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婴儿早期接种 B 群脑膜炎球菌疫苗后杀菌抗体的持久性和学前加强剂量的免疫原性。

Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose.

出版信息

CMAJ. 2013 Oct 15;185(15):E715-24. doi: 10.1503/cmaj.130257. Epub 2013 Sep 23.

Abstract

BACKGROUND

The multicomponent serogroup B meningococcal (4CMenB) vaccine was recently licensed for use in Europe. There are currently no data on the persistence of bactericidal antibodies induced by use of this vaccine in infants. Our objective was to evaluate serogroup B-specific bactericidal antibodies in children aged 40-44 months previously vaccinated at 2, 4, 6 and 12 months of age.

METHODS

Participants given 4 doses of 4CMenB as infants received a fifth dose of the vaccine at 40-44 months of age. Age-matched participants who were MenB vaccine-naive received 4CMenB and formed the control group. We evaluated human complement serum bactericidal activity (hSBA) titres at baseline and 1 month after each dose of 4CMenB.

RESULTS

Before a booster dose at enrolment, 41%-76% of 17 participants previously vaccinated with 4CMenB in infancy had hSBA titres of 4 or greater against 4 reference strains. Before vaccination in the control group (n = 40) these proportions were similar for strains 44/76-SL (63%) and M10713 (68%) but low for strains NZ98/254 (0%) and 5/99 (3%). A booster dose in the 4CMenB-primed participants generated greater increases in hSBA titres than in controls.

INTERPRETATION

As has been observed with other meningococcal vaccines, bactericidal antibodies waned after vaccination with 4CMenB administered according to an approved infant vaccination schedule of 2, 4, 6 and 12 months of age, but there was an anamnestic response to a booster dose at 40-44 months of age. If 4CMenB were introduced into routine vaccination schedules, assessment of the need for a booster dose would require data on the impact of these declining titres on vaccine effectiveness. ClinicalTrials.gov, no. NCT01027351.

摘要

背景

多组份 B 群脑膜炎奈瑟球菌(4CMenB)疫苗最近在欧洲获得许可使用。目前尚无关于该疫苗在婴儿中使用诱导的杀菌抗体持久性的数据。我们的目的是评估曾在 2、4、6 和 12 月龄接种过 4 剂 4CMenB 的 40-44 月龄儿童的 B 群特异性杀菌抗体。

方法

曾在婴儿期接种过 4 剂 4CMenB 的参与者在 40-44 月龄时接种第五剂疫苗。与接种过 MenB 疫苗的年龄匹配的参与者为 4CMenB 疫苗初免者,形成对照组。我们在接种每剂 4CMenB 前后评估人补体血清杀菌活性(hSBA)滴度。

结果

在入组时进行加强剂接种前,曾在婴儿期接种过 4CMenB 的 17 名参与者中有 41%-76%对 4 株参考株的 hSBA 滴度为 4 或更高。在对照组(n=40)中,这些比例与 44/76-SL(63%)和 M10713(68%)株相似,但与 NZ98/254(0%)和 5/99(3%)株较低。在 4CMenB 初免参与者中接种加强剂产生的 hSBA 滴度增加大于对照组。

解释

与其他脑膜炎球菌疫苗一样,按照批准的婴儿接种时间表(2、4、6 和 12 月龄)接种 4CMenB 后,杀菌抗体减弱,但在 40-44 月龄时对加强剂有回忆反应。如果 4CMenB 被引入常规疫苗接种计划,评估是否需要加强剂需要关于这些下降滴度对疫苗效力的影响的数据。ClinicalTrials.gov,编号 NCT01027351。

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