中国育龄女性中人乳头瘤病毒型别竞争及型别替换研究

预防性HPV疫苗有望最终减少甚至消灭由疫苗型别导致的疾病负担，但目前的疫苗并未覆盖HPV所有型别，人们始终关注在实施有效的HPV疫苗接种计划后，是否会发生“型别替换”。目前对于HPV疫苗接种后是否存在型别替换尚无统一定论。随着4种HPV疫苗在我国陆续上市，有必要对HPV型别竞争与型别替换进行研究。本研究拟在国产HPV16/18双价疫苗临床试验的基础上继续随访，（1）通过随机对照临床试验延续性监测验证HPV疫苗型别与非疫苗型别交叉保护、型别竞争和型别替换是否存在；（2）通过病例对照研究探讨HPV疫苗型别与非疫苗型别交叉保护、型别竞争和型别替换存在的可能机制；（3）通过理论流行病学研究，构建HPV传播动力学模型，以预测实施HPV疫苗免疫规划后HPV型别替换的风险。从而系统的阐明我国育龄女性中HPV型别竞争、交叉保护和型别替换等问题，为我国宫颈癌的预防控制、疫苗免疫策略的制定提供科学依据。

Human papillomavirus (HPV) infection can cause a serious disease burden. Prophylactic HPV vaccine is expected to eventually reduce or even eliminate the burden of disease attributable to vaccine type. However, current preventive vaccines do not cover all types of HPV, a concerned has been raised that following implementing a national HPV vaccination programs it may lead to “type replacement”. There is currently no consensus on whether there is a type replacement after HPV vaccination. With four HPV vaccines being launched in China, it is necessary to study HPV type competition and type replacement. Based on the phase III clinical trial of HPV16/18 bivalent vaccine in China, this study intends to follow up participants in clinical trials. This study intent to (1) evaluate the potential for human papillomavirus type replacement postvaccination by random clinical trial; (2) explore the mechanism for human papillomavirus type replacement postvaccination by case control study; (3) predict the risk of HPV type replacement after implementing the HPV vaccine immunization program by susceptible-infected-recovered-susceptible heterosexual transmission model. These data from this study can elucidate HPV type competition, cross protection and type replacement and provides clues for the prevention and control of cervical cancer and the formulation of vaccine immunization strategies in China.