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GSK公布宫颈癌疫苗Cervarix III期HPV-70积极数据

来源:生物谷 2013-11-05 05:35

2013年11月5日讯 /生物谷BIOON/ --葛兰素史克(GSK)11月4日公布了宫颈癌疫苗Cervarix(人类乳头状瘤病毒16型和18型,重组)的一项III期研究的数据,研究结果表明,在9-14岁女生群体中,采用2针免疫程序(0,6个月)接种显示出了在15-25岁女生群体中3针免疫程序(0,1,6个月)相匹配的免疫原性(immunogenicity)。

该项研究名为HPV-070,涉及横跨5个国家的1447名女性(9-25岁),其中一组(9-14岁)采用2针免疫程序(0,6个月)接种,另一组(15-25岁)采用3针免疫程序(0,1,6个月)接种,数据表明,两组中诱导的免疫反应相当,表明2针免疫程序诱导的免疫反应质量和数量与3针免疫程序相当。

这些数据证实了另一项早期概念验证试验HPV-048的发现。HPV-048研究也评价了2针免疫程序相对于3针免疫程序的免疫原性,证明了在9-14岁女生中,2针免疫程序的免疫原性与15-25岁女生中采用3针免疫程序所观察到的免疫原性相当。

这些研究数据,将提交至在佛罗伦萨举行的EUROGIN会议。

目前,Cervarix已获欧盟批准用于9岁以上的女性,接种程序为3针免疫程序(0,1,6个月)。GSK于今年8月向欧洲药品管理局(EMA)提交了Cervarix 2针免疫程序(0,6个月)的上市许可申请(MAA),寻求批准以2针免疫程序(0,6个月)用于9-14岁女生的接种,用于预防与特定致癌类型人类乳头状瘤病毒(HPV)有关的生殖器癌前病变及宫颈癌。(生物谷Bioon.com)

英文原文:GSK announces data to support Cervarix? two-dose schedule for the prevention of cervical cancer in 9-14 year old girls

GlaxoSmithKline (GSK) plc today announced the results of a Phase III study of its HPV vaccine, Cervarix [Human papillomavirus (types 16 and 18) vaccine, recombinant], which showed that two doses of the vaccine in girls aged 9 to 14 years provide an immunogenicity matching the currently licensed three-dose schedule in 15 to 25 year olds.

In the trial, HPV-070, 1,447 patients (aged 9 to 25 years) across five countries were randomised to receive Cervarix. A group of girls aged 9 to 14 years received the vaccine in a two-dose schedule which was compared to another group of 15 to 25 year olds who received it as a three-dose schedule.

The results showed that the two-dose schedule in girls aged 9 to 14 years old induced immune responses which were comparable to that seen with the 3 dose schedule in 15 to 25 year olds suggesting quality and quantity of the immune response are comparable to the three-dose schedule.

The results corroborate the findings of an earlier proof of concept study, HPV-048, which also assessed the immunogenicity of two doses of Cervarix compared to its three-dose schedule and demonstrated that the immunogenicity of two doses of Cervarix in 9 to 14 year old girls is comparable to that seen with three doses in 15 to 25 year olds girls for both the vaccine HPV types 16 & 18 and for non-vaccine types 31 & 45, throughout the four year study period.

These findings consistently suggest that the immune response of the two-dose schedule in girls aged 9 to 14 years with Cervarix is in line with the three-dose schedule. Similarly, the safety profile is similar when compared to the three-dose group.

The results will be presented at today at the EUROGIN conference in Florence.

The vaccine is currently only approved in the EU for use in females from the age of nine years, administered according to a three-dose schedule (vaccination at months 0, one and six) for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.

A variation to the current Marketing Authorisation was submitted to the European Medicines Agency on August 7 2013 to add administration of the vaccine according to a two-dose schedule (0, 6 months) in girls aged 9 to 14 years old for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.

The use of Cervarix in a two-dose schedule vaccination at months 0 and six in girls aged 9 to 14 years old is approved in nine countries (including Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria & Ghana).Cervarix in a three-dose schedule is also approved in the US.

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