A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00000837
- 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), the virus that causes chickenpox (varicella) and shingles (zoster).
VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine that has been approved for use in healthy children. More research is needed to find out how this vaccine will affect HIV-infected children.
- 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 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 are varicella zoster virus (VZV)-naive (treatment group) receive Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of wild-type varicella exposure within the past year (control group) receive no study treatment. All patients are either asymptomatic or mildly symptomatic for HIV infection. Patients make 12-14 visits to the clinic. \[AS PER AMENDMENT 9/9/99: This study has been reorganized into two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort, accrual has been completed with 40 patients in Treatment Group I and 19 in the control group. This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease. The symptomatic cohort includes Treatment Groups II and III, each with 30 patients. The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued. Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles, the remaining 20 Group II and the first 10 Group III patients are enrolled. The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Children's Hosp. of Orange County
🇺🇸Orange, California, United States
UCSD Mother-Child-Adolescent Program CRS
🇺🇸San Diego, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
South Florida CDTC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
Metropolitan Hosp. Ctr.
🇺🇸New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
The Children's Hosp. (Univ. of Colorado, Denver) P7001 CRS
🇺🇸Aurora, Colorado, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States