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下一代人乳头瘤病毒疫苗:九价疫苗V503即将问世。

The next generation of HPV vaccines: nonavalent vaccine V503 on the horizon.

作者信息

Chatterjee Archana

机构信息

University of South Dakota Sanford School of Medicine - Pediatrics, 1400 W 22nd St. Sioux Falls SD 57103, UK.

出版信息

Expert Rev Vaccines. 2014 Nov;13(11):1279-90. doi: 10.1586/14760584.2014.963561. Epub 2014 Sep 26.

DOI:10.1586/14760584.2014.963561
PMID:25256262
Abstract

HPV infection with 'high-risk' genotypes is associated with ano-genital and oropharyngeal cancers. Two currently licensed prophylactic HPV vaccines designed to prevent disease associated with HPV 16 and 18 are in use around the world. Both vaccines have very high efficacy for prevention of vaccine type-associated cervical precancers, preventing approximately 70% of these lesions. Quadrivalent HPV vaccine has also been shown to prevent HPV16/18-associated vaginal, vulvar and anal precancers, and HPV6/11-associated ano-genital warts. To broaden protection against HPV genotypes not in the current vaccines, 'second-generation' vaccines with additional genotypes are under development. Merck, Sharp and Dohme has submitted a Biologics License Application for its investigational nonavalent HPV vaccine V503 to the US FDA, with standard review being granted. The nonavalent HPV vaccine appears to be safe and effective in preventing persistent infection and precancerous lesions associated with HPV types 16/18/31/33/45/52/58, as well as genital warts related to HPV types 6 and 11.

摘要

感染“高危”基因型的人乳头瘤病毒(HPV)与肛门生殖器癌和口咽癌有关。目前有两种已获许可的预防性HPV疫苗,旨在预防与HPV 16和18相关的疾病,正在全球范围内使用。这两种疫苗对预防疫苗型相关的宫颈上皮内瘤变具有很高的效力,可预防约70%的此类病变。四价HPV疫苗也已被证明可预防HPV16/18相关的阴道、外阴和肛门上皮内瘤变,以及HPV6/11相关的肛门生殖器疣。为了扩大对当前疫苗中未包含的HPV基因型的保护,正在研发具有更多基因型的“第二代”疫苗。默克公司已向美国食品药品监督管理局(FDA)提交了其研究性九价HPV疫苗V503的生物制品许可申请,并获得了标准审评。九价HPV疫苗在预防与HPV 16/18/31/33/45/52/58型相关的持续感染和癌前病变以及与HPV 6和11型相关的生殖器疣方面似乎是安全有效的。

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