Lopalco Pier Luigi
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Drug Des Devel Ther. 2016 Dec 20;11:35-44. doi: 10.2147/DDDT.S91018. eCollection 2017.
Starting in 2006, vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries. Two vaccines have been successfully used, a bivalent vaccine targeting HPV-related cancers (bHPV) and a quadrivalent vaccine (qHPV) targeting both HPV-related cancers and genital warts. Between December 2014 and June 2015, a new nonavalent HPV vaccine (9vHPV) was granted marketing authorization in the USA and Europe. The 9vHPV was developed from the qHPV and includes five additional HPV types that should increase the level of protection toward HPV-related cancers. Efficacy and/or immunogenicity of 9vHPV has been assessed in eight clinical studies. The 9vHPV vaccine induced a very robust immune response against all vaccine types, with seroconversion rates close to 100%. The safety profile of 9vHPV is comparable to that of qHPV. Local reactions, especially swelling, have been more frequently reported after 9vHPV than qHPV, and this slightly increases when the 9vHPV is coadministered with other vaccines. The additional coverage offered by the 9vHPV may prevent a significant proportion of HPV-related cancers (variable between 8% and 18%) depending on the local distribution of high-risk HPV types in the population. It is impossible, at present, to anticipate the actual impact of the wide use of the 9vHPV in comparison with the bHPV or the qHPV, since it depends on many variables including duration of protection, potential cross-protection toward nonvaccine types, and herd immunity effect.
自2006年起，人乳头瘤病毒（HPV）疫苗已在大多数发达国家逐步推行。两种疫苗已成功投入使用，一种是针对HPV相关癌症的二价疫苗（bHPV），另一种是针对HPV相关癌症和尖锐湿疣的四价疫苗（qHPV）。2014年12月至2015年6月期间，一种新型九价HPV疫苗（9vHPV）在美国和欧洲获得上市许可。9vHPV由qHPV研发而来，新增了五种HPV类型，有望增强对HPV相关癌症的防护效果。八项临床研究评估了9vHPV的疗效和/或免疫原性。9vHPV疫苗对所有疫苗类型均能引发非常强烈的免疫反应，血清转化率接近100%。9vHPV的安全性与qHPV相当。与qHPV相比，9vHPV接种后更常出现局部反应，尤其是肿胀，当9vHPV与其他疫苗同时接种时，这种情况会略有增加。9vHPV提供的额外防护范围可能预防相当一部分HPV相关癌症（在8%至18%之间波动），具体比例取决于当地人群中高危HPV类型的分布情况。目前，与bHPV或qHPV相比，尚无法预测广泛使用9vHPV的实际影响，因为这取决于许多变量，包括保护期、对非疫苗类型的潜在交叉保护以及群体免疫效应。
