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Safety and Tolerability of a Therapeutic DNA Dendritic Cell Vaccine in HIV-Infected Children, Adolescents, and Young Adults

NCT00614640 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-01

No results posted yet for this study

Summary

The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults. The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DermaVir patch

DNA Vaccine

BIOLOGICAL

Placebo patch

10% dextrose (D-glucose) solution

Sponsors & Collaborators

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Hans M.L. Spiegel, MD · George Washington University School of Medicine

  • Willaim Borkowsky, MD · NYU Langone Health

  • Ram Yogev, MD · CMRC Children's Memorial Hospital

  • Elizabeth McFarland, MD · University of Colorado Health Sciences Ctr.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2013-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00614640 on ClinicalTrials.gov