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LANCET INFECT DIS:新型登革热疫苗对2-17岁儿童及青少年安全有效

2017-03-30 MedSci MedSci原创

新型疫苗对于2-17岁儿童是安全有效的,2剂量的疫苗可以有效的提高未发病儿童对3型和4型登革热病毒的抵抗力

登革热是人类常见的蚊媒传染病,媒介控制难以阻止它在世界范围内的传播。供9岁以上人群使用的登革热疫苗现已上市,但还需要研发对于所有年龄段、所有血清型登革病毒(DENV1-4)都有效的新型疫苗。研究人员就新型4价登革热疫苗的安全性和免疫原性进行了研究,其结果发表于近日的The Lancet Infectious Diseases。

研究人员在多米尼加、巴拿马和菲律宾开展了II期随机、双盲、安慰剂对照试验。试验参与者为2-17岁的健康志愿者,随机分配接种疫苗(0.5mL)或安慰剂。试验的主要终点是第一次注射1,3,6个月后,对1-4型登革热病毒的抗体的几何平均效价(GMTs);安全评价作为次要终点。

1794名志愿者参与试验,其中200人在第0和第3个月接种2剂量的疫苗(第一组);398人在第0个月接种一次(第二组);998人在第0个月接种一次之后第12个月再强化一次(第三组);198人接种安慰剂。疫苗产生的抗体在第一个月达到峰值并在6个月时仍保持较高水平。6个月时,第一组的抗体GMTs为489(95% CI 321-746),第二组为1434(95% CI 306-615),第三组为2532(95% CI 384-738),安慰剂组为62(95% CI 32-120);疫苗对于2-4型登革热病毒都产生抗体;没有与疫苗接种相关的严重不良事件发生。

研究表明,该新型疫苗对于2-17岁儿童是安全有效的,2剂量的疫苗可以有效的提高未发病儿童对3型和4型登革热病毒的抵抗力,目前的数据足以支持开展该疫苗的III期临床研究。

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    2017-05-15 howi
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    2017-04-01 doctorJiangchao

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