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<p>Data on the immunopersistence of one- or two-dose regimens of HPV vaccine in women aged 18–45 remains scarce. During 5.5-year follow-up of a Phase 3 clinical trial of Cecolin<sup>®</sup> (ClinicalTrials.gov, NCT01735006), blood samples were collected at day 0, month 7 and annually thereafter for neutralizing antibody measurement. Cervical samples were collected for ThinPrep Pap tests and HPV genotyping. At month 66, HPV-16 seropositive rates were 100.0% across all groups (single-dose, two-dose [0–1-month], two-dose [0-6-month], and three-dose). HPV-18 seropositive rates were 63.6%, 93.8%, 84.6% and 98.4%, respectively. Although geometric mean concentrations (GMCs, IU/mL) of neutralizing antibodies in the one- and two-dose groups were lower than in the three-dose group (HPV-16: 10.4, 46.0 and 46.9 vs 72.4; HPV-18: 5.3, 12.0 and 17.1 vs 35.9), they remained higher than levels induced by natural infection (HPV-16: 2.8; HPV-18: 2.3). One- or two-dose of Cecolin<sup>®</sup> demonstrated immunogenic in women aged 18–45 up to 5.5 years.</p>

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Immunopersistence of one or two doses of an Escherichia coli produced bivalent HPV vaccine

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月17日

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  • Mengjun Liao,
  • Jiali Quan,
  • Kongxin Zhu,
  • Xiaowen Hu,
  • Shudan Shen,
  • Jianhua Xu,
  • Chu Nie,
  • Weizhuo Xu,
  • Hexuan Jiang,
  • Xianliang Wu,
  • Yanqin Zhong,
  • Yuhang Peng,
  • Shihui Cai,
  • Jie Chen,
  • Chengzong Zhang,
  • Bizhen Lin,
  • Yingying Su,
  • Shoujie Huang,
  • Qi Chen,
  • Ting Wu,
  • Jun Zhang,
  • Ningshao Xia

摘要

Data on the immunopersistence of one- or two-dose regimens of HPV vaccine in women aged 18–45 remains scarce. During 5.5-year follow-up of a Phase 3 clinical trial of Cecolin® (ClinicalTrials.gov, NCT01735006), blood samples were collected at day 0, month 7 and annually thereafter for neutralizing antibody measurement. Cervical samples were collected for ThinPrep Pap tests and HPV genotyping. At month 66, HPV-16 seropositive rates were 100.0% across all groups (single-dose, two-dose [0–1-month], two-dose [0-6-month], and three-dose). HPV-18 seropositive rates were 63.6%, 93.8%, 84.6% and 98.4%, respectively. Although geometric mean concentrations (GMCs, IU/mL) of neutralizing antibodies in the one- and two-dose groups were lower than in the three-dose group (HPV-16: 10.4, 46.0 and 46.9 vs 72.4; HPV-18: 5.3, 12.0 and 17.1 vs 35.9), they remained higher than levels induced by natural infection (HPV-16: 2.8; HPV-18: 2.3). One- or two-dose of Cecolin® demonstrated immunogenic in women aged 18–45 up to 5.5 years.