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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

127

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

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

Investigators

  • Study Chair: Myron J Levin
  • Study Chair: Anne A Gershon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACTG 265
  • 10613 (Registry Identifier: DAIDS ES Registry Number)
  • ACTG 265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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