美国印第安人/阿拉斯加原住民婴儿的b型疫苗免疫性
Bianca D Jackson1, Karen Miernyk2, Jonathan Steinberg2
1Center for Indigenous Health.
Pediatrics
|September 24, 2024
概括
瓦克塞利斯疫苗在美国印第安人和阿拉斯加土著婴儿的第一剂后,与PedvaxHIB相比,显示出非劣质的Haemophilus influenzae type b (Hib) 免疫性. 这支持Vaxelis在高风险人群中的使用.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 儿科 儿科 儿科
背景情况:
- 美国印第安人和阿拉斯加土著 (AI/AN) 婴儿面临着侵袭性Hemophilus influenzae型b (Hib) 疾病的更高风险.
- 由于PedvaxHIB在第一剂后具有强烈的免疫原性,因此优先推给AI/AN婴儿.
- 六价疫苗Vaxelis含有与PedvaxHIB相同的Hib结合物,但度较低,因此需要AI/AN婴儿的免疫原性数据.
研究的目的:
- 为了比较VAXELIS和PEDVAXHIB疫苗在AI/AN婴儿的第一剂后免疫性.
- 为了确定Vaxelis是否在单剂后引起抗Hib抗体水平方面与PedvaxHIB无差.
主要方法:
- 进行了IV期,随机化,开放标签,非劣质性试验.
- AI/AN婴儿被随机分配给接受PedvaxHIB或Vaxelis.
- 使用ELISA测量了血清抗Hib免疫球蛋白G (IgG) 抗体水平,在第一剂后30天使用ELISA.
主要成果:
- 第一剂后抗Hib IgG抗体的几何平均度 (GMC) 为Vaxelis的0.41μg/mL,而PedvaxHIB的0.39μg/mL.
- GMC比率 (Vaxelis/PedvaxHIB) 为1.03,其中95%的置信区间为0.76-1.39.
- 95% CI (0.76) 的下限高于0.67.7的预定义的非劣势值.
结论:
- 在第一剂后,Vaxelis的免疫性被发现与PedvaxHIB无差.
- 这些发现支持在AI/AN儿童中使用Vaxelis,因为这些儿童患Hib病的风险增加.
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