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. ABSTRACT 265 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 the clinical and immunologic progression of HIV in children who have received varicella vaccine. The study population is composed of VZV-naive children between 1 and 8 years of age who fall into one of three treatment groups: (1) asymptomatic or mildly symptomatic cohort: Group I (accrual complete); (2) symptomatic cohort: Group II: category B1, A2, N2 or B2 subjects; (3) symptomatic cohort: Group III: subjects previously classified at immunologic stage 3, but are at category A1 or N1 at entry and for three months prior to entry. Additionally, subjects must have been on stable antiretroviral therapy for at least three months prior to entry, (regimen must include at least one PI and > 2 RTIs). The study population also includes a control group consisting of asymptomatic or mildly symptomatic group consisting of children with category N1 or A1 perinatally-acquired HIV-1 infection who have had wild-type varicella infection in the past 12 months (accrual complete). A total of 127 (asymptomatic cohort: Group I n=48; control n=19 [accrual complete]; symptomatic cohort: Group II n=30; Group III n=30) subjects will be enrolled. The study has enrolled 129 patients nationally. We have enrolled 3 patients in this study.
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