Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
Use of a Live-Attenuated Varicella-Zoster Virus (VZV) Vaccine to Boost Immunity to VZV in HIV-Infected Children Previously Infected With Varicella
3 other identifiers
interventional
60
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedNovember 1, 2021
October 1, 2021
January 17, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
Usc La Nichd Crs
Los Angeles, California, 90033, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 90095-1752, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 905022004, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33311, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 021155724, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
Cooper Univ. Hosp.
Camden, New Jersey, 08103, United States
NJ Med. School CRS
Newark, New Jersey, 07103, United States
Nyu Ny Nichd Crs
New York, New York, 10016, United States
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
New York, New York, 10021, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 146420001, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 191341095, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, 381052794, United States
Vanderbilt Univ. Med. Ctr., Div. of Ped. Infectious Diseases
Nashville, Tennessee, 372322581, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anne Gershon
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2000
First Posted
August 31, 2001
Study Completion
March 1, 2004
Last Updated
November 1, 2021
Record last verified: 2021-10