Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial.

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Title: Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial.
Authors: Zhao FH; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Wu T; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Hu YM; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China., Wei LH; Peking University People's Hospital, Beijing, China., Li MQ; Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China., Huang WJ; National Institute for Food and Drug Control, Beijing, China., Chen W; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Huang SJ; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Pan QJ; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Zhang X; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Hong Y; the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China., Zhao C; Peking University People's Hospital, Beijing, China., Li Q; Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, Guangdong, China., Chu K; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China., Jiang YF; the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China., Li MZ; Peking University People's Hospital, Beijing, China., Tang J; Funing Center for Disease Control and Prevention, Funing, Jiangsu, China., Li CH; Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China., Guo DP; Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China., Ke LD; Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China., Wu X; Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China., Yao XM; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China., Nie JH; National Institute for Food and Drug Control, Beijing, China., Lin BZ; Xiamen Innovax Biotech Xiamen, Fujian, China., Zhao YQ; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Guo M; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China., Zhao J; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China., Zheng FZ; Xiamen Innovax Biotech Xiamen, Fujian, China., Xu XQ; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Su YY; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Zhang QF; Xiamen Innovax Biotech Xiamen, Fujian, China., Sun G; Xiamen Innovax Biotech Xiamen, Fujian, China., Zhu FC; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China., Li SW; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Li YM; Beijing Wantai Biological Pharmacy Enterprise, Beijing, China., Pan HR; Xiamen Innovax Biotech Xiamen, Fujian, China., Zhang J; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China. Electronic address: zhangj@xmu.edu.cn., Qiao YL; School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China., Xia NS; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China; Research Unit of Frontier Technology of Structural Vaccinology of Chinese Academy of Medical Sciences, China.
Source: The Lancet. Infectious diseases [Lancet Infect Dis] 2022 Dec; Vol. 22 (12), pp. 1756-1768. Date of Electronic Publication: 2022 Aug 26.
Publication Type: Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Elsevier Science Country of Publication: United States NLM ID: 101130150 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-4457 (Electronic) Linking ISSN: 14733099 NLM ISO Abbreviation: Lancet Infect Dis Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1474-4457
DOI:10.1016/S1473-3099(22)00435-2