title: 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.
abstract: This 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.
authors.forename: Kristen
authors.initials: K
authors.lastname: Bauer
authors.forename: Ines O
authors.initials: IO
authors.lastname: Esquilin
authors.forename: Alberto Santiago
authors.initials: AS
authors.lastname: Cornier
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Thomas
authors.forename: Ana I
authors.initials: AI
authors.lastname: Quintero Del Rio
authors.forename: Jorge
authors.initials: J
authors.lastname: Bertran-Pasarell
authors.forename: Javier O
authors.initials: JO
authors.lastname: Morales Ramirez
authors.forename: Clemente
authors.initials: C
authors.lastname: Diaz
authors.forename: Simon
authors.initials: S
authors.lastname: Carlo
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.forename: Elodie
authors.initials: E
authors.lastname: Tournay
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Toussaint
authors.forename: Rafael
authors.initials: R
authors.lastname: De La Barrera
authors.forename: Stefan
authors.initials: S
authors.lastname: Fernandez
authors.forename: Arthur
authors.initials: A
authors.lastname: Lyons
authors.forename: Wellington
authors.initials: W
authors.lastname: Sun
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
mesh_terms: D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003715:Dengue / Q000276:immunology / Q000517:prevention & control*; D053059:Dengue Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D003716:Dengue Virus / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011647:Puerto Rico / Q000453:epidemiology; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D053059:Dengue Vaccines; D014613:Vaccines, Attenuated