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. 2022 Sep;113(9):3211-3220.
doi: 10.1111/cas.15471. Epub 2022 Jul 11.

Effectiveness of human papillomavirus vaccine against cervical precancer in Japan: Multivariate analyses adjusted for sexual activity

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Effectiveness of human papillomavirus vaccine against cervical precancer in Japan: Multivariate analyses adjusted for sexual activity

Risa Kudo et al. Cancer Sci. 2022 Sep.

Abstract

Japanese girls aged 12-16 years are offered free human papillomavirus (HPV) vaccination and cervical cancer screening is conducted with cytology and not HPV testing from the age of 20 years. So far, no study has analyzed the effect of HPV vaccination against cervical precancers considering HPV infection status and sexual activity. We aimed to analyze the vaccine effectiveness (VE) against HPV infection and cytological abnormalities, adjusted for sexual activity. This study comprised women aged 20-26 years who underwent cervical screening in Niigata. We obtained HPV vaccination status from municipal records and a questionnaire along with information concerning sexual activity. Of 5194 women registered for this study, final analyses included 3167 women in the vaccinated group (2821 vaccinated women prior to sexual debut) and 1386 women in the unvaccinated group. HPV 16/18 (0.2% vs 3.5%), 31/45/52 (3.4% vs 6.6%), and 31/33/45/52/58 (5.0% vs 9.3%) positive rates were significantly lower in the vaccinated group (P < 0.001). No women vaccinated before sexual debut had HPV 16/18-related cytological abnormalities. VE for HPV 16/18 infection and high-grade cytological abnormalities in women vaccinated prior to sexual debut were 95.8% (95% CI 81.9-99.0%; P < 0.001) and 78.3% (95% CI 11.3-94.7%; P = 0.033), respectively, in multivariate analyses adjusted for age and number of sexual partners. However, analyses of all vaccinated women did not show significant effectiveness against cytological abnormalities. Our results showed the effectiveness of HPV vaccine against high-grade cervical cytological abnormalities and the importance of the vaccination before sexual debut.

Keywords: HPV infection; HPV vaccine; cervical cancer; cytological abnormality; sexual activity.

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Conflict of interest statement

M. Y., Y. U., and T. E. have received lecture fees from Merck Sharp and Dohme. E. M. received honoraria and lecture fees from Roche Diagnostics, Hologic Japan, and Merck Sharp and Dohme. All other authors report no potential conflicts.

Figures

FIGURE 1
FIGURE 1
Classification of human papillomavirus (HPV) vaccination status based on municipal immunization records and self‐reporting. Of the 5194 participants, 3167 were officially confirmed to have received the HPV vaccine. Of the 2026 women who did not have a record of HPV vaccination, 1386 women self‐reported that they had not been vaccinated. Therefore, the final analysis included 3167 women in the vaccinated group and 1386 women in the unvaccinated group
FIGURE 2
FIGURE 2
Human papillomavirus (HPV) infection rate in women with abnormal cytology by HPV vaccination status. The proportion of HPV16/18‐infected patients in the ASC‐US+ was 2.0% (3/148) in the vaccinated group compared with the 16.8% (17/101) in the unvaccinated group. The proportion of HPV 16/18‐infection in those with HSIL+ was 18.2% (2/11) in the vaccinated group compared with the 38.5% (5/13) in the unvaccinated group. None of the cytological abnormalities associated with HPV16/18 infection were observed in the vaccinated group before sexual debut

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