title: Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial.
abstract: An Escherichia coli-expressed recombinant bivalent human papillomavirus (types 16 and 18) vaccine candidate has been shown to be safe and immunogenic in preclinical trials. The safety of this vaccine was analyzed in an open-label phase I clinical trial in Jiangsu province, China. Thirty-eight healthy women from 18 to 55 y of age were enrolled and vaccinated at 0, 1, and 6 mo. Adverse events that occurred within 30 d after each injection and serious adverse events that occurred throughout the study were recorded. In addition, blood parameters were tested before and after each injection. All but one woman received all 3 doses. Thirty-two (84.2%) of the participants reported adverse events, all adverse events of which were mild, of short duration and resolved spontaneously. No serious adverse events occurred during the study. Changes in blood parameters after each injection were random, mild, and not clinically significant. These preliminary results show that a new Escherichia coli-expressed recombinant HPV 16/18 bivalent vaccine is well tolerated in healthy women and support further immunogenicity and efficacy studies for this HPV vaccine candidate.
authors.affiliation: Jiangsu Provincial Center for Disease Control and Prevention; Nanjing, Jiangsu Province, PR China.
authors.forename: Yue-Mei
authors.initials: YM
authors.lastname: Hu
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases; School of Public Health; Xiamen University; Xiamen, PR China.
authors.forename: Shou-Jie
authors.initials: SJ
authors.lastname: Huang
authors.affiliation: Jiangsu Provincial Center for Disease Control and Prevention; Nanjing, Jiangsu Province, PR China.
authors.forename: Kai
authors.initials: K
authors.lastname: Chu
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases; School of Public Health; Xiamen University; Xiamen, PR China.
authors.forename: Ting
authors.initials: T
authors.lastname: Wu
authors.affiliation: Dongtai Center for Disease Control and Prevention; Dongtai, Jiangsu Province, PR China.
authors.forename: Zhong-Ze
authors.initials: ZZ
authors.lastname: Wang
authors.affiliation: Dongtai Center for Disease Control and Prevention; Dongtai, Jiangsu Province, PR China.
authors.forename: Chang-Lin
authors.initials: CL
authors.lastname: Yang
authors.affiliation: Dongtai Center for Disease Control and Prevention; Dongtai, Jiangsu Province, PR China.
authors.forename: Jia-Ping
authors.initials: JP
authors.lastname: Cai
authors.affiliation: Dongtai Center for Disease Control and Prevention; Dongtai, Jiangsu Province, PR China.
authors.forename: Han-Min
authors.initials: HM
authors.lastname: Jiang
authors.affiliation: Dongtai Center for Disease Control and Prevention; Dongtai, Jiangsu Province, PR China.
authors.forename: Yi-Jun
authors.initials: YJ
authors.lastname: Wang
authors.affiliation: Xiamen Innovax Biotech Company, Ltd.; Xiamen, PR China.
authors.forename: Meng
authors.initials: M
authors.lastname: Guo
authors.affiliation: Xiamen Innovax Biotech Company, Ltd.; Xiamen, PR China.
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Liu
authors.affiliation: Xiamen Innovax Biotech Company, Ltd.; Xiamen, PR China.
authors.forename: Hong-Jiang
authors.initials: HJ
authors.lastname: Huang
authors.affiliation: Jiangsu Provincial Center for Disease Control and Prevention; Nanjing, Jiangsu Province, PR China.
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases; School of Public Health; Xiamen University; Xiamen, PR China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases; School of Public Health; Xiamen University; Xiamen, PR China.
authors.forename: Ning-Shao
authors.initials: NS
authors.lastname: Xia
mesh_terms: D000293:Adolescent; D000328:Adult; D036022:Capsid Proteins / Q000235:genetics / Q000276:immunology*; D002681:China; D004337:Drug Carriers; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004926:Escherichia coli / Q000235:genetics*; D005260:Female; D005822:Genetic Vectors; D006801:Humans; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000235:genetics / Q000276:immunology*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D058425:Vaccines, Virus-Like Particle / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*; D055815:Young Adult
chemical_list: D036022:Capsid Proteins; D004337:Drug Carriers; D009856:Oncogene Proteins, Viral; D053918:Papillomavirus Vaccines; D014614:Vaccines, Synthetic; D058425:Vaccines, Virus-Like Particle; C063317:L1 protein, Human papillomavirus type 16; C480565:L1 protein, Human papillomavirus type 18
keywords: clinical trial; human papillomavirus; phase I; safety; vaccine