Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloška 4, 1000 Ljubljana, Slovenia.
Vaccine. 2018 Aug 28;36(36):5416-5423. doi: 10.1016/j.vaccine.2017.07.113. Epub 2017 Aug 8.
Prophylactic human papillomavirus (HPV) vaccine represents a revolutionary step forward in preventing HPV-related cancers, especially cervical carcinoma. Alongside appropriate screening, it has the potential to dramatically reduce cervical cancer incidence and even eradicate it. Following extensive evaluations in clinical trials, the first decade of routine HPV vaccine use provides overwhelming evidence of the vaccines' safety and their real-life effectiveness. In 2016, further clinical trials showed high vaccine efficacy in adult women, especially those that were HPV DNA-negative at baseline, and indicated possible protection from HPV-related diseases after treatment of precancerous cervical lesions. The recommendation for a two-dose schedule in individuals under 15 is further supported for all three licensed vaccines by immunogenicity studies that show non-inferior immune responses and similar clinical efficacy compared to the three-dose schedule. So far, natural competition between HPV types has not been confirmed and therefore vaccine-induced clinically significant type replacement is unlikely. The real-world effectiveness data showed cross-sectional reduction in the prevalence/incidence of vaccine-related HPV types, genital warts and precancerous cervical lesions in countries and regions with HPV vaccination coverage. These declines were evident not only in vaccinated females, but also in unvaccinated females and males, strongly suggesting herd protection. Despite an excellent safety profile consistently demonstrated in clinical trials and confirmed in real-life settings, recently invented controversial syndromes allegedly linked to HPV vaccines temporarily compromised some previously very successful vaccination programs and significantly contributed to the failure of HPV vaccine implementation in some countries with the highest prevalence of cervical cancer. However, several safety studies failed to confirm any association of these syndromes with HPV vaccination in various settings and geographic locations. The main challenges remain implementing HPV vaccination in national vaccination programs, especially in low-and middle-income countries with the highest burden of cervical cancer, and achieving and sustaining high vaccine coverage rates.
预防性人乳头瘤病毒（HPV）疫苗的问世代表着预防 HPV 相关癌症，尤其是宫颈癌的一大突破。除了适当的筛查，它还有可能显著降低宫颈癌的发病率，甚至彻底消除宫颈癌。经过临床试验的广泛评估，HPV 疫苗常规使用的第一个十年提供了压倒性的证据，证明了疫苗的安全性及其在现实生活中的有效性。2016 年，进一步的临床试验表明，疫苗在成年女性中的有效性很高，尤其是那些基线时 HPV DNA 阴性的女性，并且表明在治疗癌前宫颈病变后可能对 HPV 相关疾病有保护作用。基于免疫原性研究显示，与三剂方案相比，所有三种已获许可的疫苗在 15 岁以下人群中采用两剂方案也具有非劣效免疫应答和相似的临床疗效，因此进一步支持了两剂方案的建议。到目前为止，尚未证实 HPV 型之间存在自然竞争，因此疫苗诱导的具有临床意义的类型替代不太可能发生。在 HPV 疫苗接种覆盖的国家和地区，真实世界的有效性数据显示，疫苗相关 HPV 型、生殖器疣和癌前宫颈病变的流行率/发病率呈横断面下降。这些下降不仅在接种疫苗的女性中可见，而且在未接种疫苗的女性和男性中也可见，强烈表明群体保护。尽管临床试验中始终表现出良好的安全性，并在现实环境中得到证实，但最近发明的据称与 HPV 疫苗相关的有争议的综合征暂时影响了一些以前非常成功的疫苗接种计划，并在一些宫颈癌发病率最高的国家导致 HPV 疫苗实施的失败。然而，一些安全性研究未能在各种环境和地理位置证实这些综合征与 HPV 疫苗接种之间存在任何关联。主要挑战仍然是在国家疫苗接种计划中实施 HPV 疫苗接种，尤其是在宫颈癌负担最高的中低收入国家，以及实现和维持高疫苗接种率。
