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单剂甲型肝炎免疫接种:在尼加拉瓜儿童中进行的 7.5 年观察性试点研究,以评估保护效力和体液免疫记忆应答。

Single-Dose Hepatitis A Immunization: 7.5-Year Observational Pilot Study in Nicaraguan Children to Assess Protective Effectiveness and Humoral Immune Memory Response.

机构信息

Department of Microbiology & Parasitology, Faculty of Medical Sciences, National Autonomous University, León, Nicaragua.

Epidemiology, Biostatistics and Prevention Institute, University of Zürich.

出版信息

J Infect Dis. 2016 Nov 15;214(10):1498-1506. doi: 10.1093/infdis/jiw411. Epub 2016 Sep 6.

DOI:10.1093/infdis/jiw411
PMID:27601623
Abstract

BACKGROUND

Universal 2-dose hepatitis A virus (HAV) vaccination of toddlers effectively controls hepatitis A. High vaccine costs, however, impede implementation in endemic countries. To test single-dose vaccination as a possible alternative, we initiated an observational, longitudinal study in Nicaragua, to assess protective effectiveness and-through challenge vaccination-humoral immune memory response.

METHODS

After a 2003 serosurvey, 130 originally seronegative children received one dose of virosomal HAV vaccine in 2005, followed by yearly serological and clinical assessments until 2012. After 7.5 years, a vaccine booster was administered. Concurrent antibody screening of patients presenting with hepatitis symptoms documented persistent HAV circulation in the communities studied.

RESULTS

Between serosurvey and vaccination, 25 children contracted hepatitis A subclinically (>8000 mIU/mL anti-HAV). In the remaining 105 children, immunization resulted in anti-HAV levels of 17-572 mIU/mL. Based on the ≥15% annual infection risk, an estimated 60% of children were exposed to HAV encounters during follow-up. No child presented with hepatitis symptoms. Serological breakthrough infection (7106 mIU/mL) was documented in 1 child, representing an estimated protective effectiveness of 98.3% (95% confidence interval, 87.9-99.8). Boosting elicited an average 29.7-fold increase of anti-HAV levels.

CONCLUSIONS

In children living in hyperendemic settings, a single dose of virosomal HAV vaccine is sufficient to activate immune memory and may provide long-term protection.

摘要

背景

为了有效控制甲型肝炎,给幼儿接种两剂通用型甲型肝炎病毒(HAV)疫苗。然而,疫苗费用高昂,阻碍了在流行地区的实施。为了检验单剂疫苗接种作为一种可能的替代方法,我们在尼加拉瓜启动了一项观察性、纵向研究,评估保护效力,并通过挑战疫苗接种评估体液免疫记忆反应。

方法

在 2003 年进行血清调查后,130 名最初血清阴性的儿童在 2005 年接受了一剂病毒体 HAV 疫苗,随后每年进行血清学和临床评估,直到 2012 年。7.5 年后,进行了疫苗加强接种。同时对出现肝炎症状的患者进行抗体筛查,证明研究社区中持续存在甲型肝炎病毒传播。

结果

在血清调查和疫苗接种之间,有 25 名儿童亚临床感染了甲型肝炎(抗-HAV 抗体>8000 mIU/mL)。在其余 105 名儿童中,免疫接种导致抗-HAV 水平为 17-572 mIU/mL。根据每年>15%的感染风险,估计在随访期间有 60%的儿童接触到了 HAV 。没有儿童出现肝炎症状。有 1 名儿童发生了血清学突破性感染(7106 mIU/mL),估计保护效力为 98.3%(95%置信区间,87.9-99.8)。加强接种可使抗-HAV 水平平均增加 29.7 倍。

结论

在生活在高度流行地区的儿童中,一剂病毒体 HAV 疫苗足以激活免疫记忆,并可能提供长期保护。

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