title: Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls.
abstract: A 9-valent human papillomavirus (HPV 6/11/16/18/31/33/45/52/58) virus-like particle vaccine (9vHPV) has been proven highly efficacious in preventing anogenital diseases related to HPV, in a pivotal phase III study for women aged 16-26 years. Here, we report the results of an open-label phase III study conducted to bridge the gap between the findings in women aged 16-26 years and Japanese girls aged 9-15 years. All subjects (n = 100) received a 3-dose regimen of 9vHPV vaccine on day 1 and at months 2 and 6. Anti-HPV serological assays were performed on day 1 and at months 7, 12, 24, and 30. At month 7 (4 weeks after the third dose), 100% of the subjects exhibited seroconversion for each type of HPV. Increases in geometric mean of the titers for anti-HPV 6/11/16/18/31/33/45/52/58 in the subjects were similar to those in Japanese women aged 16-26 years in a previous phase III study. Persistence of the anti-HPV response was observed for 2 years after administration of the third dose. In addition, administration of the 9vHPV vaccine was generally well-tolerated in Japanese girls.
authors.affiliation: Keio University School of Medicine.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iwata
authors.affiliation: MSD KK.
authors.forename: Shinya
authors.initials: S
authors.lastname: Murata
authors.affiliation: MSD KK.
authors.forename: Shi
authors.initials: S
authors.lastname: Rong Han
authors.affiliation: MSD KK.
authors.forename: Akira
authors.initials: A
authors.lastname: Wakana
authors.affiliation: MSD KK.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Sawata
authors.affiliation: MSD KK.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D044466:Asian People; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D027383:Papillomaviridae / Q000276:immunology*; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013997:Time Factors; D058425:Vaccines, Virus-Like Particle / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D058425:Vaccines, Virus-Like Particle
keywords: HPV; Japan; human papillomavirus; immunogenicity; safety