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Ef?cacy, immunogenicity and safety of the HPV-16/18 AS04- adjuvanted vaccine in healthy Chinese women aged 18C25 years: Results from a randomized controlled trial Feng-cai Zhu1 , Wen Chen2 , Yue-Mei Hu1 , Ying Hong3 , Juan Li4 , Xun Zhang2 , Yi-Ju Zhang1 , Qin-Jing Pan2 , Fang-Hui Zhao2 , Jia-Xi Yu5 , Yan-Shu Zhang6 , Xiaoping Yang7 , Cheng-Fu Zhang8 , Haiwen Tang9 , Helen Zhang10 , Marie Lebacq11 , Marie-Pierre David11 , Sanjoy K Datta11 , Frank Struyf11 , Dan Bi11 , Dominique Descamps11 , for the HPV-039 study group

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 Key words: human papillomavirus vaccine, China, ef?cacy, safety, immunogenicity Abbreviations: AGC: atypical glandular cells;

ASC-H: atypical squamous cells cannot exclude high-grade squamous intraepithelial lesions;

ASC-US1: atypical squamous cells of undetermined significance or higher;

ASC-US: atypical squamous cells of undetermined significance;

ATP-E: according-to-protocol cohort for efficacy;

CDC: Center for Disease Control and Prevention;

CI: confidence interval;

CICAMS: Cancer Institute and Hospital, Chinese Academy of Medical Sciences;

CIN: cervical intraepithelial neoplasia;

ELISA: enzyme- linked immunosorbent assay;

EU: ELISA units;

GMT: geometric mean antibody titre;

HPV: human papillomavirus;

HSIL: high-grade squamous intraepithelial lesions;

LSIL: low-grade squamous intraepithelial lesions;

MPL: 3-O-desacyl-40 -monophosphoryl lipid A;

PCR: polymerase chain reaction;

PI: persistent infection;

SAE: serious adverse event;

SD: standard deviation;

TVC-E: total vaccinated cohort for efficacy;

TVC: total vaccinated cohort;

VE: vaccine efficacy This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modi?cations or adaptations are made Additional Supporting Information may be found in the online version of this article.

Contributors: Other authors from the HPV-039 study group who have contributed to the study and the review and approval of the article: Yong Chen, Yejiang Zhu (Binhai CDC). Shang-ying Hu, Feng Chen, Bin Liu, Jian-feng Cui, Xin-fu Liu, Unench Sharnuud and Wen-hua Zhang (CICAMS). Xiao-Li Cui (Shenyang Fourth People'

s Hospital, Shenyang city, Liaoning Province). Hongxing Pan (Jiangsu Province CDC). Haihua Le, Changrong Wang (Jintan CDC). Shiyin Xue, Jiahong Zhu (Lianshui CDC). Yong Chen, Ling Ling Shen (Xuzhou CDC). Con?ict of Interest: All authors have completed the Uni?ed Competing Interest form at http://www.icmje.org/coi_disclosure.pdf and declare that their respective institutions received clinical trial funding from the GlaxoSmithKline group of companies, through the Jiangsu Province CDC, the CICAMS (Beijing, China) and the National Institutes for Food and Drug Control (NIFDC) (Beijing, China). F. Zhu, F. Zhao, Y. Hu received support for travel to meetings related to the study from the GlaxoSmithKline group of companies. H. Tang, H. Zhang, M. Leb- acq, M.-P. David, S. Datta, F. Struyf, D. Bi and D. Descamps are employees of the GlaxoSmithKline group of companies. H. Tang, M.-P. David, S. Datta, F. Struyf, D. Bi and D. Descamps hold restricted shares and/or stock options from the GlaxoSmithKline group of companies. Grant sponsor: This work was supported by GlaxoSmithKline Vaccines (registered as GlaxoSmithKline Biologicals SA). GlaxoSmithKline Vaccines designed the study in collaboration with investigators and coordinated gathering, analysis and interpretation of data and writing of the report. Investigators from the HPV-039 study group gathered data for the trial and cared for the women. All authors had full access to the complete ?nal study report and had ?nal responsibility for the decision to submit for publication. The manuscript was developed and coordinated by the authors in collaboration with an independent medical writer and a publication manager, both working on behalf of Glax- oSmithKline Vaccines. DOI: 10.1002/ijc.28897 History: Received