Sangar Vikrant Chadrakant, Ghongane Balasaheb, Mathur Gaurav
Department of Pharmacology, B.J. Govt. Medical College and Sassoon General Hospital, Pune-411001, India.
Rev Recent Clin Trials. 2016;11(4):284-289. doi: 10.2174/1574887111666160502160748.
The casual relationship concerning Human papillomaviruses (HPV) and cervical cancer is already established. Therefore, such HPV-associated malignancies might be prevented by prophylactic HPV vaccines. From 2009, two prophylactic HPV L1 Virus-Like Particle vaccines namely, Gardasil®; - quadrivalent (Merck) and Cervarix™ - bivalent (GlaxoSmithKline) are widely commercially available. By Aug 2014, 58 countries had introduced HPV vaccination in their national immunization program; this has led to numerous publications on safety and real world effectiveness. We have also seen long-term immunogenicity and efficacy data emerging. Data on cross-protection has also evolved. In clinical trials, it is observed that vaccinating adolescents results in higher immunological response than young adults hence to achieve best HPV vaccine efficacy it is advisable to immunize before the onset of sexual activity. Recently we have seen development of 2 dose vaccine schedule for adolescent, and emerging evidences even point that single dose of HPV vaccines can result in high efficacy, this observation is currently under consideration but if accepted will greatly impact vaccination coverage. In terms of safety, pregnancy registry did not find any unexpected patterns in fetal or maternal outcomes. This review only focuses on the efficacy and safety data of both Food and Drug Administration approved vaccines from clinical phase I to phase IV.
人乳头瘤病毒(HPV)与宫颈癌之间的因果关系已经确立。因此,此类与HPV相关的恶性肿瘤或许可通过预防性HPV疫苗来预防。自2009年起,两种预防性HPV L1病毒样颗粒疫苗,即加德西(Gardasil®)四价疫苗(默克公司)和希瑞适(Cervarix™)二价疫苗(葛兰素史克公司)已广泛上市。截至2014年8月,58个国家已将HPV疫苗接种纳入其国家免疫规划;这引发了大量关于安全性和实际效果的出版物。我们也看到了长期免疫原性和疗效数据的出现。交叉保护的数据也有所发展。在临床试验中,观察到为青少年接种疫苗比为年轻人接种能产生更高的免疫反应,因此为实现最佳HPV疫苗疗效,建议在开始性行为之前进行免疫接种。最近,我们看到了针对青少年的2剂疫苗接种方案的发展,而且新出现的证据甚至表明单剂HPV疫苗也能产生高效,这一观察结果目前正在考虑之中,但如果被接受,将极大地影响疫苗接种覆盖率。在安全性方面,妊娠登记未发现胎儿或产妇结局有任何意外情况。本综述仅关注美国食品药品监督管理局批准的疫苗从I期到IV期临床试验的疗效和安全性数据。