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
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 stu...
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| Format: | Article |
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2418168 |
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| author | Yu Yang Liang Zhang Susanne Hartwig Peng Jiang Houyu Zhao Ruogu Meng Zhike Liu Zuoxiang Liu Keqin Ding Xuedan You Carol Koro Guozhang Xu Siyan Zhan |
| author_facet | Yu Yang Liang Zhang Susanne Hartwig Peng Jiang Houyu Zhao Ruogu Meng Zhike Liu Zuoxiang Liu Keqin Ding Xuedan You Carol Koro Guozhang Xu Siyan Zhan |
| author_sort | Yu Yang |
| collection | DOAJ |
| 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. |
| format | Article |
| id | doaj-art-d7cccfcf4f344d8db5b9d9bc82fa8d22 |
| institution | DOAJ |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-d7cccfcf4f344d8db5b9d9bc82fa8d222025-08-20T03:08:32ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2418168Post-marketing study design to evaluate the effectiveness of the 9-valent and 4-valent HPV vaccines on serious HPV-related cervical disease in ChinaYu Yang0Liang Zhang1Susanne Hartwig2Peng Jiang3Houyu Zhao4Ruogu Meng5Zhike Liu6Zuoxiang Liu7Keqin Ding8Xuedan You9Carol Koro10Guozhang Xu11Siyan Zhan12National Institute of Health Data Science, Peking University, Beijing, ChinaNingbo Municipal Center for Disease Control and Prevention, Ningbo, Zhejiang, ChinaBiostatistics and Research Decision Sciences (BARDS) Epidemiology, MSD, Lyon, FranceBiostatistics and Research Decision Sciences (BARDS) Epidemiology, MSD R&D (China) Co, Ltd., Beijing, ChinaSchool of Public Health, Peking University, Beijing, ChinaNational Institute of Health Data Science, Peking University, Beijing, ChinaSchool of Public Health, Peking University, Beijing, ChinaSchool of Public Health, Peking University, Beijing, ChinaNingbo Municipal Center for Disease Control and Prevention, Ningbo, Zhejiang, ChinaOutcome Research, Center for Observational and Real-world Evidence (CORE), Merck & Co. Inc., Upper Gwynedd, PA, USAMerck & Co., Inc., Rahway, NJ, USASchool of Public Health, Ningbo University, Ningbo, Zhejiang, ChinaNational Institute of Health Data Science, Peking University, Beijing, ChinaThe 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.https://www.tandfonline.com/doi/10.1080/21645515.2024.2418168Human papillomavirusvaccinecervical cancercervical intraepithelial neoplasiaNingboChina |
| spellingShingle | Yu Yang Liang Zhang Susanne Hartwig Peng Jiang Houyu Zhao Ruogu Meng Zhike Liu Zuoxiang Liu Keqin Ding Xuedan You Carol Koro Guozhang Xu Siyan Zhan 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 Human Vaccines & Immunotherapeutics Human papillomavirus vaccine cervical cancer cervical intraepithelial neoplasia Ningbo China |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Human papillomavirus vaccine cervical cancer cervical intraepithelial neoplasia Ningbo China |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2418168 |
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