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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00614640 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: DermaVir patch Biological: Placebo patch |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | A Phase I/II Study of the Safety, Tolerability, and Immunogenicity of a Topical Therapeutic DNA Dendritic Cell Vaccine (DermaVir Patch) in Children, Adolescents, and Young Adults With HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART) |
Estimated Enrollment: | 32 |
Study Start Date: | September 2009 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One 0.8 ml vaccine-containing patch and 1 placebo patch placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84
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Biological: DermaVir patch
DNA Vaccine
Biological: Placebo patch
10% dextrose (D-glucose) solution
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2: Experimental
Four 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84
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Biological: DermaVir patch
DNA Vaccine
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3: Experimental
Four 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 7, 42, 49, 84, and 91
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Biological: DermaVir patch
DNA Vaccine
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The introduction of highly active antiretroviral therapy (HAART) for children and adolescents has resulted in improved control of viral replication for prolonged periods of time and a significant reduction in morbidity. However, when compared to the responses seen in adults, children have overall inferior virologic responses. The therapeutic 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.
This study will last up to 61 weeks (up to 13 weeks of treatment with an additional 48 weeks for follow-up). Participants will be randomly stratified according to age and dosage. Group 1 will consist of 8 adolescents and young adults (between ages 13 and 23) and 8 children (between ages 6 and 12). Group 1 participants will have one 0.8 ml DermaVir patch and one control patch applied on Days 0, 42, and 84. Group 2 will consist of 4 adolescents and young adults and 4 children. Group 2 participants will have four 0.8 ml DermaVir patches applied on Days 0, 42, and 84. Group 3 will consist of 4 adolescents and young adults and 4 children. Group 3 participants will have four 0.8 ml DermaVir patches applied on Days 0, 7, 42, 49, 84, and 91.
There will be 14 study visits for each participant. They will occur at screening and Days 0, 7, 21, 42, 49, 63, 84, 91, 105, 126, 168, 259, and 427. Screening will occur up to 30 days before the first vaccination (Day 0). Medical history and physical exam will occur at all visits. Blood and urine collection and an adherence assessment will occur at most visits. A urine pregnancy test will occur for females at most visits.
Ages Eligible for Study: | 6 Years to 23 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Hans M.L. Spiegel, MD | George Washington University School of Medicine |
Study Chair: | Willaim Borkowsky, MD | New York University School of Medicine |
Study Chair: | Ram Yogev, MD | CMRC Children's Memorial Hospital |
Study Chair: | Elizabeth McFarland, MD | University of Colorado Health Sciences Ctr. |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | IMPAACT P1049, PACTG 1049 |
Study First Received: | February 11, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00614640 |
Health Authority: | United States: Food and Drug Administration |
HAART Therapeutic vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |