SAFETY AND IMMUNOGENICITY OF OKA/MERCK VARICELLA VIRUS VACCINE IN CHILDREN W/HIV

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。尽管水痘-带状疱疹病毒通常被认为是儿童的“常规”疾病，但它是美国儿童接种疫苗可预防的死亡的主要原因。即使在健康的儿童中，水痘也会导致严重的并发症，包括继发性细菌感染、肺炎、中枢神经系统和眼部疾病。在感染艾滋病毒的儿童中，水痘-带状疱疹病毒可能比健康儿童更容易引起严重并发症(2、3、4)。洛杉矶儿童医院临床免疫学和过敏科的经验是，尽管进行了密集的预防工作，但我们的大多数艾滋病毒感染患者可能会接触到野生型VZV并感染。使用水痘-带状疱疹免疫球蛋白(VZIG)进行被动预防并不是最理想的，因为在患者的一生中，每次接触都必须重复给药，而且接触的及时通知并不总是可能的。最近对我们计划中的三名患者的经验进一步表明，正在进行的IVIG治疗对这一患者群体没有保护作用(5)。Varivax-自1995年在美国获得许可，目前推荐给所有健康的儿童。该疫苗已经在免疫系统正常的儿童中进行了广泛的研究，并在对照的临床试验中被证明在预防或改变疾病方面非常有效(6、7、8、9、10)。对没有免疫抑制证据的无症状或轻微症状的艾滋病毒感染儿童(CDC N1或A1类)进行免疫的有限数据表明，该疫苗是安全、免疫原性和有效的。然而，目前它还没有被批准用于T细胞低于正常水平的HIV阳性儿童或每月接受IVIG注射的儿童。因此，我们建议研究在不符合CDC N1或A1类标准的HIV感染儿童中使用Varivax-in的安全性和免疫原性。

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. Although commonly viewed as "routine" childhood illness, varicella-zoster virus is the leading cause of vaccine preventable deaths in children in United States (1). Even in healthy children, chicken pox can cause serious complications including secondary bacterial infections, pneumonia, and central nervous system and ocular diseases. In HIV-infected children, varicella-zoster virus may cause serious complications more often than in healthy children (2, 3, 4). It has been the experience in the Division of Clinical Immunology and Allergy at Childrens Hospital Los Angeles that despite intense preventive efforts, exposure to and infection with wild-type VZV is likely to occur in a majority of our HIV-infected patients. Passive prophylaxis with varicella-zoster immunoglobulins (VZIG) are suboptimal because administration must be repeated for each exposure in patient's lifetime and timely notification of exposure is not always possible. Recent experience with three patients in our program further demonstrated that ongoing treatment with IVIG is not protective in this patient population (5). Varivax- has been licensed in United States since 1995 and is currently recommended for all healthy children. The vaccine has been extensively studied in children with normal immune system and has shown to be highly effective in preventing or modifying disease in controlled, clinical trials (6, 7, 8, 9, 10). Limited data on immunization of asymptomatic or mildly symptomatic HIV-infected children without evidence of immune suppression (CDC class N1 or A1) indicated that the vaccine is safe, immunogenic, and effective (11). However, it is currently not approved for use in HIV positive children who have lower than normal T-cells or who are receiving monthly IVIG infusions. Thus, we propose to study the safety and immunogenicity of Varivax- in HIV-infected children who do not meet the criteria for CDC class N1 or A1.