Post-marketing study design to evaluate the effectiveness of the 9-valent and 4-valent HPV vaccines on serious HPV-related cervical disease in China
Creators: name: Yang, Yu
name: Zhang, Liang
name: Hartwig, Susanne
name: Jiang, Peng
name: Zhao, Houyu
name: Meng, Ruogu
name: Liu, Zhike
name: Liu, Zuoxiang
name: Ding, Keqin
name: You, Xuedan
name: Koro, Carol
name: Xu, Guozhang
name: Zhan, Siyan
Publisher: name: Taylor & Francis
Year: 2024
Subjects: subject: Medicine
subject: Biotechnology
subject: Sociology
subject: FOS: Sociology
subject: Immunology
subject: FOS: Clinical medicine
subject: Mathematical Sciences not elsewhere classified
subject: Cancer
subject: Mental Health
subject: Infectious Diseases
subject: FOS: Health sciences
subject: Virology
subject: Computational Biology

description: The 4-valent (4 v) and 9-valent (9 v) human papillomavirus (HPV) vaccines are approved in China for females aged 9–45 years. However, the real-world impact of 4vHPV or 9vHPV vaccination for the prevention of high-grade cervical disease in Chinese women is lacking. Two post-marketing surveillance studies will be conducted to measure the occurrence of high-grade cervical lesions in Chinese women who had received ≥1 dose of the 4vHPV (aged 20–45 years) or 9vHPV (aged 16–26 years) vaccine in Ningbo, China. Vaccination data will be extracted from the Ningbo Regional Health Information Platform (NRHIP) from the date of the first 4vHPV (January 9, 2018) or the first 9vHPV (January 25, 2019) vaccination to March 31, 2021. The primary 4vHPV and 9vHPV vaccinated cohorts will include women vaccinated per protocol. The 4vHPV/9vHPV vaccinated test-negative (cervical HPV negative; ThinPrep cytology test negative) and corresponding matched unvaccinated HPV test-negative sub-cohorts will also be assessed. Outcomes will be the occurrence of new-onset cervical intraepithelial neoplasia grade 2/3, adenocarcinoma in situ, and invasive cervical cancer. This study aims to demonstrate that such a methodological approach is feasible and can be used to assess the impact of HPV vaccination in other regions across China. Women who are infected with the human papillomavirus (HPV) can develop serious cervical diseases, which include cervical cancer. In China, several vaccines can be given to adult women to prevent HPV infection, and as a result, prevent serious cervical diseases. For the 4-valent and 9-valent HPV vaccines, there is not enough information on how effective these two HPV vaccines are at stopping Chinese women from developing serious cervical disease. As a result, we will conduct two studies to measure how often serious cervical disease occurs in Chinese women who received the 4-valent HPV (aged 20–45 years) or 9-valent HPV (aged 16–26 years) vaccine in Ningbo, China. Information on HPV vaccination from a database called the Ningbo Regional Health Information Platform (NRHIP) will be collected from the date of the first 4-valent HPV (January 9, 2018) or the first 9-valent HPV (January 25, 2019) vaccination to March 31, 2021. During these two observation periods, we will measure how often new cases of serious cervical diseases occur in Chinese women who have been vaccinated with the 4-valent HPV or 9-valent HPV vaccines and who do not have HPV vaccination. The objective of our studies is to measure the effectiveness of HPV vaccination at preventing serious cervical diseases in women in a region of China.