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3 月龄健康婴儿单次接种脑膜炎奈瑟菌 C 群结合疫苗的免疫原性:英国研究

Immunogenicity of a single dose of meningococcal group C conjugate vaccine given at 3 months of age to healthy infants in the United kingdom.

机构信息

Vaccine Evaluation Unit, Health Protection Agency, Manchester Medical Microbiology Partnership, Manchester Royal Infirmary, Manchester, United Kingdom.

出版信息

Pediatr Infect Dis J. 2012 Jun;31(6):616-22. doi: 10.1097/INF.0b013e31824f34e6.

Abstract

BACKGROUND

From 1999, in the United Kingdom, meningococcal C conjugate (MCC) vaccines from 3 manufacturers were introduced to the infant immunization schedule at 2, 3 and 4 months of age. In 2006, the schedule was refined to a 2-dose primary schedule at 3 and 4 months of age, with a combined MCC/Haemophilus influenzae type b (MCC/Hib-TT) booster at 12 months of age. Recent data have demonstrated that 2 of the 3 MCC vaccines showed potential for use as a single priming dose in infancy.

METHODS

A randomized trial was undertaken with 2 MCC vaccines; one using tetanus toxoid carrier protein (MCC-TT) and one using CRM197 carrier protein (MCC-CRM197). Infants were immunized with MCC at 3 months of age followed by an MCC/Hib-TT booster at 12 months of age.

RESULTS

The serum bactericidal antibody geometric mean titers 1 month after a single dose of MCC-TT or MCC-CRM 197 were 223.3 (95% confidence interval [CI]: 162.9-306.1) and 95.8 (95% CI: 66.4-138.2) with 100% and 95.5% of infants having serum bactericidal antibody titers ≥ 8, respectively. Before boosting, antibody titers had declined, and 1 month after the MCC/Hib-TT booster, serum bactericidal antibody geometric mean titers rose to 2251.0 (95% CI: 1535.3-3300.3) and 355.9 (95% CI: 235.4-538.1) for children primed with MCC-TT and MCC-CRM 197, respectively.

CONCLUSIONS

In conclusion, a single priming dose of either MCC-TT or MCC-CRM197 administered at 3 months of age can be used together with the Hib/MCC-TT booster in the second year of life.

摘要

背景

自 1999 年以来,英国将三种制造商生产的脑膜炎球菌 C 结合疫苗(MCC)引入婴幼儿免疫计划,于 2、3 和 4 个月大时接种。2006 年,计划调整为在 3 和 4 个月大时进行两剂基础免疫,在 12 个月大时接种一剂 MCC/流感嗜血杆菌 b 型(MCC/Hib-TT)加强针。最近的数据表明,三种 MCC 疫苗中的两种可能作为婴幼儿单剂基础免疫使用。

方法

进行了一项随机试验,使用了两种 MCC 疫苗;一种使用破伤风类毒素载体蛋白(MCC-TT),另一种使用 CRM197 载体蛋白(MCC-CRM197)。婴儿于 3 个月大时接种 MCC,然后于 12 个月大时接种 MCC/Hib-TT 加强针。

结果

接种 MCC-TT 或 MCC-CRM197 单剂后 1 个月,血清杀菌抗体几何平均滴度分别为 223.3(95%置信区间 [CI]:162.9-306.1)和 95.8(95% CI:66.4-138.2),分别有 100%和 95.5%的婴儿血清杀菌抗体滴度≥8。加强针前,抗体滴度下降,在接种 MCC/Hib-TT 加强针后 1 个月,用 MCC-TT 和 MCC-CRM197 进行基础免疫的儿童血清杀菌抗体几何平均滴度分别升高至 2251.0(95% CI:1535.3-3300.3)和 355.9(95% CI:235.4-538.1)。

结论

总之,在 3 个月大时接种单剂 MCC-TT 或 MCC-CRM197,可与第二年的 Hib/MCC-TT 加强针联合使用。

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