PHASE I & II STUDY OF VARICELLA VACCINE IN HIV INF CHILDREN

这项试验的假设是，水痘减毒活疫苗对1-8岁的VZV幼稚、无症状或轻度症状的HIV感染儿童是安全的。本研究旨在评价HIV感染儿童接种水痘疫苗的安全性和免疫原性。这项研究将监测接种水痘减毒活疫苗后的短期局部和全身反应，并监测接种水痘疫苗的儿童感染艾滋病毒的临床和免疫学进展。针对水痘的免疫接种应保护感染艾滋病毒的儿童免受自然水痘感染引起的严重疾病和危及生命的并发症的风险。目前使用VZIG治疗的被动预防措施不是最优的，因为无法及时通知儿童的照顾者暴露，以及需要为儿童一生中的多次暴露中的每一次重复使用VZIG。管理水痘暴露已成为向艾滋病毒感染儿童的诊所人群提供护理的最耗时、最昂贵和后勤困难的方面之一。研究人群包括年龄在12至48个月之间、无症状(P-1)或轻度症状(P-2)、围产期获得性艾滋病毒-1感染的儿童。此外，将登记一组由12-48个月大、患有P-1或轻度P-2围产期获得性HIV-1感染且曾感染野生型水痘的儿童组成的对照组。共有56名受试者(36名试验组和20名对照组)入选。

The hypothesis of this trial is that live-attenuated varicella vaccine will be safe in VZV-naive, asymptomatic or mildly symptomatic HIV-infected children 1-8 years of age. The aim of this study is to evaluate the safety and immunogenicity of varicella vaccine in HIV infected children. The study will monitor the short-term local and systemic reactions following administration of live-attenuated varicella vaccine, and monitor the clinical and immunologic progression of HIV in children who have received varicella vaccine. Immunization against varicella should protect HIV-infected children from the risk of severe disease and life-threatening complications due to natural varicella infection. Current passive prophylaxis measures with VZIG therapy are suboptimal, because of the unpredictability of timely notification of the child's caretaker of exposures, as well as the need for repeated VZIG administration for each of the many exposures during the child's lifetime. Managing chickenpox exposures has become one of the most time-consuming, costly, and logistically difficult aspects of providing care to a clinic population of HIV-infected children. The study population is comprised of children between the ages of 12 and 48 months, with asymptomatic (P-1) or mildly symptomatic (P-2), perinatally-acquired HIV-1 infection,. In addition, a control group consisting of children 12-48 months old, with P-1 or mild P-2 perinatally-acquired HIV-1 infection who have had wild-type varicella infection will be registered. A total of 56 (36 treatment and 20 control) subjects will be enrolled.