On February 2, the Liberia-U.S. Joint Clinical Research Partnership initiated a large Ebola vaccine trial in West Africa. The randomized controlled trial in Monrovia, Liberia, strives to determine if administration of a single dose of an experimental vaccine will protect against Ebola. The two vaccines are the ChAd3-EBOZ vaccine, manufactured by GlaxoSmithKline, and the rVSV-ZEBOV vaccine, manufactured by Merck/NewLink.
The U. S. National Institutes of Health (NIH) is sponsoring the trial and University of Minnesota School of Public Health faculty members are working closely with NIH and Liberian scientists to provide biostatistical leadership and data management support.
Over the past three months, School of Public Health faculty and staff from Biostatistics and Epidemiology & Community Health have worked under the leadership of Biostatistics Professor James Neaton with colleagues from NIH, Liberia and the participating pharmaceutical companies to develop a trial protocol. That work included many trips to Liberia to identify vaccination centers and establish the necessary trial infrastructure.
“It is an honor for my colleagues at the University of Minnesota and me to collaborate on this large-scale undertaking to prevent infection by this deadly virus,” said Neaton, who has led some of the world’s largest HIV treatment trials. “So many people have spent time in Monrovia and many more on the home front have worked hard to get this trial up and running.”
The trial is part of a study called PREVAIL (Partnership for Research on Ebola Vaccines in Liberia), which comes as the result of a request from the Liberian Minister of Health to the U.S. Secretary of the Department of Health and Human Services to enter into a partnership on clinical research. The intended purpose of this collaboration is to accelerate the development of vaccines to prevent Ebola and medicines to treat people infected with the disease.
For the trial, approximately 27,000 healthy adult volunteers will be divided into three groups and each participant will be injected with one of the two vaccines or a saline (saltwater) placebo solution. Each group will have about 9,000 people.
The assignment of a volunteer to a specific vaccine group will be determined by chance and all participants will be given advice on how to avoid being infected with Ebola.
Neither the volunteer nor the study staff will know which vaccine has been administered until the end of the study. The first volunteer was vaccinated today at Monrovia’s Redemption Hospital. Several additional sites in Liberia are planned.