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

第一阶段

• 批准号: 6264034
• 负责人: ANDREA JENAY RUFF
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264034
• 关键词: HIV infections; Herpesviridae vaccine; antibody titering; attenuated microorganism; chickenpox; clinical research; clinical trial phase I; helper T lymphocyte; human immunodeficiency virus 1; human subject; human therapy evaluation; immunization; leukocyte count; pediatric AIDS; preschool child (1-5); varicella zoster virus

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.

本试验的假设是，水痘减毒活疫苗对1-8岁的VZV初治、无症状或轻度症状的HIV感染儿童是安全的。 本研究的目的是评价水痘疫苗在HIV感染儿童中的安全性和免疫原性。 该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中HIV的临床和免疫学进展。水痘免疫接种应保护感染艾滋病毒的儿童免受自然水痘感染导致的严重疾病和危及生命的并发症的风险。 目前使用VZIG疗法的被动预防措施是次优的，因为及时通知儿童的看护人暴露的不可预测性，以及在儿童一生中多次暴露中的每一次都需要重复VZIG给药。 管理水痘暴露已成为向HIV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个月之间的无症状（P-1）或轻度症状（P-2）的围产期获得性HIV-1感染儿童。 此外，还将登记一个对照组，包括12-48个月大、患有P-1或轻度P-2围产期获得性HIV-1感染且患有野生型水痘感染的儿童。 共入组56例（36例治疗组和20例对照组）受试者。