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一项基于日间护理的研究,研究了Haemophilus b多糖体疫苗的疗效

L H Harrison¹, C V Broome, A W Hightower

¹Division of Bacterial Diseases, Centers for Disease Control, Atlanta, GA 30333.

|September 9, 1988

概括

血红素b多糖疫苗的疗效为45%,低于预期. 在接种疫苗后的一周内,没有观察到海莫菲勒斯流感b型疾病的风险增加.

科学领域:

* 免疫学免疫学
* 流行病学流行病学
* 疫苗学疫苗学疫苗学

背景情况:

* 甲型流感血球菌 (Hib) 具有显著的疾病风险,特别是在幼儿中.
* 血红素b多糖疫苗 (HBPV) 是为了对抗Hib病而引入的.
*授权后对疫苗有效性和安全性的监测至关重要.

研究的目的:

*为了评估HBPV在获得许可后的真实世界疗效.
*通过检查立即接种疫苗后期的Hib疾病风险来评估HBPV的安全性.
* 确定病例控制研究对持续疫苗监测的有用性.

主要方法:

* 进行了一项基于托儿所的病例控制疗效研究.
*积极监测发现了3400万人口的入侵性Hib病例.
* 条件后勤回归分析了与疾病发病相对的疫苗有效性和接种时间.

主要成果:

* 估计HBPV疫苗的疗效为45% (95% CI:-1%至70%).
*在疾病发作前七天内接种疫苗并没有显示出Hib疾病的统计学上显著增加的风险 (OR = 1.8,95%CI:0.3到10.2).
*观察到的疗效低于从先前研究中预期的.

结论:

*HBPV的疗效似乎不如之前的试验所表明的效果.
* 该研究支持使用病例控制设计来监测许可后的疫苗疗效.
* 没有发现有关在接种疫苗后增加Hib病风险的直接安全问题.

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