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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000837 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: Varicella Virus Vaccine (Live) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Safety Study |
| Official Title: | Phase I/II Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children |
| Estimated Enrollment: | 127 |
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.]
Eligibility| Ages Eligible for Study: | 12 Months to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham - Pediatric | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| Children's Hosp of Los Angeles/UCLA Med Ctr | |
| Los Angeles, California, United States, 900276016 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Long Beach Memorial (Pediatric) | |
| Long Beach, California, United States, 90801 | |
| UCLA Med Ctr / Pediatrics | |
| Los Angeles, California, United States, 90095 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90509 | |
| United States, Colorado | |
| Children's Hosp of Denver | |
| Denver, Colorado, United States, 802181088 | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale Univ Med School | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| Children's Hosp of Washington DC | |
| Washington, District of Columbia, United States, 200102916 | |
| United States, Florida | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33311 | |
| Sacred Heart Children's Hosp / CMS of Florida | |
| Pensacola, Florida, United States, 32503 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| United States, Louisiana | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore / Univ Med Ctr | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins Hosp - Pediatric | |
| Baltimore, Maryland, United States, 212874933 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Boston City Hosp / Pediatrics | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med School | |
| Worcester, Massachusetts, United States, 016550001 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| UMDNJ - Robert Wood Johnson Med School / Pediatrics | |
| New Brunswick, New Jersey, United States, 089030019 | |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| SUNY - Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| Metropolitan Hosp Ctr | |
| New York, New York, United States, 10029 | |
| Schneider Children's Hosp | |
| New Hyde Park, New York, United States, 11040 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| North Shore Univ Hosp | |
| Great Neck, New York, United States, 11021 | |
| Children's Hosp at Albany Med Ctr | |
| Albany, New York, United States, 12208 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10457 | |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 146420001 | |
| New York Hosp - Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| Montefiore Medical / AECOM | |
| Bronx, New York, United States, 19461 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Ohio | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| United States, Pennsylvania | |
| Children's Hosp of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 191044318 | |
| United States, South Carolina | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 294253312 | |
| United States, Washington | |
| Children's Hospital & Medical Center / Seattle ACTU | |
| Seattle, Washington, United States, 981050371 | |
| Study Chair: | Myron J Levin | |
| Study Chair: | Anne A Gershon |
More Information
| Study ID Numbers: | ACTG 265, PACTG 265 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00000837 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Herpesvirus 3, Human Viral Vaccines AIDS-Related Complex |
Vaccines, Attenuated Chickenpox Chickenpox Vaccine |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Chickenpox Infection Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |