title: Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial.
abstract: Safety and immunogenicity of two formulations of a live-attenuated tetravalent dengue virus (TDEN) vaccine produced using rederived master seeds from a precursor vaccine were tested against a placebo control in a phase II, randomized, double blind trial (NCT00370682). Two doses were administered 6 months apart to 120 healthy, predominantly flavivirus-primed adults (87.5% and 97.5% in the two vaccine groups and 92.5% in the placebo group). Symptoms and signs reported after vaccination were mild to moderate and transient. There were no vaccine-related serious adverse events or dengue cases reported. Asymptomatic, low-level viremia (dengue virus type 2 [DENV-2], DENV-3, or DENV-4) was detected in 5 of 80 vaccine recipients. One placebo recipient developed a subclinical natural DENV-1 infection. All flavivirus-unprimed subjects and at least 97.1% of flavivirus-primed subjects were seropositive to antibodies against all four DENV types 1 and 3 months post-TDEN dose 2. The TDEN vaccine was immunogenic with an acceptable safety profile in flavivirus-primed adults.
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Veerachai
authors.initials: V
authors.lastname: Watanaveeradej
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Robert V
authors.initials: RV
authors.lastname: Gibbons
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Sriluck
authors.initials: S
authors.lastname: Simasathien
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Ananda
authors.initials: A
authors.lastname: Nisalak
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Jarman
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Angkool
authors.initials: A
authors.lastname: Kerdpanich
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Elodie
authors.initials: E
authors.lastname: Tournay
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Rafael
authors.initials: R
authors.lastname: De La Barrerra
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Francis
authors.initials: F
authors.lastname: Dessy
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Toussaint
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania stephen.j.thomas3.mil@mail.mil.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Thomas
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis* / Q000097:blood; D003715:Dengue / Q000097:blood / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D053059:Dengue Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D003716:Dengue Virus / Q000145:classification / Q000276:immunology*; D005260:Female; D006801:Humans; D056724:Immunity, Humoral / Q000187:drug effects*; D007115:Immunization Schedule; D008297:Male; D058889:Molecular Typing; D010919:Placebos; D013785:Thailand; D014611:Vaccination; D014613:Vaccines, Attenuated
chemical_list: D000914:Antibodies, Viral; D053059:Dengue Vaccines; D010919:Placebos; D014613:Vaccines, Attenuated