Status:
COMPLETED
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
12-8 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if it is safe to give Varivax to HIV-positive children and whether it protects children from infection. Varivax is a vaccine against varicella zoster virus (VZV), t...
Detailed Description
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 wit...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00000837
End Date
November 1 2005
Last Update
October 29 2021
Active Locations (25)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
2
Usc La Nichd Crs
Los Angeles, California, United States, 900331079
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 900951752
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 946091809