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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000837

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

127

Enrollment

Locations

5.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: Varicella Virus Vaccine (Live)	Phase 1

Detailed Description

Primary varicella infection, or chickenpox, can be devastating to HIV-infected children because complications occur at higher rates in immunocompromised hosts. Current passive prophylaxis measures with varicella-zoster immune globulin are suboptimal because administration must be repeated for each exposure during the child's lifetime and timely notification of exposure is not always possible. Since Varivax has been licensed for routine vaccination of healthy individuals, it must be determined whether this vaccine can be safely administered to HIV-infected children.

Thirty-six children who are varicella zoster virus (VZV)-naive (treatment group) receive Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of wild-type varicella exposure within the past year (control group) receive no study treatment. All patients are either asymptomatic or mildly symptomatic for HIV infection. Patients make 12-14 visits to the clinic. [AS PER AMENDMENT 9/9/99: This study has been reorganized into two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort, accrual has been completed with 40 patients in Treatment Group I and 19 in the control group. This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease. The symptomatic cohort includes Treatment Groups II and III, each with 30 patients. The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued. Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles, the remaining 20 Group II and the first 10 Group III patients are enrolled. The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients.]

Study Design

Study Type:

Interventional

Primary Purpose:

Prevention

Official Title:

Phase I/II Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children

Actual Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California	United States	90801
2	Usc La Nichd Crs	Los Angeles	California	United States	900331079
3	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California	United States	900951752
4	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California	United States	946091809
5	Children's Hosp. of Orange County	Orange	California	United States
6	UCSD Mother-Child-Adolescent Program CRS	San Diego	California	United States	920930672
7	Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases	Torrance	California	United States	90509
8	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado	United States	802181088
9	The Children's Hosp. (Univ. of Colorado, Denver) P7001 CRS	Aurora	Colorado	United States
10	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut	United States	06504
11	South Florida CDTC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida	United States	33311
12	Chicago Children's CRS	Chicago	Illinois	United States	606143394
13	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland	United States	212874933
14	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland	United States	29425
15	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts	United States	021155724
16	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts	United States	02118
17	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts	United States	01199
18	NJ Med. School CRS	Newark	New Jersey	United States	07103
19	Nyu Ny Nichd Crs	New York	New York	United States	10016
20	Metropolitan Hosp. Ctr.	New York	New York	United States	10029
21	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States
22	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York	United States	146420001
23	SUNY Stony Brook NICHD CRS	Stony Brook	New York	United States	117948111
24	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York	United States	13210
25	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania	United States	191044318