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Impact of HPV vaccination in preventing subsequent infection and disease after excision treatment

Impact of HPV vaccination in preventing subsequent infection and disease after excision treatment

Fanghui Zhao

National Cancer Center & Cancer Hospital, Chinese Academy of Medical Sciences


Professor Zhao was CO-PI of the project GSK-107638.Shangying Hu was an investigator in charge of study coordination and data management generated in the center lab in the project GSK-107638.

26 June 2018

Bivalent human papillomavirus (HPV) vaccine have been approved by CFDA in China. Bivalent vaccine is highly effective in preventing cervical intraepithelial neoplasia grade II/III in women who are not infected the relevant HPV type before vaccination. However, the impacts of vaccine on the women who have previously been treated have not been fully understood.
Women who are previously treated for cervical cancers represent higher risk group for the development of subsequent cervical cancer (2 to 6-fold higher risk compared to women with normal cytology). More recently, previously results from both randomized and non-randomized studies have suggested a possible benefit of vaccination to prevent the recurrence of precursor lesions and disease after excisional treatment of prevalent disease. One study showed that rates of disease after treatment for cervical or vaginal HPV associated disease was reduced among those who were vaccine before treatment. The vaccine efficacy against recurrent HPV related disease was 46.2%. However, the impacts of HPV vaccination in preventing subsequent infection and disease after excision treatment are requesting more scientific data to support.
The clinical study GSK-107638 included Chinese women aged 18-25 years at the first time of vaccination. Cervical samples for HPV DNA testing and cervical cytology samples were collected at each study visit. Biopsy and excisional treatment specimens were analyzed by a panel of three expert gynecological pathologists. This research is based on the previous clinical study GSK-107638 which consists of participants who were randomized and vaccinated, who are treated during the follow-up period. The primary outcome is the recurrence of HPV related precursor lesions after treatment. And the secondary outcome of this study is HPV infection, persistent HPV infection (defined as positive for the detection of type-specific HPV at two or more consecutive visits after treatment), and squamous intraepithelial lesion (SIL). Besides, we also consider the outcomes related to HPV type present and absent before surgery, respectively.
This study compares these outcomes between vaccine group and placebo group, aiming at exploring the protective effect of vaccine on women who have undergone surgery for cervical disease. This reaearch will provide evidence for the impact of the vaccine on the women who are treated for cervical disease and expanding the application of vaccine in women.

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Statistical Analysis Plan

Zhao, S., Hu, S., Xu, X. et al. Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: post-hoc analysis from a randomized controlled trial. BMC Infect Dis 20, 846 (2020).