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A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000837
First received: November 2, 1999
Last updated: May 31, 2013
Last verified: May 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Prevention
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
Study Completion Date: November 2005
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000837

Locations
United States, California
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 900951752
Usc La Nichd Crs
Los Angeles, California, United States, 900331079
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 946091809
Children's Hosp. of Orange County
Orange, California, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 920930672
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90509
United States, Colorado
The Children's Hosp. (Univ. of Colorado, Denver) P7001 CRS
Aurora, Colorado, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 802181088
United States, Connecticut
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33311
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 606143394
United States, Maryland
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 212874933
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 29425
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 021155724
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
United States, New Jersey
NJ Med. School CRS
Newark, New Jersey, United States, 07103
United States, New York
Metropolitan Hosp. Ctr.
New York, New York, United States, 10029
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 146420001
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 117948111
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
United States, Pennsylvania
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 191044318
Sponsors and Collaborators
Investigators
Study Chair: Myron J Levin
Study Chair: Anne A Gershon
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000837     History of Changes
Other Study ID Numbers: PACTG 265, 10613, ACTG 265
Study First Received: November 2, 1999
Last Updated: May 31, 2013
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014