Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals
Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals
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DOI：
10.1097/qad.0b013e32833c6d5c
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发表时间：
2010-09-10
期刊：
影响因子：
3.8
通讯作者：
Sullivan, Kathleen
中科院分区：
文献类型：
--
作者：
Tebas, Pablo;Frank, Ian;Sullivan, Kathleen
目的：评价2009年H1N1流感疫苗在hiv阳性人群中的安全性和免疫原性。设计：单臂研究。地点：美国宾夕法尼亚州费城宾夕法尼亚大学附属医院诊所。参与者：有H1N1疫苗接种指征的hiv感染成人。干预措施：单次肌肉注射单价、无佐剂、灭活、分裂病毒H1N1疫苗15 μ g。主要结果：免疫原性、安全性和耐受性。结果：共纳入120名参与者，71%为男性，68%为非洲裔美国人，中位年龄为46岁。除一人外，他们都在接受抗逆转录病毒治疗，目前CD4细胞计数的中位数为502个细胞/ μ l， CD4细胞计数的最低点为132个细胞/ μ l。92%的参与者的HIV RNA水平低于400拷贝/ml。所有参与者都完成了为期3周的随访。120名参与者中有30名（25%）在基线时抗体血凝抑制试验滴度等于或大于1:40。在没有既往接触证据的参与者中，只有61%的人在研究的第三周产生了保护效价。无应答者的当前和最低点CD4细胞计数低于应答者。在基线水平可检测到HIV病毒载量的9名参与者中，只有4名产生了保护性抗体滴度。年龄和种族不是对疫苗反应的预测因子。这种疫苗耐受性良好。结论：这些结果表明，在没有预先存在H1N1免疫的控制良好的hiv感染者中，只有60%的人在免疫后产生保护性抗体滴度。需要替代疫苗、剂量、佐剂或时间表策略来实现对这一脆弱人群的有效免疫。(C) 2010年Wolters Kluwer Health垂直条Lippincott Williams & Wilkins
Objective: To evaluate the safety and immunogenicity of the H1N1 2009 vaccine in HIV-positive individuals.Design: A single-arm study.Setting: Clinic at the Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.Participants: HIV-infected adults with an indication for H1N1 vaccination.Intervention: Single intramuscular 15 mu g dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine.Main outcomes: Immunogenicity, safety and tolerability.Results: A total of 120 participants were enrolled, 71% men, 68% African- American, with median age of 46 years. All of them but one were on antiretroviral treatment, with a median current CD4 cell counts of 502 cells/mu l, and a nadir CD4 cell counts of 132 cells/mu l. The HIV RNA level was below 400 copies/ml in 92% of participants. All participants completed the 3 weeks of follow-up. Thirty of the 120 (25%) participants had antibody hemagglutination-inhibition assay titers equal or greater than 1 : 40 at baseline. Among participants without evidence of previous exposure, only 61% develop protective titers by week 3 of the study. Nonresponders had lower current and nadir CD4 cell counts than responders. Only four of nine participants with detectable HIV viral load at baseline developed protective antibody titers. Age and race were not predictors of the response to the vaccine. The vaccine was well tolerated.Conclusion: These results suggest that only 60% of well controlled HIV-infected individuals without preexisting immunity to H1N1 develop protective antibody titers after immunization. Alternative vaccines, dosing, adjuvants or schedule strategies are needed to achieve effective immunization of this vulnerable population. (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins