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

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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.