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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000837

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

127

Expected to finish

2005-11-01

Last updated by the study team

2021-10-29

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

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
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• Children's Hosp. of Orange County — Orange, California, United States
• UCSD Mother-Child-Adolescent Program CRS — San Diego, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• The Children's Hosp. (Univ. of Colorado, Denver) P7001 CRS — Aurora, Colorado, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, 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
• NJ Med. School CRS — Newark, New Jersey, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Metropolitan Hosp. Ctr. — 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 Stony Brook NICHD CRS — Stony Brook, 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

Full record on ClinicalTrials.gov

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