Patel M
National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT 0200, Australia.
Cochrane Database Syst Rev. 2000(2):CD001093. doi: 10.1002/14651858.CD001093.
Controlled trials over two decades ago showed that the polysaccharide vaccine prevented meningococcal meningitis. Subsequent observational studies suggested variations in the level and duration of protection, particularly among young children.
To determine the effect of polysaccharide serogroup A vaccine for preventing serogroup A meningococcal meningitis.
MEDLINE and the Cochrane Controlled Trials Register.
Randomised and other prospective controlled trials.
One reviewer collected data and assessed the methodologic quality of the trials. Data were pooled using the Exact method to assess vaccine efficacy at one, two and three years post-vaccination.
The protective effect within the first year was consistent across all eight trials, including one with participants exclusively under six years of age (in Finland); overall vaccine efficacy was 95% (Exact 95% CI 87%, 99%). The Finnish trial lacked statistical power to assess the effect of a booster dose given to children less than 18 months old. In the three other trials that included children less than six years old (one in Sudan and two in Nigeria), none of the vaccinated children developed meningitis, but the statistical significance of this finding was undetermined. Protection extended into the second (in two studies) and third (in one study) years after vaccination, but these results were also not statistically significant.
REVIEWER'S CONCLUSIONS: When compared with current recommendations, the methodological quality and relative incompleteness of the published reports could arguably render the trials invalid for this review. However, it was unlikely that the results of the trials in such diverse settings would have been biased towards a strong and consistent protective effect. Immunogenicity trials were not included in this review. Stage two of the review will assess the vaccine effect from observational studies.
二十多年前的对照试验表明,多糖疫苗可预防脑膜炎球菌性脑膜炎。随后的观察性研究显示,保护水平和持续时间存在差异,尤其是在幼儿中。
确定A群多糖疫苗预防A群脑膜炎球菌性脑膜炎的效果。
MEDLINE和Cochrane对照试验注册库。
随机及其他前瞻性对照试验。
一名评价员收集数据并评估试验的方法学质量。采用确切概率法汇总数据,以评估接种疫苗后1年、2年和3年的疫苗效力。
在所有八项试验中,第一年的保护效果是一致的,其中一项试验的参与者均为6岁以下儿童(芬兰);总体疫苗效力为95%(确切概率法95%可信区间87%,99%)。芬兰的试验缺乏评估给予18个月以下儿童加强剂量效果的统计学效力。在其他三项纳入6岁以下儿童的试验中(一项在苏丹,两项在尼日利亚),接种疫苗的儿童均未发生脑膜炎,但这一结果的统计学意义尚未确定。保护作用可延续至接种疫苗后的第二年(两项研究)和第三年(一项研究),但这些结果也无统计学意义。
与当前建议相比,已发表报告的方法学质量和相对不完整性可认为使这些试验对本评价无效。然而,在如此多样的环境中进行的试验结果不太可能偏向于强烈且一致的保护作用。本评价未纳入免疫原性试验。评价的第二阶段将评估观察性研究中的疫苗效果。