A review of clinical trials of human papillomavirus prophylactic vaccines.
A review of clinical trials of human papillomavirus prophylactic vaccines.
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DOI：
10.1016/j.vaccine.2012.04.108
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发表时间：
2012-11-20
期刊：
影响因子：
5.5
通讯作者：
Garland SM
中科院分区：
文献类型：
--
作者：
Schiller JT;Castellsagué X;Garland SM
预防性人乳头瘤病毒（HPV）病毒样颗粒（VLP）疫苗在年轻女性中的III期试验的研究结束分析现已基本完成。评估了两种不同的疫苗，Gardasil®（Merck & Co.，怀特豪斯站，新泽西州，美国），一种含有6、11、16和18型VLP的四价疫苗和Cervarix®（GlaxoSmithKline Biologicals，里克森萨尔，比利时），一种含有16和18型VLP的二价疫苗。两种疫苗均表现出良好的安全性和免疫原性。对于从持续感染到宫颈上皮内瘤变3级（CIN 3）的一系列宫颈终点，疫苗对疫苗靶向类型的有效性也非常高，并且在接种时未接种相应类型的女性中具有相似的有效性。然而，对非疫苗类型的偶发感染或疾病的保护是有限的，疫苗对流行感染或疾病没有影响。Gardasil®还表现出对与疫苗类型相关的生殖器疣和外阴/阴道肿瘤的强大保护。在其他试验中，Gardasil®保护中年女性免受疫苗类型引起的偶发感染和CIN，并保护男性免受疫苗类型引起的偶发感染，生殖器疣和肛门上皮内瘤变。在研究结束评估中，Cervarix®可保护女性免受疫苗靶向的肛门感染。由于实际原因，尚未在当前疫苗接种计划的主要目标人群（青少年女孩和男孩）中进行有效性研究。然而，免疫原性桥接研究表明，在青春期具有良好的安全性和较强的免疫应答，加上在年轻成人中持久的抗体应答和保护的记录，导致对疫苗在青少年疫苗接种计划中的有效性的乐观预测。总之，出色的临床试验结果有力地支持了疫苗作为高价值公共卫生干预措施的潜力，并证明了其广泛实施以预防肛门生殖器HPV感染及其相关肿瘤的合理性。这篇文章是题为“全面控制HPV感染和相关疾病的机会”的特别增刊的一部分，疫苗第30卷，增刊X，2012年。
End of study analyses of the phase III trials of prophylactic human papillomavirus (HPV) virus-like particle (VLP) vaccines in young women are now largely completed. Two distinct vaccines were evaluated, Gardasil® (Merck & Co., Whitehouse Station, NJ USA) a quadrivalent vaccine containing VLPs of types 6, 11, 16 and 18 and Cervarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium), a bivalent vaccine containing VLPs of types 16 and 18. Both vaccines exhibited excellent safety and immunogenicity profiles. The vaccines also demonstrated remarkably high and similar efficacy against the vaccine-targeted types for a range of cervical endpoints from persistent infection to cervical intraepithelial neoplasia grade 3 (CIN3) in women naïve to the corresponding type at the time of vaccination. However, protection from incident infection or disease from non-vaccine types was restricted, and the vaccines had no effect on prevalent infection or disease. Gardasil® also demonstrated strong protection against genital warts and vulvar/vaginal neoplasia associated with the vaccine types. In other trials, Gardasil® protected mid-adult women from incident infection and CIN caused by the vaccine types and protected men for incident infection, genital warts and anal intraepithelial neoplasia by the vaccine types. Cervarix® protected against vaccine-targeted anal infections in women in an end of study evaluation. For practical reasons, efficacy studies have not been conducted in the primary target populations of current vaccination programs, adolescent girls and boys. However, immunogenicity bridging studies demonstrating excellent safety and strong immune responses in adolescence, coupled with the documentation of durable antibody responses and protection in young adults, leads to an optimistic projection of the effectiveness of the vaccines in adolescent vaccination programs. Taken together, the excellent clinical trial results strongly support the potential of the vaccines as high value public health interventions and justify their widespread implementation to prevent anogenital HPV infections and their associated neoplasia. This article forms part of a special supplement entitled “Opportunities for comprehensive control of HPV infections and related diseases” Vaccine Volume 30, Supplement X, 2012.