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
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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 (adverse events [AEs] within 1 month of any dose; serious AEs throughout follow-up) and immunogenicity (neutralising antibody titres and seroconversion at Month 7 in a predefined subset). RESULTS: Of 12,000 women enrolled, 11,999 received the first dose and 11,281 completed all three doses. Over 48 months, 17 CIN2 + cases occurred: 3 among vaccine recipients (n = 5190) versus 14 among placebo recipients (n = 5167), corresponding to vaccine efficacy of 78.6% (95% CI 23.3-96.1; p = 0.012). No vaccine-related serious AEs occurred. Solicited local AEs were mainly mild pain, reported by 25.9% of vaccinees and 7.9% of placebo recipients. Fever was the most common systemic AE (27.4% vs. 26.4%). In the immunogenicity subset, 99.7% (349/350) and 99.4% (348/350) of vaccinees were seropositive for HPV16 and HPV18 neutralising antibodies, respectively, at Month 7. CONCLUSIONS: Three doses of HPV-2 were well tolerated, highly immunogenic, and efficacious against CIN2 + up to 4 years post-vaccination, supporting further evaluation in the adolescent target population for HPV vaccination campaigns. TRIAL REGISTRATION: China Drug Trials Registry (CTR20140626; registered Sept 26, 2014; prospective). CLINICALTRIALS: gov (NCT02733068; registered April 11, 2016; secondary).
Source: BMC Infectious Diseases
Authors: Liwei Shi, Xuefen Gao, Lili Huang, Zhao Gao, Juan Li, Bangwei Yu, Huilan Fan, Guohua Li, Yanxia Wang, Qi Li, Lin Yuan, Changgui Li, Zhaojun Mo, the HPV1003 Study group, Li Shi, Ke Li, Min Ji, Ya-Lin Hu, Ling-Yun Zhou, Xue-Mei Yan, Jing-Jing Chen, Wei Li, Zi-Long Wang, Zhen Huang, Yu-Liang Zhao, Rong-Cheng Li, Yan-Ping Li, Nian-Min Shi, Qiang Lu, Bin He, Shi-Fang Wen, Dong-Zhang Yang, Guo-Gang Liu, Yan-Xia Cai, Wei-Jiang Cui, Jiang-Bing Zheng, Zhan-Bo Geng, Yan-Hua Xie, Yong-Biao Ren, Hai-Song Zhou
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,090
OpenAlex ID: W4417452846