Journal of the National Cancer Center · 2025
Ten-year evaluation of HPV vaccine influence on non-vaccine-type-related cervical infections and precancers in Chinese females: follow-up from a randomized control trial.
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Wen Tianmeng, Dun Changchang, Hu Shangying, Pan Qinjing, Zhang Xun, Zhao Fanghui
Аннотация
OBJECTIVE: The long-term influence of human papillomavirus (HPV) vaccination on untargeted types is poorly understood. The study assessed the influence of AS04-HPV-16/18 vaccination on non-vaccine-type infections and precancers through post-hoc analyses of a 10-year follow-up of China's first HPV vaccine trial.
METHODS: In the clinical trial, females aged 18-25 years (N = 6051) were randomized 1:1 to receive either three doses of AS04-HPV-16/18 vaccine or control and followed for 6 years. After this trial, all participants were invited to an extended 10-year follow-up. The present post-hoc analyses evaluated cross-protection and type replacement based on virological and pathological endpoints.
RESULTS: The AS04-HPV-16/18 vaccine provided 43.15 % (95 % CI: 20.17 %-59.96 %) cross-protection against 6-month persistent infections related to HPV-31/33/45, while cross-protection against other non-vaccine types (HPV-35/39/51/52/56/58/59/66/68) was non-significant. Notably, an increase in non-vaccine-preventable-type-related cervical intraepithelial neoplasia of grade 2 (CIN2) or worse was noted in the vaccine group (attributable proportion: 48.40 %), compared to 29.52 % in the control group (P = 0.020). No significant differences in incidence or prevalence of non-vaccine-preventable-type infections were found between groups.
CONCLUSIONS: A significant increase in precancers caused by the non-vaccine-preventable types was demonstrated, despite no evidence of viral replacement 10 years post-vaccination.
METHODS: In the clinical trial, females aged 18-25 years (N = 6051) were randomized 1:1 to receive either three doses of AS04-HPV-16/18 vaccine or control and followed for 6 years. After this trial, all participants were invited to an extended 10-year follow-up. The present post-hoc analyses evaluated cross-protection and type replacement based on virological and pathological endpoints.
RESULTS: The AS04-HPV-16/18 vaccine provided 43.15 % (95 % CI: 20.17 %-59.96 %) cross-protection against 6-month persistent infections related to HPV-31/33/45, while cross-protection against other non-vaccine types (HPV-35/39/51/52/56/58/59/66/68) was non-significant. Notably, an increase in non-vaccine-preventable-type-related cervical intraepithelial neoplasia of grade 2 (CIN2) or worse was noted in the vaccine group (attributable proportion: 48.40 %), compared to 29.52 % in the control group (P = 0.020). No significant differences in incidence or prevalence of non-vaccine-preventable-type infections were found between groups.
CONCLUSIONS: A significant increase in precancers caused by the non-vaccine-preventable types was demonstrated, despite no evidence of viral replacement 10 years post-vaccination.