title: Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years.
abstract: Immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine were evaluated in healthy Chinese females aged 9-45 years in 2 phase IIIB, randomized, controlled trials. Girls aged 9-17 years (ClinicalTrials.gov, NCT00996125) received vaccine (n = 374) or control (n = 376) and women aged 26-45 years (NCT01277042) received vaccine (n = 606) or control (n = 606) at months 0, 1, and 6. The primary objective was to show non-inferiority of anti-HPV-16 and -18 immune responses in initially seronegative subjects at month 7, compared with Chinese women aged 18-25 years enrolled in a separate phase II/III trial (NCT00779766). Secondary objectives were to describe the anti-HPV-16 and -18 immune response, reactogenicity and safety. At month 7, immune responses were non-inferior for girls (9-17 years) vs. young women (18-25 years): the upper limit of the 95% confidence interval (CI) for the geometric mean titer (GMT) ratio (women/girls) was below the limit of 2 for both anti-HPV-16 (0.37 [95% CI: 0.32, 0.43]) and anti-HPV-18 (0.42 [0.36, 0.49]). Immune responses at month 7 were also non-inferior for 26-45 year-old women vs. 18-25 year-old women: the upper limit of the 95% CI for the difference in seroconversion (18-25 minus 26-45) was below the limit of 5% for both anti-HPV-16 (0.00% [-1.53, 1.10]) and anti-HPV-18 (0.21% [-1.36, 1.68]). GMTs were 2- to 3-fold higher in girls (9-17 years) as compared with young women (18-25 years). The HPV-16/18 AS04-adjuvanted vaccine had an acceptable safety profile when administered to healthy Chinese females aged 9-45 years.
authors.affiliation: a Center for Disease Prevention and Control; Nanjing City, Jiangsu Province, PR China.
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
authors.forename: Juan
authors.initials: J
authors.lastname: Li
authors.forename: Yuemei
authors.initials: Y
authors.lastname: Hu
authors.forename: Xiang
authors.initials: X
authors.lastname: Zhang
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Yang
authors.forename: Hui
authors.initials: H
authors.lastname: Zhao
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
authors.forename: Jianguo
authors.initials: J
authors.lastname: Yang
authors.forename: Guodong
authors.initials: G
authors.lastname: Xia
authors.forename: Qinyong
authors.initials: Q
authors.lastname: Dai
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.forename: Pemmaraju
authors.initials: P
authors.lastname: Suryakiran
authors.forename: Sanjoy K
authors.initials: SK
authors.lastname: Datta
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.forename: Dan
authors.initials: D
authors.lastname: Bi
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
mesh_terms: D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage* / Q000009:adverse effects*; D000914:Antibodies, Viral / Q000097:blood; D044466:Asian People; D002648:Child; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D064368:Healthy Volunteers; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D006801:Humans; D008050:Lipid A / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D016896:Treatment Outcome; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000276:immunology / Q000517:prevention & control*
chemical_list: C532963:ASO4 mixture; D000914:Antibodies, Viral; D008050:Lipid A; D053918:Papillomavirus Vaccines; D000536:Aluminum Hydroxide
keywords: China; HPV-16/18 AS04-adjuvanted vaccine; cervical cancer; female; human papillomavirus; immunogenicity; safety