title: Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18-25 years: results from a randomized controlled trial.
abstract: This phase II/III, double-blind, randomized trial assessed the efficacy, immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in young Chinese women (ClinicalTrials.gov registration NCT00779766). Women aged 18-25 years from Jiangsu province were randomized (1:1) to receive HPV vaccine (n = 3,026) or Al(OH)3 control (n = 3,025) at months 0, 1 and 6. The primary objective was vaccine efficacy (VE) against HPV-16/18 associated 6-month persistent infection (PI) and/or cervical intraepithelial neoplasia (CIN) 1+. Secondary objectives were VE against virological and clinical endpoints associated with HPV-16/18 and with high-risk HPV types, immunogenicity and safety. Mean follow-up for the according-to-protocol cohort for efficacy (ATP-E) was ∼15 months after the third dose. In the ATP-E (vaccine = 2,889; control = 2,894), for initially HPV DNA negative and seronegative subjects, HPV-16/18 related VE (95% CI) was 94.2% (62.7, 99.9) against 6-month PI and/or CIN1+ and 93.8% (60.2, 99.9) against cytological abnormalities. VE against HPV-16/18 associated CIN1+ and CIN2+ was 100% (-50.4, 100) and 100% (-140.2, 100), respectively (no cases in the vaccine group and 4 CIN1+ and 3 CIN2+ cases in the control group). At Month 7, at least 99.7% of initially seronegative vaccine recipients had seroconverted for HPV-16/18; geometric mean antibody titres (95% CI) were 6,996 (6,212 to 7,880) EU/mL for anti-HPV-16 and 3,309 (2,942 to 3,723) EU/mL for anti-HPV-18. Safety outcomes between groups were generally similar. The HPV-16/18 AS04-adjuvanted vaccine is effective, immunogenic and has a clinically acceptable safety profile in young Chinese women. Prophylactic HPV vaccination has the potential to substantially reduce the burden of cervical cancer in China.
authors.affiliation: Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
authors.forename: Wen
authors.initials: W
authors.lastname: Chen
authors.forename: Yue-Mei
authors.initials: YM
authors.lastname: Hu
authors.forename: Ying
authors.initials: Y
authors.lastname: Hong
authors.forename: Juan
authors.initials: J
authors.lastname: Li
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.forename: Yi-Ju
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Qin-Jing
authors.initials: QJ
authors.lastname: Pan
authors.forename: Fang-Hui
authors.initials: FH
authors.lastname: Zhao
authors.forename: Jia-Xi
authors.initials: JX
authors.lastname: Yu
authors.forename: Yan-Shu
authors.initials: YS
authors.lastname: Zhang
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Yang
authors.forename: Cheng-Fu
authors.initials: CF
authors.lastname: Zhang
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.forename: Helen
authors.initials: H
authors.lastname: Zhang
authors.forename: Marie
authors.initials: M
authors.lastname: Lebacq
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: David
authors.forename: Sanjoy K
authors.initials: SK
authors.lastname: Datta
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
authors.forename: Dan
authors.initials: D
authors.lastname: Bi
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
mesh_terms: D000293:Adolescent; D000328:Adult; D002681:China; D004279:DNA, Viral / Q000235:genetics; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D052162:Human papillomavirus 16 / Q000302:isolation & purification*; D052161:Human papillomavirus 18 / Q000302:isolation & purification*; D006801:Humans; D060787:Neoplasm Grading; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000627:therapeutic use*; D016133:Polymerase Chain Reaction; D016896:Treatment Outcome; D002578:Uterine Cervical Dysplasia / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D053918:Papillomavirus Vaccines
keywords: China; efficacy; human papillomavirus vaccine; immunogenicity; safety
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