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 |
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| Authors: | Feng‐Cai Zhu Wen Chen Yue‐Mei Hu Ying Hong Juan Li Xun Zhang Yi‐Ju Zhang Qin‐Jing Pan Fang‐Hui Zhao Jia‐Xi Yu Yan‐Shu Zhang Xiaoping Yang Cheng‐Fu Zhang Haiwen Tang Helen Zhang Marie Lebacq Marie‐Pierre David Sanjoy K Datta Frank Struyf Dan Bi Dominique Descamps for the HPV‐ study group |
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| Affiliation: | 1. Jiangsu Province Center for Disease Prevention and Control, Nanjing, China;2. Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS) and Peking Union Medical College, Beijing, China;3. The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu province, China;4. National Institutes for Food and Drug Control, Beijing, China;5. Xuzhou Center for Disease Prevention and Control, Xuzhou, Jiangsu Province, China;6. Binhai Center for Disease Prevention and Control, Binhai, Jiangsu Province, China;7. Jintan Center for Disease Prevention and Control, Jintan, Jiangsu Province, China;8. Lianshui Center for Disease Prevention and Control, Lianshui, Jiangsu Province, China;9. GlaxoSmithKline Vaccines, Shanghai, China;10. GlaxoSmithKline, Beijing, China;11. GlaxoSmithKline Vaccines, Wavre, Belgium |
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| 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. |
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| Keywords: | human papillomavirus vaccine China efficacy safety immunogenicity |
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