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Lane Clifford
JAIDS Journal of Acquired Immune Deficiency Syndromes: January 2016
doi: 10.1097/01.qai.0000479622.47644.bc
Abstract: PDF Only

In August, 2014, then Liberian Minister of Health Gwenigale sent a letter to HHS Secretary Burwell asking for help from the US in establishing a clinical research program to evaluate experimental approaches to the treatment and prevention of Ebola virus disease. In the subsequent months scientists from the 2 countries worked together to form the Liberian-US Clinical Research Program. The individual elements of clinical research ranging from basic lab support to site monitoring were identified and a Liberian and a US representative assigned to each area. Three protocols have been initiated under this partnership. The first, a randomized, phase II, placebo-controlled trial of the rVSV and ChAd3 vaccine candidates was initiated in February, 2015 and completed enrollment of 1500 subjects in May, 2015. The second, a randomized, controlled, adaptive trial to sequentially test therapeutic candidates was initiated in March and has thus far enrolled approximately 60 subjects in Liberia the US, Sierra Leone and Guinea. The third, an observational study of survivors of Ebola virus disease was initiated in June, 2015 and thus far has enrolled approximately 400 individuals. As part of this work a substantial effort has gone into building both healthcare and clinical research infrastructure with the goal of establishing a sustainable clinical research program in West Africa that will be remain active beyond the current outbreak.

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