Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001125
First received: January 17, 2000
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to see if the varicella-zoster virus (VZV) vaccine will be safe and if it can help prevent shingles in HIV-infected children who have already had chickenpox.

VZV is the virus that causes chickenpox. If this virus is reactivated in the body, it can also cause shingles. Shingles is common in children with HIV who have had chickenpox, although it is usually not life-threatening. The VZV vaccine used in this study may be able to prevent HIV-positive children who have had chickenpox from developing shingles.


Condition Intervention Phase
HIV Infections
Chickenpox
Biological: Varicella Virus Vaccine (Live)
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Prevention
Official Title: Use of a Live-Attenuated Varicella-Zoster Virus (VZV) Vaccine to Boost Immunity to VZV in HIV-Infected Children Previously Infected With Varicella

Resource links provided by NLM:


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

Estimated Enrollment: 60
Study Completion Date: March 2004
Detailed Description:

Varicella (chickenpox) results from primary infection with VZV. Varicella, a common and usually benign illness in normal children, is more severe in HIV-infected children and may result in other conditions such as HZ (shingles). HZ is due to reactivation of latent VZV acquired during varicella and is common in HIV-infected children who have had natural varicella. While HZ is not likely to be life-threatening in these children, it does cause considerable morbidity and interferes with quality of life. Use of a live-attenuated VZV vaccine may be able to boost immunity in these children.

Two immunologic cohorts are enrolled. Cohort A includes children with a CD4 cell percentage greater than or equal to 20 percent that has been documented as stable for at least the 6 months prior to the time varicella developed (confirmed by a minimum of 2 tests) and a CD4 cell percentage greater than [AS PER AMENDMENT 10/27/99: or equal to] 15 percent that has been documented as stable for at least the 6 months prior to enrollment (confirmed by a minimum of 2 tests). Cohort B includes children with a CD4 cell percentage greater than or equal to 10 percent and less than 15 percent that has been documented as stable for at least the 6 months prior to the time varicella developed and stable for at least the 6 months prior to enrollment (confirmed by a minimum of 2 tests). [AS PER AMENDMENT 4/20/01: Cohort B includes children who have a CD4 cell percentage less than 15% documented by a minimum of 1 but preferably 2 tests within 1 year of onset of varicella (i.e., within 1 year before to 1 year after varicella) and a CD4 cell percentage greater than or equal to 15% documented by a minimum of 2 tests at the time of enrollment.] A pilot study precedes the full study. [AS PER AMENDMENT 10/27/99: The pilot study for Cohort A precedes the full study for Cohort A and the pilot study for Cohort B. The pilot study for Cohort B precedes the full study for Cohort B.] The pilot study includes 10 children from each cohort who receive live-attenuated VZV at Weeks 0 and 8. If 3 pilot-study patients in a cohort meet a toxicity endpoint related to the vaccine, the dose regimen has failed the safety criteria for that cohort. [AS PER AMENDMENT 10/27/99: If 3 children in the pilot study for Cohort A meet a toxicity endpoint deemed to be related to the vaccine, the dose regimen has failed safety criteria for both cohorts. If 3 children in the pilot phase of Cohort B meet a toxicity endpoint deemed related to the vaccine, the dose regimen has failed the safety criteria for Cohort B.] If, at 12 weeks after immunization, at least 5 pilot-study patients in a cohort respond and the safety profile is deemed adequate, the pilot study extends into a full study with the immunization of an additional 20 patients from that cohort. [AS PER AMENDMENT 10/27/99: If, at Week 12, at least 5 pilot-study patients in Cohort A meet immunologic criteria and the safety profile is deemed adequate, then the full study for Cohort A and the pilot study for Cohort B opens. If the same immunologic and safety criteria are met for the pilot study for Cohort B, then the full study for Cohort B opens.] If either cohort shows an inadequate immunologic response or safety profile, the study team reviews the results to determine if another regimen should be considered. In the full study, patients receive 2 immunizations, at Weeks 0 and 8. Varicella antibody titers and in vitro responder cell frequency (RCF) assays are measured at Weeks 0, 4, 8, 12, 24, 52, 78, and 104. Symptoms, HIV progression, and VZV presence are monitored throughout the study.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Children may be eligible for this study if they:

  • Are 2 to 18 years old (need consent of parent or guardian if under 18).
  • Are HIV-positive.
  • Are VZV-positive.
  • Have a CD4 cell percentage of at least 15 percent at the time of enrollment. (This criterion reflects a change from the original CD4 cell percentage.)
  • Have been receiving stable anti-HIV therapy for at least 3 months, with no plans to change these medications.
  • Had chickenpox at least 6 months prior to study entry.
  • Were at least 1 year old when they had chickenpox.
  • Agree to use a barrier method of birth control (such as a condom) during the study.

Exclusion Criteria

Children will not be eligible for this study if they:

  • Have an active infection within 72 hours of study entry.
  • Have a fever over 101 F within 72 hours of study entry.
  • Were exposed to chickenpox or shingles within 4 weeks prior to study entry.
  • Have ever had shingles.
  • Live with someone who has HIV, or who has a weak immune system, and has never had chickenpox.
  • Have taken certain medications that affect the immune system, such as steroids, within 30 days of study entry.
  • Have taken or are planning to take VZIG or IVIG within 1 year prior to or 2 months after a study vaccination.
  • Are allergic to the vaccine, or to neomycin.
  • Have received or expect to receive another vaccine within 30 days prior to or 30 days after a study vaccination.
  • Have ever received a chickenpox vaccine.
  • Are taking aspirin or expect to use aspirin 6 weeks after a study vaccination.
  • Have taken or plan to take any anti-herpes drugs within 1 week before or 3 weeks after a study vaccination.
  • Have received or plan to receive a blood transfusion within 1 year before or 2 months after a study vaccination.
  • Have certain medical problems that would interfere with the study.
  • Are pregnant or breast-feeding.
  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: NCT00001125

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, 90033
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 905022004
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33311
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
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
Cooper Univ. Hosp.
Camden, New Jersey, United States, 08103
NJ Med. School CRS
Newark, New Jersey, United States, 07103
United States, New York
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Columbia IMPAACT CRS
New York, New York, United States, 10032
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
New York, New York, United States, 10021
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 146420001
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
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 191341095
United States, Tennessee
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 381052794
Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases
Nashville, Tennessee, United States, 372322581
Sponsors and Collaborators
Investigators
Study Chair: Anne Gershon
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001125     History of Changes
Other Study ID Numbers: PACTG 391, 10614, ACTG 391
Study First Received: January 17, 2000
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antibodies, Viral
Chickenpox
Chickenpox Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chickenpox
Herpes Zoster
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 22, 2014