Conterno L O, Silva Filho C R, Rüggeberg J U, Heath P T
Marilia Medical School - FAMEMA, Department of Medicine, Avenida Monte Carmelo 800, Fragata, Marilia, São Paulo, Brazil 17519-030.
Cochrane Database Syst Rev. 2006 Jul 19(3):CD001834. doi: 10.1002/14651858.CD001834.pub2.
Meningococcal polysaccharide (MPLS) vaccines protect against Serogroup C disease, but do not produce an immune response in infants less than two years of age. This limitation can be overcome by linking C polysaccharide to carrier proteins ('conjugating'), to create meningococcal serogroup C conjugate (MCC) vaccines. In the absence of trial data, the immune response to vaccination has been considered to be a reasonable surrogate for vaccine protection.
To assess the immunogenicity, safety and efficacy of MCC vaccines for preventing meningitis and septicaemia.
We searched the Cochrane Central Register Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2005); MEDLINE (1966 to September, Week 1 2005); and EMBASE (1990 to June 2005) and references of studies.
Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) in humans comparing MCC vaccines against a control vaccine or none. In the absence of any trials on vaccine efficacy, population-based observational studies about effectiveness were included.
Two authors independently screened the results of the literature searches, selected eligible studies, extracted the data and evaluated the quality of them.
The studies showed that MCC vaccine was highly immunogenic in infants after two and three doses, in toddlers after one and two doses and in older age groups after one dose. In general higher titres were generated after MCC than after MPLS vaccines. Immunological hypo-responsiveness seen after repeated doses of MPLS vaccine may be overcome with MCC. Observational studies have documented a significant decline in meningococcal C disease in countries where MCC vaccines have been widely used. The timing of the vaccinations schedules, the specific conjugate used, and the vaccines given concomitantly or combined, may be important.
AUTHORS' CONCLUSIONS: The MCC vaccine appears to be safe, immunogenic and able to induce immunological memory in all age groups. Observational studies strongly suggest that MCC is clinically effective.
脑膜炎球菌多糖(MPLS)疫苗可预防C群疾病,但对两岁以下婴儿不会产生免疫反应。通过将C多糖与载体蛋白连接(“结合”)以制备脑膜炎球菌C群结合(MCC)疫苗,可克服这一局限性。在缺乏试验数据的情况下,对疫苗接种的免疫反应被视为疫苗保护作用的合理替代指标。
评估MCC疫苗预防脑膜炎和败血症的免疫原性、安全性及有效性。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(2005年第3期《Cochrane图书馆》)、MEDLINE(1966年至2005年9月第1周)和EMBASE(1990年至2005年6月)以及各研究的参考文献。
比较MCC疫苗与对照疫苗或不接种疫苗的人体随机对照试验(RCT)和对照临床试验(CCT)。若没有关于疫苗有效性的试验,则纳入基于人群的有效性观察性研究。
两位作者独立筛选文献检索结果,选择符合条件的研究,提取数据并评估其质量。
研究表明,MCC疫苗在婴儿接种两剂和三剂后、幼儿接种一剂和两剂后以及大龄组接种一剂后具有高度免疫原性。总体而言,MCC疫苗接种后产生的抗体滴度高于MPLS疫苗接种后产生的滴度。重复接种MPLS疫苗后出现的免疫低反应性可能通过MCC疫苗得以克服。观察性研究记录了在广泛使用MCC疫苗的国家中,脑膜炎球菌C群疾病显著减少。疫苗接种计划的时间安排、使用的特定结合物以及同时接种或联合接种的疫苗可能很重要。
MCC疫苗似乎安全、具有免疫原性且能够在所有年龄组诱导免疫记忆。观察性研究有力地表明MCC在临床上是有效的。