A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Primary varicella infection, or chickenpox, can be devastating to HIV-infected children because complications occur at higher rates in immunocompromised hosts. Current passive prophylaxis measures with varicella-zoster immune globulin are suboptimal because administration must be repeated for each exposure during the child's lifetime and timely notification of exposure is not always possible. Since Varivax has been licensed for routine vaccination of healthy individuals, it must be determined whether this vaccine can be safely administered to HIV-infected children.

Thirty-six children who ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Children may be eligible for this study if they:
• • Are HIV-positive with no symptoms or moderate symptoms.
• • Are between 1 and 8 years old (consent of parent or guardian required).
• • Have had a CD4 cell count greater than 200 for the past 3 months. If a child had a lower CD4 count before this time, then he/she must have been on stable anti-HIV therapy for the past 3 months.
• • Exclusion Criteria
• Children will not be eligible for this study if they:
• • Have had an infection or a fever of 101 F or higher in the past 3 days.
• • Have had chickenpox or shingles. (This study has been changed. Children who had VZV infections were eligible originally.)
• • Have been exposed to chickenpox or shingles in the past 4 weeks.
• • Live with someone who is HIV-positive or who has a lowered immune system.
• • Have certain serious diseases including tuberculosis or a disease of the immune system (other than HIV infection).
• • Are allergic to any part of the chickenpox vaccine, including neomycin.
• • Have recently had certain treatments or might be taking certain treatments during the study such as aspirin, VZIG, IVIG, other vaccines, steroids, anti-herpes medications, blood products, or drugs that might interfere with the immune system.