Zhao Fanghui, Chen Qi, Zhao Chao, Nie Lingling, Hu Shangying, Yin Jian, Qiu Lingxian, Bi Zhaofeng, Quan Jiali, Li Yufei, Li Mingzhu, Zhang Xun, Pan Qinjing, Li Caihong, Ke Lidong, Liu Xiaoli, Zheng Fengxian, Dai Cuihong, Wang Zhe, Kuang Xuefeng, Jia Xinhua, Su Yingying, Huang Shoujie, Zhang Qiufen, Huang Weijin, Wei Lihui, Zhang Jun, Wu Ting, Qiao Youlin, Xia Ningshao
National Cancer Centre, National Centre for Cancer Clinical Research, The Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.
State Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, Fujian, China.
Lancet Reg Health West Pac. 2025 Aug 21;61:101668. doi: 10.1016/j.lanwpc.2025.101668. eCollection 2025 Aug.
A safe and highly efficacious -produced HPV-16/18 bivalent vaccine (Cecolin®) offers a cost-effective cervical cancer prevention measure. Here, we report data on the long-term efficacy and immunopersistence up to 10 years post-vaccination.
In the Phase III clinical trial (NCT01735006), 7372 women were enrolled and randomly assigned to receive the HPV or control vaccine (hepatitis E vaccine). Women from 2 sites (Xinmi City and Fengning County; N = 1986) were invited to participate in the extension study. Cervical samples were collected for ThinPrep Pap tests and HPV DNA testing. Serum samples from participants in the immune persistent subcohort (N = 300) were collected for neutralising antibody testing. The co-primary outcomes were high-grade cervical, vulvar or vaginal lesions and persistent infection (over 6 months) associated with HPV 16/18 in the per-protocol population.
A total of 1648 women participated in the extension study (806 from the vaccine group and 842 from the control group). Over a median 10.2-year follow-up, vaccine efficacy was 87.5% (95% CI 6.4-99.7) against high-grade cervical, vulvar or vaginal lesions (1 case in the vaccine group and 8 cases in the control group, = 0.0391), and 97.0% (95% CI 78.9-100.0) against persistent infection (over 6 months, 1 case in the vaccine group and 32 cases in the control group, < 0.0001) in the per-protocol population. The GMCs of neutralising antibodies peaked by month 7, declined through month 42, with HPV-16 plateauing and HPV-18 continuing to decline thereafter. At 114 months, 98.9% (93/94) of baseline seronegative participants remained seropositive for HPV-16 with the GMC of 61.84 IU/mL and 97.0% (98/101) remained seropositive for HPV-18 with the GMC of 18.73 IU/mL.
The -produced HPV 16/18 bivalent vaccine elicits sustained antibody responses and confers durable protection against HPV 16/18 associated high-grade cervical, vulvar or vaginal lesions and persistent infections for a minimum of 10 years post-vaccination.
National Key Research and Development Program of China (2023YFC2307602), National Natural Science Foundation of China (823B2086, 82273640), Beijing Natural Science Foundation (L244091), and Fundamental Research Funds for the Central Universities (20720220005).
一种安全且高效生产的HPV-16/18二价疫苗（希克瑞®）提供了一种具有成本效益的宫颈癌预防措施。在此，我们报告了接种疫苗后长达10年的长期疗效和免疫持久性数据。
在III期临床试验（NCT01735006）中，招募了7372名女性，并随机分配接受HPV疫苗或对照疫苗（戊型肝炎疫苗）。邀请来自2个地点（新密市和丰宁县；N = 1986）的女性参与扩展研究。收集宫颈样本进行薄层液基细胞学检测和HPV DNA检测。收集免疫持久性亚组（N = 300）参与者的血清样本进行中和抗体检测。共同主要结局是符合方案人群中与HPV 16/18相关的高级别宫颈、外阴或阴道病变以及持续感染（超过6个月）。
共有1648名女性参与了扩展研究（疫苗组806名，对照组842名）。在中位10.2年的随访中，疫苗对高级别宫颈、外阴或阴道病变的疗效为87.5%（95%CI 6.4 - 99.7）（疫苗组1例，对照组8例，P = 0.0391），对持续感染（超过6个月）的疗效为97.0%（95%CI 78.9 - 100.0）（疫苗组1例，对照组32例，P < 0.0001）。中和抗体的几何平均浓度（GMC）在第7个月达到峰值，在第42个月下降，HPV-16随后趋于平稳，而HPV-18此后继续下降。在114个月时，98.9%（93/94）的基线血清学阴性参与者对HPV-16仍保持血清学阳性，GMC为61.84 IU/mL，97.0%（98/101）对HPV-18仍保持血清学阳性，GMC为18.73 IU/mL。
生产的HPV 16/18二价疫苗可引发持续的抗体反应，并在接种疫苗后至少10年内对HPV 16/18相关的高级别宫颈、外阴或阴道病变和持续感染提供持久保护。
中国国家重点研发计划（2023YFC2307602）、中国国家自然科学基金（823B2086、82273640）、北京市自然科学基金（L244091）以及中央高校基本科研业务费（20720220005）。
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