title: Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children.
abstract: We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1-4 waned during the 1-3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response.
authors.forename: Veerachai
authors.initials: V
authors.lastname: Watanaveeradej
authors.forename: Sriluck
authors.initials: S
authors.lastname: Simasathien
authors.forename: Mammen P
authors.initials: MP
authors.lastname: Mammen
authors.forename: Ananda
authors.initials: A
authors.lastname: Nisalak
authors.forename: Elodie
authors.initials: E
authors.lastname: Tournay
authors.forename: Phirangkul
authors.initials: P
authors.lastname: Kerdpanich
authors.forename: Rudiwilai
authors.initials: R
authors.lastname: Samakoses
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Putnak
authors.forename: Robert V
authors.initials: RV
authors.lastname: Gibbons
authors.forename: In-Kyu
authors.initials: IK
authors.lastname: Yoon
authors.forename: Richard G
authors.initials: RG
authors.lastname: Jarman
authors.forename: Rafael
authors.initials: R
authors.lastname: De La Barrera
authors.forename: Philippe
authors.initials: P
authors.lastname: Moris
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Eckels
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Thomas
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
mesh_terms: D000914:Antibodies, Viral / Q000096:biosynthesis / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003715:Dengue / Q000453:epidemiology / Q000517:prevention & control*; D053059:Dengue Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000592:standards*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D013785:Thailand / Q000453:epidemiology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology / Q000592:standards
chemical_list: D000914:Antibodies, Viral; D053059:Dengue Vaccines; D014613:Vaccines, Attenuated