Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox

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

Keywords

ClinConnect Summary

Varicella (chickenpox) results from primary infection with VZV. Varicella, a common and usually benign illness in normal children, is more severe in HIV-infected children and may result in other conditions such as HZ (shingles). HZ is due to reactivation of latent VZV acquired during varicella and is common in HIV-infected children who have had natural varicella. While HZ is not likely to be life-threatening in these children, it does cause considerable morbidity and interferes with quality of life. Use of a live-attenuated VZV vaccine may be able to boost immunity in these children.

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Eligibility criteria

• • Inclusion Criteria
• Children may be eligible for this study if they:
• • Are 2 to 18 years old (need consent of parent or guardian if under 18).
• • Are HIV-positive.
• • Are VZV-positive.
• • Have a CD4 cell percentage of at least 15 percent at the time of enrollment. (This criterion reflects a change from the original CD4 cell percentage.)
• • Have been receiving stable anti-HIV therapy for at least 3 months, with no plans to change these medications.
• • Had chickenpox at least 6 months prior to study entry.
• • Were at least 1 year old when they had chickenpox.
• • Agree to use a barrier method of birth control (such as a condom) during the study.
• • Exclusion Criteria
• Children will not be eligible for this study if they:
• • Have an active infection within 72 hours of study entry.
• • Have a fever over 101 F within 72 hours of study entry.
• • Were exposed to chickenpox or shingles within 4 weeks prior to study entry.
• • Have ever had shingles.
• • Live with someone who has HIV, or who has a weak immune system, and has never had chickenpox.
• • Have taken certain medications that affect the immune system, such as steroids, within 30 days of study entry.
• • Have taken or are planning to take VZIG or IVIG within 1 year prior to or 2 months after a study vaccination.
• • Are allergic to the vaccine, or to neomycin.
• • Have received or expect to receive another vaccine within 30 days prior to or 30 days after a study vaccination.
• • Have ever received a chickenpox vaccine.
• • Are taking aspirin or expect to use aspirin 6 weeks after a study vaccination.
• • Have taken or plan to take any anti-herpes drugs within 1 week before or 3 weeks after a study vaccination.
• • Have received or plan to receive a blood transfusion within 1 year before or 2 months after a study vaccination.
• • Have certain medical problems that would interfere with the study.
• • Are pregnant or breast-feeding.

Trial Officials