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A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
This study has been completed.
First Received: November 2, 1999   Last Updated: October 5, 2007   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 127
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.]

  Eligibility

Ages Eligible for Study:   12 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000837

  Hide Study Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Myron J Levin
Study Chair: Anne A Gershon
  More Information

Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Herpesvirus 3, Human
Viral Vaccines
AIDS-Related Complex
Vaccines, Attenuated
Chickenpox
Chickenpox Vaccine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009