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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of a Live-Attenuated Varicella-Zoster Virus (VZV) Vaccine to Boost Immunity to VZV in HIV-Infected Children Previously Infected With Varicella

Brief Summary:

The purpose of this study is to see if the varicella-zoster virus (VZV) vaccine will be safe and if it can help prevent shingles in HIV-infected children who have already had chickenpox.

VZV is the virus that causes chickenpox. If this virus is reactivated in the body, it can also cause shingles. Shingles is common in children with HIV who have had chickenpox, although it is usually not life-threatening. The VZV vaccine used in this study may be able to prevent HIV-positive children who have had chickenpox from developing shingles.

Detailed 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.

Two immunologic cohorts are enrolled. Cohort A includes children with a CD4 cell percentage greater than or equal to 20 percent that has been documented as stable for at least the 6 months prior to the time varicella developed (confirmed by a minimum of 2 tests) and a CD4 cell percentage greater than [AS PER AMENDMENT 10/27/99: or equal to] 15 percent that has been documented as stable for at least the 6 months prior to enrollment (confirmed by a minimum of 2 tests). Cohort B includes children with a CD4 cell percentage greater than or equal to 10 percent and less than 15 percent that has been documented as stable for at least the 6 months prior to the time varicella developed and stable for at least the 6 months prior to enrollment (confirmed by a minimum of 2 tests). [AS PER AMENDMENT 4/20/01: Cohort B includes children who have a CD4 cell percentage less than 15% documented by a minimum of 1 but preferably 2 tests within 1 year of onset of varicella (i.e., within 1 year before to 1 year after varicella) and a CD4 cell percentage greater than or equal to 15% documented by a minimum of 2 tests at the time of enrollment.] A pilot study precedes the full study. [AS PER AMENDMENT 10/27/99: The pilot study for Cohort A precedes the full study for Cohort A and the pilot study for Cohort B. The pi
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: January 17, 2000
Date Started:
Date Completion:
Last Updated: October 28, 2014
Last Verified: October 2014