biostudies-literatureUnknown26(1)Shi L<h4>Background</h4>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.<h4>Methods</h4>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 (aBMC infectious diseases248https://www.ebi.ac.uk/biostudies/studies/S-EPMC12870096biostudies-literatureEfficacy, 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.PMC12870096Yan-Hua XieXue-Mei YanShi LDong-Zhang YangLing-Yun ZhouHuang LYan-Ping LiKe LiJiang-Bing ZhengZhen HuangYu-Liang ZhaoMin JiFan HJing-Jing ChenZi-Long WangYong-Biao RenLi ShiQiang LuWei LiMo ZWang YRong-Cheng LiLi GLi JWei-Jiang CuiLi CHPV1003 Study groupYuan LNian-Min ShiLi QShi-Fang WenBin HeZhan-Bo GengHai-Song ZhouYu BGao ZGao XGuo-Gang LiuYa-Lin HuYan-Xia CaifalseEfficacy, 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.<h4>Background</h4>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.<h4>Methods</h4>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 (a2025-01-01T00:00:00Z2025 Dec2026-07-15T06:11:25.124Z2026-06-30T03:16:16.783ZS-EPMC128700964141345310.1186/s12879-025-12064-1