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

Completed · Phase 1

Conditions studied: HIV Infections, Chickenpox

In brief

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.

Key facts

Study ID

NCT00001125

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

2004-03-01

Last updated by the study team

2021-11-01

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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.
• Are pregnant or breast-feeding.

Where it is running

• 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

Full record on ClinicalTrials.gov

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