A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
Phase I/II Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children
3 other identifiers
interventional
127
1 country
25
Brief Summary
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.
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
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
Usc La Nichd Crs
Los Angeles, California, 900331079, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 900951752, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 946091809, United States
Children's Hosp. of Orange County
Orange, California, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 920930672, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 90509, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 802181088, 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, 06504, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33311, United States
Chicago Children's CRS
Chicago, Illinois, 606143394, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 212874933, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 29425, 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
NJ Med. School CRS
Newark, New Jersey, 07103, United States
Nyu Ny Nichd Crs
New York, New York, 10016, United States
Metropolitan Hosp. Ctr.
New York, New York, 10029, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 146420001, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 117948111, 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
Related Publications (1)
Levin MJ, Gershon AA, Weinberg A, Blanchard S, Nowak B, Palumbo P, Chan CY; AIDS Clinical Trials Group 265 Team. Immunization of HIV-infected children with varicella vaccine. J Pediatr. 2001 Aug;139(2):305-10. doi: 10.1067/mpd.2001.115972.
PMID: 11487761BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Myron J Levin
- STUDY CHAIR
Anne A Gershon
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- PREVENTION
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
November 1, 2005
Last Updated
October 29, 2021
Record last verified: 2021-10