FDA [to 26 March 2016]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

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Posted: 3/22/2016
FDA Scientists Contribute to Development of Investigational Dengue Vaccine
On March 16, 2016, the National Institutes of Health announced that an investigational dengue vaccine developed at the National Institute for Allergy and Infectious Disease (NIAID) has advanced into a phase 3 efficacy trial in Brazil. Lew Markoff, MD, and Barry Falgout, PhD, with the Laboratory of Vector-borne Virus Diseases in FDA’s Center for Biologics Evaluation and Research, made an early contribution to the development of this vaccine. The phase 3 trial is a direct result of success in a human challenge study where the vaccine protected healthy U.S volunteers from signs and symptoms of dengue. The study involved a total of 41 individuals, 21 of whom received the vaccine and 20 of whom received a placebo on the same day. After six months, all volunteers were infected with a strain of dengue virus chosen because it causes only mild manifestations of disease. All of the vaccine recipients were protected, while all 20 volunteers who received placebo experienced a rash and/or other mild manifestations of dengue fever, caused by the challenge dengue virus…