A Phase 1/2 interventional study of DermaVir patch and Placebo patch in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Withdrawn. Open to participants aged 6 Years to 23 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment
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.
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.
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Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Exclusion Criteria:
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
Biological: DermaVir patch · Biological: Placebo patch
Four 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84
Biological: DermaVir patch
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
Biological: DermaVir patch
DNA Vaccine
Also known as: LC002
10% dextrose (D-glucose) solution
Also known as: LC002 placebo
Suspected adverse drug reaction (SADR) attributable to vaccine, excluding reaction to patch adhesive
Time frame: Throughout study
Toxicity attributable to the adhesive on patch and not to the vaccine product
Time frame: Throughout study
Decrease in CD4 count by 1/3 of baseline in 2 separate measurements at least 1 month apart
Time frame: Throughout study
Viral load greater than 1000 copies/ml on 2 separate measurements at least 2 weeks apart
Time frame: Throughout study
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)