Robert Koch Institute, Immunization Unit, Seestrasse 10, 13353 Berlin, Germany.
Robert Koch Institute, Immunization Unit, Seestrasse 10, 13353 Berlin, Germany.
J Infect. 2017 Aug;75(2):81-94. doi: 10.1016/j.jinf.2017.05.001. Epub 2017 May 6.
Human serum bactericidal antibody levels (hSBA) are commonly used as an immune correlate of protection after vaccination against meningococcal disease. We performed a systematic review of how well this marker correlates with protection induced by outer membrane vesicle (OMV) vaccines against meningococcal B (MenB) disease.
To compare vaccine effectiveness (VE) of OMV vaccines against MenB predicted by hSBA (predicted protection) to VE from clinical studies (observed protection).
Studies identified by searching Medline, Embase, Global Health, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects.
Studies reporting hSBA after vaccination with OMV vaccines and subsequent efficacy/effectiveness in a MenB outbreak were included.
Data extraction and risk of bias assessments were performed by two independent investigators.
Predicted VE and observed VE measured during MenB outbreaks.
We included 19 studies (eleven randomized controlled trials, six cohort studies, two case-control studies). Four different OMV vaccines were applied during nine different outbreaks (six countries, 1987-2009). A comparison between predicted and observed VE was possible using results from studies performed during five outbreaks. Predicted VE differed from observed VE by 2-59%, with greater differences observed in younger age groups. In general, predicted VE tended to be lower than observed VE. CONCLUSION AND RELEVANCE: hSBA induced by OMV vaccines correlates moderately well with protection against MenB in older children and adults. The correlation was poor at very young ages, for which low VE was observed.
人血清杀菌抗体水平（hSBA）通常用作接种脑膜炎球菌病疫苗后免疫保护的相关指标。我们对该标志物与针对脑膜炎 B 型（MenB）疾病的外膜囊泡（OMV）疫苗诱导的保护之间的相关性进行了系统评价。
比较 OMV 疫苗对 MenB 的疫苗有效性（VE）预测值（通过 hSBA 预测的保护）与临床研究中的 VE（观察到的保护）。
通过搜索 Medline、Embase、全球健康、Cochrane 对照试验中心注册库、Cochrane 系统评价数据库和效果摘要数据库来确定研究。
纳入报告接种 OMV 疫苗后 hSBA 情况以及随后在 MenB 暴发期间有效性/效果的研究。
由两名独立研究者进行数据提取和偏倚风险评估。
在 MenB 暴发期间测量预测 VE 和观察 VE。
我们纳入了 19 项研究（11 项随机对照试验、6 项队列研究、2 项病例对照研究）。在 9 次暴发期间使用了 4 种不同的 OMV 疫苗（6 个国家，1987-2009 年）。使用在 5 次暴发中进行的研究结果可以比较预测 VE 和观察 VE。预测 VE 与观察 VE 的差异为 2-59%，在年龄较小的人群中观察到的差异更大。一般来说，预测 VE 倾向于低于观察 VE。结论和相关性：OMV 疫苗诱导的 hSBA 与儿童和成人对 MenB 的保护相关性较好。在年龄很小的人群中相关性较差，观察到 VE 较低。
