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Original Article | Open Access

Long-term protective efficacy of the Escherichia coli-produced HPV-16/18 bivalent human papillomavirus vaccine in women vaccinated at 18–45 years: A 9-year follow-up study

Xinhua Jiaa,b,1, Shangying Hub,1, Xuefeng Kuangb, Youlin Qiaoa,b ( )
School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

1 These authors contributed equally to this work.

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Highlights

• Long-term efficacy assessment: evaluated the protective efficacy of the recombinant HPV 16/18 bivalent vaccine over a 9-year period post-vaccination.

• Phase Ⅲ clinical trial follow-up: conducted a long-term follow-up study based on the phase Ⅲ clinical trial (NCT01735006) in Xinmi, Henan Province, China.

• Significant protective efficacy: demonstrated high protective efficacy against HPV-16 and HPV-18 infections, exceeding 82% in both ITT and mITT analyses.

• Sustained protection against HPV-18: observed 100% protective efficacy against HPV-18 infection after nine years.

• Support for vaccine longevity: findings indicate the bivalent HPV vaccine provides sustained long-term protection against HPV-16/18 infections for at least nine years.

Abstract

Background

To assess the enduring protective efficacy of the recombinant human papilloma virus (HPV) 16/18 bivalent vaccine (produced in Escherichia coli) in preventing HPV infection.

Methods

A long-term follow-up study was conducted in Xinmi, Henan Province, in September 2022, 9 years post-administration of the initial vaccine dose. This study was grounded in the phase Ⅲ clinical trial of the vaccine (NCT01735006). Participants were recalled to collect exfoliated cervical cells for HPV DNA genotyping. The long-term protective efficacy of the vaccine against HPV infection was evaluated using Poisson distribution.

Results

A total of 1123 volunteers were recalled, comprising 558 individuals in the experimental group and 565 in the control group, with mean ages of 30.80 ± 7.33 years and 30.64 ± 7.51 years, respectively. At baseline (0 days before vaccination), 147 participants (13.09%) were infected with any type of HPV. By the ninth year of follow-up, the overall HPV infection rate within the entire cohort had increased to 16.65%. In the intention-totreat analysis, the demonstrated protective efficacy against HPV-16, HPV-18, and HPV-16/18 was 83.12% (95% confidence interval [CI]: 24.20–98.17), 100.00% (95% CI: −10.50 to 100.00) and 87.34% (95% CI: 46.17–98.59), respectively. In the modified intention-to-treat analysis, the protective efficacy of the vaccine against HPV-16, HPV-18, and HPV-16/18 was 82.90% (95% CI: 23.20–98.14), 100.00% (−10.71 to 100.00), and 87.36% (95% CI: 46.20–98.59), respectively.

Conclusions

Vaccination with the bivalent HPV vaccine offers long-term protection against HPV-16/18 infections for at least 9 years.

Keywords

Human papilloma virusHuman papilloma virus infectionHuman papilloma virus vaccineLong-term follow-upProtective efficacy

References

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Infectious Medicine
Volume 4 Issue 1,
March 2025
Article number: 100164
DOI: 10.1016/j.imj.2025.100164

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Cite this article:
Jia X, Hu S, Kuang X, et al. Long-term protective efficacy of the Escherichia coli-produced HPV-16/18 bivalent human papillomavirus vaccine in women vaccinated at 18–45 years: A 9-year follow-up study. Infectious Medicine, 2025, 4(1): 100164. https://doi.org/10.1016/j.imj.2025.100164

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Received: 23 October 2024
Revised: 11 December 2024
Accepted: 09 January 2025
Published: 01 March 2025
© 2025 The Authors.

This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)