{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["26(1)"],"submitter":["Shi L"],"pubmed_abstract":["Background
Affordable HPV vaccines are needed to accelerate elimination of cervical cancer. We evaluated the efficacy, safety, and immunogenicity of a recombinant bivalent human papillomavirus (HPV) vaccine composed of L1 virus-like particles (VLPs) for HPV 16 and HPV18 (HPV-2), produced in Pichia pastoris, in healthy Chinese women aged 18-30 years.Methods
In this phase 3, double-blind, randomised, placebo-controlled trial conducted at 10 centres in China (Nov 2014-Jan 2020), participants were assigned 1:1 to receive three doses of HPV-2 or placebo at months 0, 2, and 6. The primary endpoint was efficacy against histopathology-confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with HPV16/18 through 48 months. Secondary endpoints were safety (a"],"journal":["BMC infectious diseases"],"pagination":["248"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12870096"],"repository":["biostudies-literature"],"pubmed_title":["Efficacy, safety and immunogenicity of a recombinant human papillomavirus bivalent (types 16, 18) vaccine in healthy 18-30-year-old Chinese women: a phase III, double-blind, randomized, controlled trial."],"pmcid":["PMC12870096"],"pubmed_authors":["Yan-Hua Xie","Xue-Mei Yan","Shi L","Dong-Zhang Yang","Ling-Yun Zhou","Huang L","Yan-Ping Li","Ke Li","Jiang-Bing Zheng","Zhen Huang","Yu-Liang Zhao","Min Ji","Fan H","Jing-Jing Chen","Zi-Long Wang","Yong-Biao Ren","Li Shi","Qiang Lu","Wei Li","Mo Z","Wang Y","Rong-Cheng Li","Li G","Li J","Wei-Jiang Cui","Li C","HPV1003 Study group","Yuan L","Nian-Min Shi","Li Q","Shi-Fang Wen","Bin He","Zhan-Bo Geng","Hai-Song Zhou","Yu B","Gao Z","Gao X","Guo-Gang Liu","Ya-Lin Hu","Yan-Xia Cai"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy, safety and immunogenicity of a recombinant human papillomavirus bivalent (types 16, 18) vaccine in healthy 18-30-year-old Chinese women: a phase III, double-blind, randomized, controlled trial.","description":"Background
Affordable HPV vaccines are needed to accelerate elimination of cervical cancer. We evaluated the efficacy, safety, and immunogenicity of a recombinant bivalent human papillomavirus (HPV) vaccine composed of L1 virus-like particles (VLPs) for HPV 16 and HPV18 (HPV-2), produced in Pichia pastoris, in healthy Chinese women aged 18-30 years.Methods
In this phase 3, double-blind, randomised, placebo-controlled trial conducted at 10 centres in China (Nov 2014-Jan 2020), participants were assigned 1:1 to receive three doses of HPV-2 or placebo at months 0, 2, and 6. The primary endpoint was efficacy against histopathology-confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with HPV16/18 through 48 months. Secondary endpoints were safety (a","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Dec","modification":"2026-07-15T06:11:25.124Z","creation":"2026-06-30T03:16:16.783Z"},"accession":"S-EPMC12870096","cross_references":{"pubmed":["41413453"],"doi":["10.1186/s12879-025-12064-1"]}}