Search / Trial NCT00000837

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Herpesvirus 3, Human Viral Vaccines Aids Related Complex Vaccines, Attenuated Chickenpox Chickenpox Vaccine

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Myron J Levin

Study Chair

Anne A Gershon

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Oakland, California, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

New York, New York, United States

Long Beach, California, United States

Los Angeles, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

New Haven, Connecticut, United States

New York, New York, United States

Orange, California, United States

San Diego, California, United States

Aurora, Colorado, United States

Fort Lauderdale, Florida, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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