although testing and production are moving forward at record speed, knotty issues remain.

At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might scale up production in parallel with the safety and efficacy trials now under way so that the product could be ready for wider distribution by April if warranted. The company expects to have preliminary data in November from phase I studies that analyze safety and immune response in small numbers of people not at risk of contracting Ebola. If those data are positive, efficacy trials could start as early as January in Guinea, Sierra Leone, and Liberia, the three West African countries hard hit by the epidemic.

Earlier discussions suggested that efficacy trials should recruit health care workers and first-line responders like those who do burials or track contacts of known infected people. WHO estimates that there are about 12,000 health care workers in the three affected countries and another 17,500 “community” responders.

GSK is considering two efficacy trials. The largest would take place in Liberia and involve 12,000 people. This study, which could begin in mid-January, would randomize half of the participants to receive the vaccine and the other half a placebo. The study could also have a third arm, GSK said: A vaccine made by NewLink Genetics of Ames, Iowa, that has just entered phase I studies in the United States. The U.S. National Institutes of Health indicated that it was interested in leading this study.

A second trial would start simultaneously in Sierra Leone, Ripley Ballou, who is heading the GSK Ebola vaccine project, told ScienceInsider. “One of the trials may fail for logistics reasons,” he explained. “We only have one shot to get this right.” The trial in Sierra Leone would not use a placebo but instead would offer groups of health care workers the vaccine at different points in time. This “stepped-wedge” trial could involve up to 8000 people, and the U.S. Centers for Disease Control and Prevention has had preliminary discussions with affected countries about staging these studies. Although Guinea is also hard hit, it has the least infrastructure in place to do a trial, Ballou says. “It would be the most challenging place to do a phase III study.”

GSK estimates (see table below, and here) that it will have 24,000 doses of its vaccine ready by January for the efficacy trials. If it cranks up production to full capacity before the those trials are complete, the company could have 230,000 doses available in April, and then could steadily increase capacity to produce more than 1 million doses a month by December 2015.

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Dan Mullin is an active writer and editor for the Pluto Daily who covered the 2014 Ebola Outbreak. Mullin attended the Wake Forest School of Medicine before leaving to pursue his lifelong science goal of allowing humans to live forever via a computer/brain transfer.