title: Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus-naive infants.
abstract: A Phase I/II observer-blind, randomized, controlled trial evaluated the safety and immunogenicity of a dengue virus (DENV) vaccine candidate in healthy Thai infants (aged 12-15 months) without measurable pre-vaccination neutralizing antibodies to DENV and Japanese encephalitis virus. Fifty-one subjects received two doses of either DENV (N = 34; four received 1/10th dose) or control vaccine (N = 17; dose 1, live varicella; dose 2, Haemophilus influenzae type b). After each vaccine dose, adverse events (AEs) were solicited for 21 days, and non-serious AEs were solicited for 30 days; serious AEs (SAEs) were recorded throughout the study. Laboratory safety assessments were performed at 10 and 30 days; neutralizing antibodies were measured at 30 days. The DENV vaccine was well-tolerated without any related SAEs. After the second dose, 85.7% of full-dose DENV vaccinees developed at least trivalent and 53.6% developed tetravalent neutralizing antibodies ≥ 1:10 to DENV (control group = 0%). This vaccine candidate, therefore, warrants continued development in this age group (NCT00322049; clinicaltrials.gov).
authors.affiliation: Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. veerachaiw@yahoo.com
authors.forename: Veerachai
authors.initials: V
authors.lastname: Watanaveeradej
authors.forename: Sriluck
authors.initials: S
authors.lastname: Simasathien
authors.forename: Ananda
authors.initials: A
authors.lastname: Nisalak
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Endy
authors.forename: Richard G
authors.initials: RG
authors.lastname: Jarman
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Thomas
authors.forename: Robert V
authors.initials: RV
authors.lastname: Gibbons
authors.forename: Sumetha
authors.initials: S
authors.lastname: Hengprasert
authors.forename: Rudiwilai
authors.initials: R
authors.lastname: Samakoses
authors.forename: Angkool
authors.initials: A
authors.lastname: Kerdpanich
authors.forename: David W
authors.initials: DW
authors.lastname: Vaughn
authors.forename: J Robert
authors.initials: JR
authors.lastname: Putnak
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.forename: Rafael De La
authors.initials: Rde L
authors.lastname: Barrera
authors.forename: Mammen P
authors.initials: MP
authors.lastname: Mammen
mesh_terms: D003715:Dengue / Q000517:prevention & control*; D053059:Dengue Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D004672:Encephalitis, Japanese / Q000517:prevention & control; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D022321:Japanese Encephalitis Vaccines / Q000276:immunology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D053059:Dengue Vaccines; D022321:Japanese Encephalitis Vaccines; D014613:Vaccines, Attenuated