title: Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18.
abstract: Human papillomavirus (HPV) infection causes cervical cancer and genital warts. Young women (1106) were randomized to receive one of three formulations of a quadrivalent HPV (Types 6/11/16/18) L1 virus-like particle (VLP) vaccine or one of two placebo formulations. The goal was to assess vaccine safety and immunogenicity in baseline HPV 6/11/16 or 18-naïve and previously infected subjects. All three formulations were highly immunogenic. At Month 2 (postdose 1), among women with vaccine-type antibodies at baseline, vaccine-induced anti-HPV responses were approximately 12- to 26-fold higher than those observed in baseline-naïve women, suggesting an anamnestic response. Following an initial, similar sized decline, anti-HPV responses plateaued and remained stable through end-of-study (3.0 years). No vaccine-related serious adverse experiences were reported.
authors.affiliation: Department of Virology, Ludwig Institute for Cancer Research, R. Prof. Antonio Prudente 109, 4th floor, 01509-010 Sao Paulo, SP, Brazil. llvilla@ludwig.org.br
authors.forename: Luisa L
authors.initials: LL
authors.lastname: Villa
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Ault
authors.forename: Anna R
authors.initials: AR
authors.lastname: Giuliano
authors.forename: Ronaldo L R
authors.initials: RL
authors.lastname: Costa
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Petta
authors.forename: Rosires P
authors.initials: RP
authors.lastname: Andrade
authors.forename: Darron R
authors.initials: DR
authors.lastname: Brown
authors.forename: Alex
authors.initials: A
authors.lastname: Ferenczy
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.forename: Laura A
authors.initials: LA
authors.lastname: Koutsky
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Kurman
authors.forename: Matti
authors.initials: M
authors.lastname: Lehtinen
authors.forename: Christian
authors.initials: C
authors.lastname: Malm
authors.forename: Sven-Eric
authors.initials: SE
authors.lastname: Olsson
authors.forename: Brigitte M
authors.initials: BM
authors.lastname: Ronnett
authors.forename: Finn Egil
authors.initials: FE
authors.lastname: Skjeldestad
authors.forename: Margareta
authors.initials: M
authors.lastname: Steinwall
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.forename: Cosette M
authors.initials: CM
authors.lastname: Wheeler
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Taddeo
authors.forename: Jimmy
authors.initials: J
authors.lastname: Yu
authors.forename: Lisa
authors.initials: L
authors.lastname: Lupinacci
authors.forename: Radha
authors.initials: R
authors.lastname: Railkar
authors.forename: Rocio
authors.initials: R
authors.lastname: Marchese
authors.forename: Mark T
authors.initials: MT
authors.lastname: Esser
authors.forename: Janine
authors.initials: J
authors.lastname: Bryan
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.forename: Heather L
authors.initials: HL
authors.lastname: Sings
authors.forename: Gretchen M
authors.initials: GM
authors.lastname: Tamms
authors.forename: Alfred J
authors.initials: AJ
authors.lastname: Saah
authors.forename: Eliav
authors.initials: E
authors.lastname: Barr
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D052140:Human papillomavirus 11 / Q000276:immunology; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D052163:Human papillomavirus 6 / Q000276:immunology; D006801:Humans; D027383:Papillomaviridae / Q000145:classification / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology / Q000821:virology; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines