免疫缺陷人群中单价 2009 年甲型 H1N1 流感疫苗的免疫原性：一项比较 HIV 感染者和 HIV 阴性成人的前瞻性研究。
Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults.
机构信息
Infectious Disease Clinical Research Program, Uniformed Services University of Health Sciences, Bethesda, Maryland, USA.
出版信息
Clin Infect Dis. 2011 Jan 1;52(1):138-46. doi: 10.1093/cid/ciq019. Epub 2010 Dec 7.
BACKGROUND
Limited data exist on the immunogenicity of the 2009 influenza A (H1N1) vaccine among immunocompromised persons, including those with human immunodeficiency virus (HIV) infection.
METHODS
We compared the immunogenicity and tolerability of a single dose of the monovalent 2009 influenza A (H1N1) vaccine (strain A/California/7/2009H1N1) between HIV-infected and HIV-uninfected adults 18-50 years of age. The primary end point was an antibody titer of ≥ 1:40 at day 28 after vaccination in those with a prevaccination level of ≤ 1:10, as measured by hemagglutination-inhibition assay. Geometric mean titers, influenza-like illnesses, and tolerability were also evaluated.
RESULTS
One hundred thirty-one participants were evaluated (65 HIV-infected and 66 HIV-uninfected patients), with a median age of 35 years (interquartile range, 27-42 years). HIV-infected persons had a median CD4 cell count of 581 cells/mm(3) (interquartile range, 476-814 cells/mm(3)) , and 82% were receiving antiretroviral medications. At baseline, 35 patients (27%) had antibody titers of >1:10. HIV-infected patients (29 [56%] of 52), compared with HIV-uninfected persons (35 [80%] of 44), were significantly less likely to develop an antibody response (odds ratio, .20; P = .003). Changes in the median geometric mean titer from baseline to day 28 were also significantly lower in HIV-infected patients than in HIV-uninfected persons (75 vs 153; P = .001). Five influenza-like illnesses occurred (2 cases in HIV-infected persons), but none was attributable to the 2009 influenza H1N1 virus. The vaccine was well tolerated in both groups.
CONCLUSIONS
Despite high CD4 cell counts and receipt of antiretroviral medications, HIV-infected adults generated significantly poorer antibody responses, compared with HIV-uninfected persons. Future studies evaluating a 2-dose series or more-immunogenic influenza A (H1N1) vaccines among HIV-infected adults are needed (ClinicalTrials.gov NCT00996970).
背景
目前有关免疫功能低下人群（包括人类免疫缺陷病毒[HIV]感染者）对 2009 年甲型流感（H1N1）疫苗的免疫原性的数据有限。
方法
我们比较了单剂 2009 年甲型流感（H1N1）单价疫苗（A/加利福尼亚/7/2009H1N1 株）在 18-50 岁的 HIV 感染者和 HIV 未感染者中的免疫原性和耐受性。主要终点为接种后 28 天时，接种前抗体滴度≤1:10 的患者的抗体滴度≥1:40，用血凝抑制试验测量。还评估了几何平均滴度、流感样疾病和耐受性。
结果
共评估了 131 名参与者（65 名 HIV 感染者和 66 名 HIV 未感染者），中位年龄为 35 岁（四分位间距，27-42 岁）。HIV 感染者的中位 CD4 细胞计数为 581 个细胞/mm³（四分位间距，476-814 个细胞/mm³），82%的患者正在接受抗逆转录病毒药物治疗。在基线时，35 名患者（27%）的抗体滴度>1:10。与 HIV 未感染者（35 [80%]例）相比，HIV 感染者（52 例中的 29 例[56%]）发生抗体反应的可能性显著降低（比值比，0.20；P=0.003）。与 HIV 未感染者相比，HIV 感染者从基线到第 28 天的中位几何平均滴度变化也明显更低（75 比 153；P=0.001）。发生了 5 例流感样疾病（2 例发生在 HIV 感染者中），但均与 2009 年甲型 H1N1 流感病毒无关。两组患者对疫苗的耐受性均良好。
结论
尽管 CD4 细胞计数较高且正在接受抗逆转录病毒药物治疗，但与 HIV 未感染者相比，HIV 感染者的抗体反应明显较差。需要在 HIV 感染者中进一步研究评估 2 剂系列或更具免疫原性的甲型流感（H1N1）疫苗（ClinicalTrials.gov NCT00996970）。
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