TY - JOUR
T1 - 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
AU - Bauer, Kristen
AU - Esquilin, Ines O.
AU - Cornier, Alberto Santiago
AU - Thomas, Stephen J.
AU - Del Rio, Ana I.Quintero
AU - Bertran-Pasarell, Jorge
AU - Ramirez, Javier O.Morales
AU - Diaz, Clemente
AU - Carlo, Simon
AU - Eckels, Kenneth H.
AU - Tournay, Elodie
AU - Toussaint, Jean Francois
AU - De La Barrera, Rafael
AU - Fernandez, Stefan
AU - Lyons, Arthur
AU - Sun, Wellington
AU - Innis, Bruce L.
N1 - Publisher Copyright:
Copyright © 2015 by The American Society of Tropical Medicine and Hygiene.
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/84941635771
U2 - 10.4269/ajtmh.14-0625
DO - 10.4269/ajtmh.14-0625
M3 - Article
C2 - 26175027
AN - SCOPUS:84941635771
SN - 0002-9637
VL - 93
SP - 441
EP - 453
JO - American Journal of Tropical Medicine and Hygiene
JF - American Journal of Tropical Medicine and Hygiene
IS - 3
ER -