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首页> 外文期刊>The Journal of adolescent health: official publication of the Society for Adolescent Medicine >Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant.
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Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant.

机译：用含有AS04佐剂的16型和18型人乳头瘤病毒L1病毒样颗粒疫苗对青春期早期女性进行免疫。

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PURPOSE: In female individuals 15-25-years of age, the AS04-containing human papillomavirus (HPV)-16/18 vaccine is highly immunogenic and provides up to 100% protection against HPV-16/18 persistent infection and associated cervical lesions up to 4.5 years. Optimal cervical cancer prevention will require prophylactic vaccination against oncogenic HPV 16 and 18 before the onset of sexual activity in early adolescent girls. To establish the feasibility of vaccination in girls 10-14 years of age, we compared the immunogenicity and safety in early adolescent female individuals to those 15-25 years in whom vaccine efficacy has been demonstrated. METHODS: We enrolled 773 female participants aged 10-14 years and 15-25 years to receive the HPV-16/18 L1 VLP AS04 vaccine, which was administered at months 0, 1, and 6. Serum samples were collected at months 0 and 7; antibodies to HPV 16 and 18 VLPs were measured by enzyme-linked immunosorbent assay. Vaccine safety was assessed at 7 or 30 days after each dose; serious adverse events were recorded during the entire study period. RESULTS: Both age groups achieved 100% seroconversion for HPV 16 and 18. Participants in the group aged 10-14 years were not only noninferior to those 15-25 years in terms of HPV 16 and 18 seroconversion rates but also had approximately twice as high geometric mean titers. The vaccine was generally safe and well tolerated. CONCLUSIONS: These findings suggest that HPV vaccination during early adolescence is generally safe, well tolerated, and highly immunogenic. The observed higher antibody titers in the group 10-14 years of age are likely to result in longer antibody persistence. Overall, these data support the implementation of prophylactic HPV vaccination in this age group.
机译：目的：在15-25岁的女性个体中，含AS04的人乳头瘤病毒（HPV）-16/18疫苗具有高度的免疫原性，可针对HPV-16 / 18持续感染和相关宫颈病变提供高达100％的保护至4.5年。最佳的子宫颈癌预防将需要在青春期早期的女孩开始性活动之前对致癌的HPV 16和18进行预防接种。为了确定在10-14岁女孩中进行疫苗接种的可行性，我们将青春期早期女性个体与已证明疫苗功效的15-25岁女性的免疫原性和安全性进行了比较。方法：我们招募了773名年龄在10-14岁和15-25岁之间的女性参与者，分别在第0、1和6个月接受HPV-16 / 18 L1 VLP AS04疫苗的接种。 7;通过酶联免疫吸附试验测定了针对HPV 16和18 VLP的抗体。每次给药后7或30天评估疫苗的安全性;在整个研究期间记录了严重的不良事件。结果：两个年龄组的HPV 16和18血清转化率均达到100％。10-14岁组的参与者不仅在HPV 16和18血清转化率方面不亚于15-25岁，而且还高出大约两倍。几何平均滴度。该疫苗通常是安全的并且耐受性良好。结论：这些发现表明，青春期早期的HPV疫苗接种通常是安全的，耐受性良好且具有高度免疫原性。在10-14岁年龄组中观察到的更高的抗体滴度可能会导致更长的抗体持久性。总体而言，这些数据支持在该年龄段实施预防性HPV疫苗接种。

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