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首页> 外文期刊>AIDS >Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: A phase I/II, randomized trial
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Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: A phase I/II, randomized trial

机译：M72 / AS01候选成年人的安全性和免疫原性艾滋病毒感染的成年人组合抗逆转录病毒治疗：I / II期，随机试验

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摘要

OBJECTIVE:: Tuberculosis (TB) is highly prevalent among HIV-infected people, including those receiving combination antiretroviral therapy (cART), necessitating a well tolerated and efficacious TB vaccine for these populations. We evaluated the safety and immunogenicity of the candidate TB vaccine M72/AS01 in adults with well controlled HIV infection on cART. DESIGN:: A randomized, observer-blind, controlled trial (NCT00707967). METHODS:: HIV-infected adults on cART in Switzerland were randomized 3:1:1 to receive two doses, 1 month apart, of M72/AS01, AS01 or 0.9% physiological saline (N=22, N=8 and N=7, respectively) and were followed up to 6 months postdose 2 (D210). Individuals with CD4 cell counts below 200cells/μl were excluded. Adverse events (AEs) including HIV-specific and laboratory safety parameters were recorded. Cell-mediated (ICS) and humoral (ELISA) responses were evaluated before vaccination, 1 month after each dose (D30, D60) and D210. RESULTS:: Thirty-seven individuals [interquartile range (IQR) CD4 cell counts at screening: 438-872cells/μl; undetectable HIV-1 viremia] were enrolled; 73% of individuals reported previous BCG vaccination, 97.3% tested negative for the QuantiFERON-TB assay. For M72/AS01 recipients, no vaccine-related serious AEs or cART-regimen adjustments were recorded, and there were no clinically relevant effects on laboratory safety parameters, HIV-1 viral loads or CD4 cell counts. M72/AS01 was immunogenic, inducing persistent and polyfunctional M72-specific CD4 T-cell responses [medians 0.70% (IQR 0.37-1.07) at D60] and 0.42% (0.24-0.61) at D210, predominantly CD40LIL-2TNF-α, CD40LIL-2 and CD40LIL-2TNF-αIFN- γ]. All M72/AS01 vaccines were seropositive for anti-M72 IgG after second vaccination until study end. CONCLUSION:: M72/AS01 was clinically well tolerated and immunogenic in this population, supporting further clinical evaluation in HIV-infected individuals in TB-endemic settings.
机译：目的::结核病（TB）在艾滋病毒感染的人群中普遍普遍，包括接受组合抗逆转录病毒治疗（推车）的人，需要为这些群体提供良好的耐受性和有效的TB疫苗。我们评估了在随着Cart上有良好控制的HIV感染的成人中候选TB疫苗M72 / AS01的安全性和免疫原性。设计::随机，观察者盲，受控试验（NCT00707967）。方法::瑞士购物车的艾滋病毒感染的成人随机3：1：1接收两剂，1个月，M72 / AS01，AS01或0.9％的生理盐水（n = 22，n = 8和n = 7分别为6个月后，持续2（D210）。不包括低于200cells /μl的CD4细胞计数的个体。记录了包括HIV特异性和实验室安全参数的不良事件（AES）。在疫苗接种前评估细胞介导的（ICS）和体液（ELISA）反应，每次剂量（D30，D60）和D210后1个月。结果::三十七个人[屏幕间距（IQR）CD4细胞计数：438-872cells /μl;未定例的HIV-1病毒血症是注册; 73％的个体报告以前的BCG疫苗接种，97.3％对Qualliferon-TB测定的测试负面。对于M72 / AS01受体，记录没有疫苗相关的严重AES或购物车方案调整，并且对实验室安全参数没有临床相关影响，HIV-1病毒载量或CD4细胞计数。 M72 / AS01是免疫原性的，诱导持续和多官能M72特异性CD4 T细胞[中位数0.70％（IQR 0.37-1.07）在D60]和0.42％（0.24-0.61）的D210，主要是CD40LIL-2TNF-α，CD40LIL -2和CD40LIL-2TNF-αIFN-γ]。所有M72 / AS01疫苗均为抗M72 IgG血清阳性，第二次疫苗接种后直至研究结束。结论:: M72 / AS01在该群体中临床良好耐受性和免疫原性，在TB-didem环境中支持艾滋病毒感染个体的进一步临床评价。

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  • 来源
    《AIDS》 |2014年第12期|共13页
  • 作者

    ThacherE.G.; CavassiniM.; AudranR.; ThierryA.-C.; BollaertsA.; CohenJ.; DemoitiéM.-A.; EjiguD.; MettensP.; MorisP.; Ofori-AnyinamO.; SpertiniF.;

  • 作者单位

    Division of Immunology and Allergy Centre Hospitalier Universitaire Vaudois (CHUVBH19) Rue du;

    Service of Infectious Diseases Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne;

    Division of Immunology and Allergy Centre Hospitalier Universitaire Vaudois (CHUVBH19) Rue du;

    Division of Immunology and Allergy Centre Hospitalier Universitaire Vaudois (CHUVBH19) Rue du;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    GlaxoSmithKline Vaccines Rixensart Belgium;

    Division of Immunology and Allergy Centre Hospitalier Universitaire Vaudois (CHUVBH19) Rue du;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 传染病;
  • 关键词

    AS01; HIV positive on antiretroviral therapy; immunogenicity; M72; tuberculosis vaccine;

    机译：AS01;艾滋病毒阳性抗逆转录病毒治疗;免疫原性;M72;结核病疫苗;

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