title: Overview of the benefits and potential issues of the nonavalent HPV vaccine.
abstract: HPV-related diseases affect anogenital and oropharyngeal regions, heavily affecting the psychosexual dimension of both male and female individuals. HPV vaccination programs based on a bivalent or quadrivalent vaccine have opened broad perspectives for primary prevention. A nonavalent HPV vaccine (9vHPV), covering nine genotypes (HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58), might provide further improvement in terms of direct protection. In the present report, efficacy and safety data from 9vHPV vaccine development programs are examined. Efficacy data come from a pivotal trial, which was conducted among women aged 16-26 years randomly assigned to receive either the 9vHPV or the quadrivalent HPV (4vHPV) vaccine. The 9vHPV vaccine was shown to have potential benefits as compared with 4vHPV, increasing the overall estimated rate of prevention to 90% for cervical cancer and up to 80% for precancerous cervical lesions. For all other HPV-related pre-invasive and invasive lesions, 9vHPV showed potentially greater disease reduction, depending on the anatomic region examined. Thus, the 9vHPV vaccine shows clinical potential for the prevention of HPV-related diseases in both sexes. Future adoption of 9vHPV will depend on factors including market price, cost-effectiveness data, use of a two-dose schedule, and safety and efficacy monitoring in real-life programs.
authors.affiliation: Regina Elena National Cancer Institute, HPV-Unit, Gynecologic Oncology, Rome, Italy.
authors.forename: Luciano
authors.initials: L
authors.lastname: Mariani
authors.affiliation: Department of Obstetrics and Gynecology, University of Torino, Turin, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Preti
authors.affiliation: Villa Montallegro, Genoa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Cristoforoni
authors.affiliation: Unità Ospedaliera Complessa Ginecologia Preventiva, Azienda Sanitaria Provinciale di Cosenza, Castrovillari, Italy.
authors.forename: Carlo M
authors.initials: CM
authors.lastname: Stigliano
authors.affiliation: Obstetrics and Gynecology, Ospedali Riuniti Villa Sofia Cervello, University of Palermo, Palermo, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Perino
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000145:classification / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control* / Q000821:virology
chemical_list: D053918:Papillomavirus Vaccines
keywords: 
  HPV
  ; Cervical cancer; HPV nonavalent vaccine; Prevention