According to information from MRC, the vaccine is being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline.
Professor Umberto D’Alessandro, director of MRC Unit, The Gambia, who is a principal investigator of the trial said: “Thanks to the long term collaboration between the UK’s MRC and the Gambian Government’s Ministry of Health, the unit has the proven capacity and expertise to carry out trials to the highest quality standards including trials for vaccines similar to this one. The proposed trial won’t benefit immediately those currently at risk but we hope that in a not too distant future we may be able to protect people against Ebola.”
According to a statement issued by the MRC, the aim of the safety trials will be to make sure that the vaccine does not cause unexpected side effects and generates a good immune response against Ebola virus in humans. “The vaccine is against the species of Ebola which is circulating in West Africa. It cannot cause a person who is vaccinated to become infected with Ebola because it does not contain infectious virus material.
“A team led by the University of Oxford, will start the safety tests. If tests in the first healthy volunteers in Oxford show the vaccine is safe and result in a good immune response, the trial will, after approval from the relevant authorities, be extended to healthy volunteers at the MRC Unit in The Gambia. The Oxford study will involve 60 volunteers and those in The Gambia and Mali will each involve 40. Each set of volunteers will be split into groups of 20 that will receive different doses of the vaccine so researchers can evaluate the best dose to use in terms of both safety and immunity. This vaccine trial will not establish protective efficacy against Ebola Viral Disease.
“The West African arms will ensure that the studies take account of differences between European and West African populations that might affect safety or immune response. The multi-trial approach will help ensure the fastest possible progress to determining the best candidate vaccine approach and delivery. If the phase 1 trials are finished by the end of 2014, use of the vaccine could be fast tracked if it proves to be safe and immunogenic.”
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