American Journal of Tropical Medicine and Hygiene
July 2014; 91 (1)
http://www.ajtmh.org/content/current

Safety and Immunogenicity of a Rederived, Live-Attenuated Dengue Virus Vaccine in Healthy Adults Living in Thailand: A Randomized Trial
Veerachai Watanaveeradej, Robert V. Gibbons, Sriluck Simasathien, Ananda Nisalak, Richard G. Jarman, Angkool Kerdpanich, Elodie Tournay, Rafael De La Barrerra, Francis Dessy, Jean-François Toussaint, Kenneth H. Eckels, Stephen J. Thomas, and Bruce L. Innis
Am J Trop Med Hyg 2014 91:119-128; Published online May 27, 2014, doi:10.4269/ajtmh.13-0452
Abstract.
Safety and immunogenicity of two formulations of a live-attenuated tetravalent dengue virus (TDEN) vaccine produced using rederived master seeds from a precursor vaccine were tested against a placebo control in a phase II, randomized, double blind trial (NCT00370682). Two doses were administered 6 months apart to 120 healthy, predominantly flavivirus-primed adults (87.5% and 97.5% in the two vaccine groups and 92.5% in the placebo group). Symptoms and signs reported after vaccination were mild to moderate and transient. There were no vaccine-related serious adverse events or dengue cases reported. Asymptomatic, low-level viremia (dengue virus type 2 [DENV-2], DENV-3, or DENV-4) was detected in 5 of 80 vaccine recipients. One placebo recipient developed a subclinical natural DENV-1 infection. All flavivirus-unprimed subjects and at least 97.1% of flavivirus-primed subjects were seropositive to antibodies against all four DENV types 1 and 3 months post-TDEN dose 2. The TDEN vaccine was immunogenic with an acceptable safety profile in flavivirus-primed adults.
Disclaimer: E.T., F.D., J.-F.T., and B.L.I. are employees of the GlaxoSmithKline (GSK) group of companies (GSK). F.D., J.-F.T., and B.L.I. own shares and options to shares in GSK. All other authors report no conflict of interest. The opinions or assertions contained herein are the private views of the authors and are not to be construed as reflecting the official views of the US Army, the US Department of Defense, or the Royal Thai Army.