Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
NCT ID: NCT00001125
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2004-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PREVENTION
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Varicella Virus Vaccine (Live)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
2 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Gershon
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, 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
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 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
Cooper Univ. Hosp.
Camden, New Jersey, United States
NJ Med. School CRS
Newark, New Jersey, United States
Nyu Ny Nichd Crs
New York, New York, United States
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
New York, New York, United States
Columbia IMPAACT CRS
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 Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10614
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 391
Identifier Type: -
Identifier Source: secondary_id
PACTG 391
Identifier Type: -
Identifier Source: org_study_id