A phase II, randomized, safety and immunogenicity trial of a re-derived, live-attenuated dengue virus vaccine in healthy children and adults living in puerto rico

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, Bruce L. Innis

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

Abstract

This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, liveattenuated, 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.

Original languageEnglish
Pages (from-to)441-453
Number of pages13
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume93
Issue number3
DOIs
StatePublished - 1 Sep 2015
Externally publishedYes

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