Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months:: interim analysis of a randomised clinical trial
Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months:: interim analysis of a randomised clinical trial
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DOI：
10.1136/bmj.a661
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发表时间：
2008-08-09
影响因子：
105.7
通讯作者：
Aaby, Peter
中科院分区：
文献类型：
--
作者：
Martins, Cesario L.;Garly, May-Lill;Aaby, Peter
目的探讨低收入国家9个月前婴儿接种麻疹疫苗的保护效果。设计随机临床试验。参与者1333名4.5个月的婴儿：实验组441例，对照组892例。研究地点：几内亚比绍城市地区。采用标准滴度Edmonston-4.5月龄时接种萨格勒布疫苗。主要结果测量疫苗对麻疹感染的有效性，麻疹住院，和9月龄标准疫苗接种前麻疹死亡率。在4.5个月大时接受检测的儿童中，有30%在入学时母体麻疹抗体达到保护水平。早期接种麻疹疫苗后，92%的儿童在9个月大时就有麻疹抗体。麻疹暴发为检验早期麻疹疫苗接种的有效性提供了独特的情况。在爆发期间，96名儿童患上麻疹; 19%未接种疫苗的儿童在9个月大之前患上麻疹。441名入组治疗组的儿童麻疹月发病率为0.7%，892名入组对照组的儿童麻疹月发病率为3.1%。早期接种Edmonston-Zagreb麻疹疫苗可预防感染;疫苗对血清学确诊麻疹和确诊临床麻疹的儿童的有效性为94%（95%置信区间为77%至99%），对因麻疹住院的儿童的有效性为100%（46%至100%），对麻疹死亡率的有效性为100%（-42%至100%）。在流行期间，为预防一例4.5个月至9个月的麻疹病例，需要治疗的人数为7.2（6.8至9.2）。治疗组往往有较低的总体死亡率（死亡率比0.18，0.02至1.36），虽然这是不显着的。结论在低收入国家，母亲对麻疹的抗体水平可能较低，严重的麻疹暴发可能发生在婴儿前的建议接种年龄在9个月。早在4.5个月大时使用Edmonston-Zagreb疫苗接种麻疹疫苗可减少麻疹的爆发。试验注册临床试验NCT 00168558 [ClinicalTrials.gov]。
Objective To examine the protective efficacy of measles vaccination in infants in a low income country before 9 months of age.Design Randomised clinical trial.Participants 1333 infants aged 4.5 months: 441 in treatment group and 892 in control group.Setting Urban area in Guinea-Bissau.Intervention Measles vaccination using standard titre Edmonston-Zagreb vaccine at 4.5 months of age.Main outcome measures Vaccine efficacy against measles infection, admission to hospital for measles, and measles mortality before standard vaccination at 9 months of age.Results 28% of the children tested at 4.5 months of age had protective levels of maternal antibodies against measles at enrolment. After early vaccination against measles 92% had measles antibodies at 9 months of age. A measles outbreak offered a unique situation for testing the efficacy of early measles vaccination. During the outbreak, 96 children developed measles; 19% of unvaccinated children had measles before 9 months of age. The monthly incidence of measles among the 441 children enrolled in the treatment arm was 0.7% and among the 892 enrolled in the control arm was 3.1%. Early vaccination with the Edmonston-Zagreb measles vaccine prevented infection; vaccine efficacy for children with serologically confirmed measles and definite clinical measles was 94% (95% confidence interval 77% to 99%), for admissions to hospital for measles was 100% (46% to 100%), and for measles mortality was 100% (-42% to 100%). The number needed to treat to prevent one case of measles between ages 4.5 months and 9 months during the epidemic was 7.2 (6.8 to 9.2). The treatment group tended to have lower overall mortality (mortality rate ratio 0.18, 0.02 to 1.36) although this was not significant.Conclusions In low income countries, maternal antibody levels against measles may be low and severe outbreaks of measles can occur in infants before the recommended age of vaccination at 9 months. Outbreaks of measles may be curtailed by measles vaccination using the Edmonston-Zagreb vaccine as early as 4.5 months of age.Trial registration Clinical Trials NCT00168558 [ClinicalTrials.gov].