title: A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults.
abstract: Two formulations of a new live tetravalent dengue virus (DENV) vaccine produced using re-derived master seeds from a precursor vaccine and that same precursor vaccine as a control were compared in a placebo-controlled, randomized, observer-blind, phase II trial of 86 healthy adults. Two vaccine doses were administered 6 months apart; a third dose was offered to a subset. Symptoms and signs of dengue-like illness reported after vaccination were mild to moderate, transient, and occurred with similar frequency among recipients of the new DENV vaccine and placebo, except for rash. Neither dengue nor vaccine-related serious adverse events were reported. The first DENV vaccine dose was moderately immunogenic; the second dose increased the potency and breadth of the neutralizing antibody response. Tetravalent response rates to the new formulations were 60% and 66.7% in unprimed subjects. A third dose did not increase tetravalent antibody rates. The new DENV vaccine candidates merit additional evaluation.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Thomas
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.forename: Isabelle
authors.initials: I
authors.lastname: Carletti
authors.forename: Rafael
authors.initials: R
authors.lastname: De La Barrera
authors.forename: Francis
authors.initials: F
authors.lastname: Dessy
authors.forename: Stefan
authors.initials: S
authors.lastname: Fernandez
authors.forename: Robert
authors.initials: R
authors.lastname: Putnak
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Toussaint
authors.forename: Wellington
authors.initials: W
authors.lastname: Sun
authors.forename: Kristen
authors.initials: K
authors.lastname: Bauer
authors.forename: Robert V
authors.initials: RV
authors.lastname: Gibbons
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
mesh_terms: D000328:Adult; D053059:Dengue Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D003716:Dengue Virus / Q000276:immunology*; D006801:Humans; D010919:Placebos
chemical_list: D053059:Dengue Vaccines; D010919:Placebos