新型 A（H1N1）疫苗在 HIV 感染儿童中的免疫原性。

The immunogenicity of a novel A (H1N1) vaccine in HIV-infected children.

机构信息

Vaccine Institute, St. George's, University of London, London, United Kingdom.

出版信息

Vaccine. 2011 Sep 2;29(38):6636-40. doi: 10.1016/j.vaccine.2011.06.103. Epub 2011 Jul 13.

DOI:10.1016/j.vaccine.2011.06.103

PMID:21742005

Abstract

BACKGROUND

In October 2009, the United Kingdom Department of Health recommended vaccination of high-risk groups, including children with HIV, with a novel, oil-in-water AS03(B) adjuvanted Influenza A (H1N1) vaccine (Pandemrix). There were no published data available regarding the immunogenicity of this vaccine in such children.

OBJECTIVES

This study evaluated the immunogenicity of the adjuvanted Influenza A (H1N1) vaccine in HIV-infected children immunised according to national recommendations and assessed the impact of vaccination on individual CD4 counts and HIV viral loads.

METHODS

HIV-infected children attending outpatient appointments between 01 November and 31 December 2009 were offered two doses of H1N1 vaccine three weeks apart and a blood test before and 3 weeks after the second dose of vaccine. Serum antibody responses were determined by a haemagglutination inhibition (HAI) assay using standard methods.

RESULTS

Of the 39 children recruited for vaccination, 31 (median age 11.2, range 3.0-17.9 years) received both doses of vaccine and provided pre- and post-vaccination blood samples. Eight children (26%) had baseline HAI titres ≥ 1:32. After vaccination, 29 children (94%, 95% CI, 78.6-99.2%) had HAI titres ≥ 1:32 (seroprotection), of whom 27 (87.1%, 95% CI, 70.1-96.4%) had also had a four-fold rise in titres (seroconversion). In the univariate analysis, post-vaccination geometric mean titres (GMTs) were higher among the 21 children receiving highly active anti-retroviral therapy compared with the 10 treatment-naïve children (GMT 406 [95% CI 218-757] vs. 128 [49-336]; P=0.035), but this was no longer statistically significant when adjusted for prevaccine GMTs. There was no significant impact of vaccination on CD4+ T cell count or HIV viral load.

CONCLUSION

The AS03(B)-adjuvanted pandemic Influenza A (H1N1) vaccine is highly immunogenic and appears to be safe in HIV-infected children.

摘要

背景

2009 年 10 月，英国卫生部建议为包括 HIV 儿童在内的高危人群接种新型水包油佐剂流感 A（H1N1）疫苗（Pandemrix）。尚无关于该疫苗在这些儿童中的免疫原性的已发表数据。

目的

本研究评估了根据国家建议为 HIV 感染儿童接种佐剂流感 A（H1N1）疫苗的免疫原性，并评估了疫苗接种对个体 CD4 计数和 HIV 病毒载量的影响。

方法

2009 年 11 月 1 日至 12 月 31 日期间，在门诊就诊的 HIV 感染儿童被提供两剂 H1N1 疫苗，间隔 3 周，并在第二剂疫苗后 3 周进行一次血液检查。血清抗体反应通过使用标准方法的血凝抑制（HAI）测定来确定。

结果

在接种疫苗的 39 名儿童中，有 31 名（中位年龄 11.2 岁，范围 3.0-17.9 岁）接受了两剂疫苗接种，并提供了接种前和接种后的血液样本。8 名儿童（26%）基线 HAI 滴度≥1:32。接种疫苗后，29 名儿童（94%，95%CI，78.6-99.2%）的 HAI 滴度≥1:32（血清保护），其中 27 名（87.1%，95%CI，70.1-96.4%）的滴度也增加了四倍（血清转化率）。在单变量分析中，接受高效抗逆转录病毒治疗的 21 名儿童与未接受治疗的 10 名儿童相比，接种后几何平均滴度（GMT）更高（GMT406[95%CI218-757]比 128[49-336]；P=0.035），但在调整疫苗前 GMT 后，这不再具有统计学意义。疫苗接种对 CD4+T 细胞计数或 HIV 病毒载量没有显著影响。