Immunization of HIV-infected children with varicella vaccine.
M J Levin, A A Gershon, A Weinberg...
https://pubmed.ncbi.nlm.nih.gov/11487761Completed
Phase 1
Age: 12Months - 8Years
All Genders
ID00000837
Phase I/II Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
127
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
Who Can Participate
Age: 12Months - 8Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
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.
Exclusion Criteria
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 25 locations
1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Status Unknown
2
Usc La Nichd Crs
Los Angeles, California, United States, 900331079
Status Unknown
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 900951752
Status Unknown
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 946091809
Status Unknown
5
Children's Hosp. of Orange County
Orange, California, United States
Status Unknown
6
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 920930672
Status Unknown
7
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90509
Status Unknown
8
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 802181088
Status Unknown
9
The Children's Hosp. (Univ. of Colorado, Denver) P7001 CRS
Aurora, Colorado, United States
Status Unknown
10
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
Status Unknown
11
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33311
Status Unknown
12
Chicago Children's CRS
Chicago, Illinois, United States, 606143394
Status Unknown
13
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 212874933
Status Unknown
14
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 29425
Status Unknown
15
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 021155724
Status Unknown
16
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
Status Unknown
17
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
Status Unknown
18
NJ Med. School CRS
Newark, New Jersey, United States, 07103
Status Unknown
19
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Status Unknown
20
Metropolitan Hosp. Ctr.
New York, New York, United States, 10029
Status Unknown
21
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Status Unknown
22
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 146420001
Status Unknown
23
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 117948111
Status Unknown
24
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
Status Unknown
25
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 191044318
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
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