title: Human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for the prevention of cervical cancer and HPV-related diseases.
abstract: Vaccines are available against human papillomavirus (HPV), the causal agent of cervical and other cancers. Efficacy data from the HPV-16/18 AS04-adjuvanted vaccine clinical trial program were reviewed. Six randomized, controlled phase II/III trials evaluating cervical endpoints enrolled women from diverse populations and geographical locations. The program analyzed extensively the cohorts most relevant from a public health perspective: the total vaccinated cohort (TVC), approximating a general population including those with existing or previous HPV infection, and TVC-naïve, approximating a population of young women before sexual debut. Results show that the vaccine reduces HPV-16/18 infection and associated cervical endpoints in women regardless of age, location, or sexual experience. It provides cross-protection against some non-vaccine oncogenic HPV types and types causing genital warts, and may be effective against vulvar, oral, and anal HPV infection. Early epidemiology data following its introduction suggest a decline in the prevalence of vaccine and some non-vaccine HPV types.
authors.affiliation: a Sydney University Discipline of Paediatrics and Child Health , The Children's Hospital at Westmead , Sydney , NSW , Australia.|b Vaccine Trials Group, Telethon Kids Institute , University of Western Australia , Perth , Australia.
authors.forename: S Rachel
authors.initials: SR
authors.lastname: Skinner
authors.affiliation: c Family Federation of Finland , Sexual Health Clinic , Helsinki , Finland.
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
authors.affiliation: d Department of Gynecology and Obstetrics, Gynecology and Obstetrics Infectious Diseases Sector , University of Parana , Curitiba , Parana , Brazil.
authors.forename: Newton
authors.initials: N
authors.lastname: De Carvalho
authors.affiliation: e Department of Obstetrics and Gynecology, Geisel School of Medicine at Dartmouth , Hanover , NH , USA.|f Department of Family and Geriatric Medicine, University of Louisville School of Medicine , Louisville , KY , USA.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.affiliation: g Department of Obstetrics and Gynaecology , Jichi Medical University Saitama Medical Center , Saitama , Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Konno
authors.affiliation: h Department of Obstetrics and Gynaecology , University of Helsinki , Helsinki , Finland.
authors.forename: Jorma
authors.initials: J
authors.lastname: Paavonen
authors.affiliation: i Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry , University of Alberta , Edmonton , AB , Canada.
authors.forename: Barbara
authors.initials: B
authors.lastname: Romanowski
authors.affiliation: j Leonor M de Barros Hospital , São Paulo , Brazil.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Roteli-Martins
authors.affiliation: k GSK Vaccines , Wavre , Belgium.
authors.forename: Nansa
authors.initials: N
authors.lastname: Burlet
authors.affiliation: k GSK Vaccines , Wavre , Belgium.
authors.forename: Attila
authors.initials: A
authors.lastname: Mihalyi
authors.affiliation: k GSK Vaccines , Wavre , Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000536:Aluminum Hydroxide / Q000008:administration & dosage*; D001005:Anus Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003218:Condylomata Acuminata / Q000453:epidemiology / Q000517:prevention & control; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D008050:Lipid A / Q000008:administration & dosage / Q000031:analogs & derivatives*; D009062:Mouth Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D030361:Papillomavirus Infections / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D016032:Randomized Controlled Trials as Topic; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*
chemical_list: C532963:ASO4 mixture; D000276:Adjuvants, Immunologic; D008050:Lipid A; D053918:Papillomavirus Vaccines; D000536:Aluminum Hydroxide
keywords: Cervical cancer; HPV; efficacy; human papillomavirus; literature review; randomized controlled trial; vaccination