IMPAACT P1049
Status:Withdrawn
Phase:I/II
Principal Investigator(s):Hans M.L. Spiegel, MD, Willaim Borkowsky, MD, Ram Yogev, MD & Elizabeth McFarland, MD
Objective: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.
Prevention Option(s):Cure, Therapeutic Vaccines
Study Design:Non-randomized, Open label
Arms and Assigned Interventions
DescriptionDermaVir patch, DNA Vaccine (Other Name: LC002)
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
Mode of Delivery
ARMsExperimental
DescriptionDermaVir patch, DNA Vaccine (Other Name: LC002)
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
Mode of Delivery
ARMsExperimental
DescriptionDermaVir patch, DNA Vaccine (Other Name: LC002)
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
Mode of Delivery
ARMsExperimental
Official Code:
NCT00614640
Trial Sponsors:
NIAID
Start Date
End Date
February 29, 2008
none
Enrollment:32
Age range:
6 Years ↔
23 Years
Population:Cisgender Men, Cisgender Women, People Living with HIV