• Kristen Bauer, Ines O Esquilin, Alberto Santiago Cornier, Stephen J Thomas, Ana I Quintero Del Rio, Jorge Bertran-Pasarell, Javier O Morales Ramirez, Clemente Diaz, Simon Carlo, Kenneth H Eckels, Elodie Tournay, Jean-Francois Toussaint, Rafael De La Barrera, Stefan Fernandez, Arthur Lyons, Wellington Sun, and Bruce L Innis.
• Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Department of Molecular Medicine, La Concepcion Hospital, San German, Puerto Rico; Department of Biochemistry, Ponce School of Medicine, Ponce, Puerto Rico; Centro de Reumatologia Pediatrica de Puerto Rico, San Juan, Puerto Rico; Clinical Research Puerto Rico, Inc., San Juan, Puerto Rico; Department of Molecular Medicine, La Concepcion Hospital, San German, Puerto Rico; Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, Maryland; GSK Vaccines, Wavre, Belgium; GSK Vaccines, King of Prussia, Pennsylvania.
• Am. J. Trop. Med. Hyg. 2015 Sep 1; 93 (3): 441-53.

AbstractThis was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1-50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2-4 years], 60% [5-20 years], and 93% [21-50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858.© The American Society of Tropical Medicine and Hygiene.

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