Present status of human papillomavirus vaccine development and implementation
Present status of human papillomavirus vaccine development and implementation
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DOI：
10.1016/s1470-2045(14)70481-4
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发表时间：
2015-05-01
期刊：
影响因子：
51.1
通讯作者：
Markowitz, Lauri E.
中科院分区：
文献类型：
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作者：
Herrero, Rolando;Gonzalez, Paula;Markowitz, Lauri E.
致癌性人乳头瘤病毒（HPV）感染是几乎所有宫颈癌和一部分其他肛门生殖器癌和口咽癌的原因。含有HPV 16和18的二价疫苗和含有HPV 6、11、16和18抗原的四价疫苗正在世界各地的疫苗接种计划中使用。在临床试验中，三剂疫苗可为接种时未感染的15-26岁女性提供90-100%的宫颈感染和与HPV 16和18相关的癌前病变保护。对其他HPV类型的部分交叉保护已被报道，但其持续时间未知。疫苗在预防两性其他解剖部位的HPV 16和18感染方面也有效。免疫印迹研究允许许可疫苗从9岁开始用于两性。两次给药方案引起高抗体浓度，因此建议9-14岁女孩采用两次给药方案。许可前和许可后研究提供了支持疫苗安全性的数据。2014年，一种含有HPV 6、11、16、18、31、33、45、52和58抗原的九价疫苗获得美国食品和药物管理局的许可。由于疫苗成本、物流挑战和相互竞争的卫生优先事项，HPV疫苗接种首先在高收入国家引入。自2011年以来，疫苗价格有所下降，使一些中等收入国家能够引进疫苗。2012年，免疫联盟为疫苗提供资金，在一些低收入国家开展了示范项目。到2014年，超过57个国家将HPV疫苗纳入其国家卫生计划。来自几个国家的数据显示了疫苗接种对HPV感染和相关疾病的影响，并提供了群体免疫的证据。目前正在开始向疾病负担最高的国家扩展计划，但需要进一步努力才能实现HPV疫苗的潜力。
Oncogenic human papillomavirus (HPV) infection is the cause of nearly all cervical cancers and a proportion of other anogenital and oropharyngeal cancers. A bivalent vaccine containing HPV 16 and 18 and a quadrivalent vaccine containing HPV 6, 11, 16, and 18 antigens are in use in vaccination programmes around the world. In clinical trials, three vaccine doses provided 90-100% protection against cervical infection and pre-cancer related to HPV 16 and 18 in women aged 15-26 years who were not infected at vaccination. Partial cross-protection against other HPV types has been reported but its duration is unknown. The vaccines were also efficacious at the prevention of HPV 16 and 18 infections at other anatomical sites in both sexes. Immunobridging studies allowed licensing of the vaccines for use starting at age 9 years for both sexes. Two-dose schedules elicit high antibody concentrations, leading to the recommendation of two-dose schedules for girls aged 9-14 years. Pre-licensure and post-licensure studies have provided data supporting vaccine safety. In 2014, a nonavalent vaccine containing HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antigens was licensed by the US Food and Drug Administration. HPV vaccination was first introduced in high-income countries owing to vaccine cost, logistic challenges, and competing health priorities. Since 2011, vaccine prices have lowered, allowing the introduction of the vaccine in some middle-income countries. Funding of the vaccine by the GAVI Alliance in 2012 led to demonstration projects in some low-income countries. By 2014, more than 57 countries had included the HPV vaccine in their national health programmes. Data from several countries have shown the effect of vaccination on HPV infection and associated disease, and provided evidence of herd immunity. Expansion of programmes to countries with the highest burden of disease is beginning, but further efforts are needed to realise the potential of HPV vaccines.