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

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.

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Publication Details

Journal
npj Vaccines
Published
2025-12-17
DOI
https://doi.org/10.1038/s41541-025-01335-2
Primary Topic
Cervical Cancer and HPV Research
Type
article
Field-Weighted Citation Impact
0.00

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article

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

Ting Wu, Zhang Cheng-zong, Xiaowen Hu, Yuhang Peng et al.
npj Vaccines
Cervical Cancer and HPV Research
article

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

Ting Wu, Zhang Cheng-zong, Xiaowen Hu, Yuhang Peng, Huaijin Jiang, Shudan Shen, Kongxin Zhu, Chenxi Nie, Jianhua Xu, Yanqin Zhong, Jiali Quan, Ningshao Xia, Mengjun Liao, Bizhen Lin, Wenshuo Xu, Jie Chen, Jun Zhang, Yingying Su, Shaoxi Cai, Xianliang Wu, Shoujie Huang, Qi Chen
article en

Abstract

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.

npj VaccinesVol. 11(1)
Xiamen University (CN), Sinovac Biotech (CN)
National Natural Science Foundation of China, National Key Research and Development Program of China, Fundamental Research Funds for the Central Universities
Openalex Percentile: Top 47%
Cervical Cancer and HPV Research
DOIOpen Access PDFOpenAlex
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