关键词: HPV vaccination clinical trial long-term effect real-world data seropositivity HPV vaccination clinical trial long-term effect real-world data seropositivity HPV vaccination clinical trial long-term effect real-world data seropositivity

来  源:   DOI:10.3390/vaccines10020256

Abstract:
The preventive effect of HPV vaccines against anogenital and oropharyngeal cancers has been proven in both clinical trials and real-world data. We reviewed the published evidence about the long-term efficacy and effectiveness of the HPV vaccine in available papers of clinical trials and real-world data. As far as we searched, the longest period of preventive effect for the bivalent, 4-valent, and 9-valent vaccine were 11 years in the Costa Rica trial, 14 years in the FUTURE II, and 8 years in the LTFU extension study of V503-002 and the Scandinavian study, respectively. The sustained clinical effect during the observation period was longest for the 4-valent vaccine. In real-world data, the longest observation period of the vaccine effectiveness was 12 years in an Australian study for the 4-valent vaccine. On the other hand, the longest period of long-term persistence of HPV vaccine-induced seropositivity was 14 years in FUTURE II for the 4-valent vaccine. For the bivalent vaccine, additional long-term follow-up studies may not have been planned due to the launch of the 4-valent and 9-valent vaccines. In some studies of the 9-valent vaccine, the results have not yet been published because of the short observation period. The additional results are expected in the future. In a national immunization program, most girls and boys are inoculated with HPV vaccine by the time puberty begins; thus, it is important to monitor the vaccine effect at least until the sexually active period in their 20s and 30s.
摘要:
HPV疫苗对肛门生殖器癌和口咽癌的预防作用已在临床试验和现实世界数据中得到证实。我们回顾了已发表的关于HPV疫苗的长期疗效和有效性的临床试验和现实世界数据的可用论文的证据。据我们搜索,二价的最长预防效果,4价,9价疫苗在哥斯达黎加试验中有11年,未来的14年,在LTFU对V503-002的扩展研究和斯堪的纳维亚研究中进行了8年,分别。4价疫苗在观察期间的持续临床效果最长。在现实世界的数据中,在澳大利亚的一项4价疫苗研究中,疫苗有效性的最长观察期为12年.另一方面,在FUTUREII中,4价疫苗的HPV疫苗诱导的血清阳性长期持续时间最长为14年.对于二价疫苗,由于4价和9价疫苗的推出,可能没有计划额外的长期随访研究.在一些9价疫苗的研究中,由于观察时间短,结果尚未公布。预计未来还会有额外的结果。在国家免疫计划中,大多数女孩和男孩在青春期开始时接种了HPV疫苗;因此,重要的是至少在20多岁和30多岁的性活跃期之前监测疫苗效果。
公众号