PACTG 1006: EFFECTS OF HAART ON THE RECOVERY OF IMMUNE FUNCTION IN HIV+ CHILDREN

PACTG 1006：HAART 对 HIV 儿童免疫功能恢复的影响

• 批准号: 7605689
• 负责人: William Borkowsky
• 金额: $ 3.73万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605689
• 关键词: Antibody Formation; Antigens; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Candida; Cell Count; Child; Childhood; Computer Retrieval of Information on Scientific Projects Database; Funding; Grant; Growth; HIV; Hepatitis A; Hepatitis A immunization; Highly Active Antiretroviral Therapy; Immune; Immunization; Immunocompromised Host; Immunologics; Institution; Measures; Natural regeneration; Numbers; Phenotype; Plasma; Population; Purpose; RNA; Randomized; Recovery; Recovery of Function; Research; Research Personnel; Resources; Secondary Immunization; Series; Serological; Source; T-Lymphocyte; Testing; Tetanus; Tetanus Toxoid; Tetanus Vaccine; Translating; United States National Institutes of Health; Vaccination; aged; cell mediated immune response; comparative; follow-up; immune function; response; treatment duration

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a randomized, comparative response study with long-term follow-up in HIV-infected children aged 2-17 years who are severely immunocompromised and are initiating highly active antiretroviral therapy (HAART). Subjects must be virologic responders, defined as >0.75 log decrease in plasma HIV RNA copy number 1 month after initiation of HAART. It will consist of approximately 90 subjects in two groups. The purpose of this study is to assess the ability of newly derived CD4 T cells to spontaneously develop lymphoproliferative responses to a recall antigen, tetanus toxoid, or to develop responses after booster vaccinations with tetanus vaccine; to assess the ability to develop protective antibody responses to a T cell-dependent antigen using a primary series of hepatitis A vaccinations.; and to measure the durability of any response beyond the last vaccination. The rationale for this study is that HIV-infected children initiating HAART have shown significant inhibition of HIV growth and significant increases in CD4 T cell counts. It is not known to what extent an increase in CD4 count in this population of children translates to a complete functional immune recovery. HIV-infected children have typically demonstrated poor serological responses to routine childhood immunizations. This study will examine the phenotype of T cells regenerated post-HAART initiation and will assess function by evaluating T cell responses to neoantigens and recall antigens. Cell-mediated immune responses to an environmental antigen (Candida), a recall antigen (tetanus), and a primary immunogen (hepatitis A) will be tested. Studies of immunologic function and recovery will be assessed and correlated with CD4 cells, HAART treatment, and duration of response.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究是一项随机的，比较的反应研究，对2-17岁的HIV感染儿童进行了长期随访，他们受到严重免疫功能低下，并正在启动高度活跃的抗逆转录病毒治疗（HAART）。受试者必须是病毒学反应者，定义为在HAART启动后1个月的血浆HIV RNA拷贝中> 0.75 log降低。它将由两组大约90名受试者组成。这项研究的目的是评估新衍生的CD4 T细胞自发对回忆抗原，破伤风毒素产生淋巴增生反应的能力，或在用破伤风疫苗增强疫苗接种后发展反应； 评估使用一系列乙型肝炎疫苗的主要系列疫苗来开发对T细胞依赖性抗原的保护性抗体反应的能力。并测量除上次疫苗以外的任何反应的耐用性。 这项研究的理由是，引起HAART的HIV感染儿童对CD4 T细胞计数的艾滋病毒生长显着抑制和显着增加。尚不清楚该儿童人群的CD4数量在多大程度上转化为完全的功能免疫恢复。感染HIV的儿童通常表现出对常规儿童免疫的血清学反应不佳。这项研究将检查T细胞的表型再生后haART的开始，并通过评估T细胞对新抗原和召回抗原的反应来评估功能。细胞介导的对环境抗原（念珠菌），召回抗原（TETANUS）和原发性免疫原（乙型肝炎）的免疫反应将进行测试。免疫功能和恢复的研究将与CD4细胞，HAART治疗以及反应持续时间进行评估和相关。