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LC002 is an experimental therapeutic vaccine that was designed to boost the immune response of people infected with HIV. The purpose of this study is to determine the safety and tolerability of and immune response to LC002 in HIV-infected adults who are currently receiving anti-HIV treatment.
The use of highly active antiretroviral therapy (HAART) has dramatically improved the rates of survival, morbidity, and mortality among HIV-infected people throughout the world. However, the costs, long-term toxicity, and problems with adherence associated with HAART regimens make such treatment plans less than optimal for individuals seeking treatment for HIV infection. Also, because viral reservoirs cannot be eradicated, HIV-infected patients must usually be on HAART indefinitely in order to keep their infection under control. While the mechanism is still unclear, the immune system weakens as HIV disease progresses. A therapeutic HIV vaccine given to HIV infected people may help to promote better immune responses. LC002 is a novel HIV therapeutic vaccine containing a DNA plasmid that codes for most of HIV-1's proteins. LC002 is a unique vaccine in that it is given through topical administration; this allows for Langerhans cells (immune cells located under the surface of the skin) to pick up the vaccine and deliver it to the lymph nodes, causing an immune reaction. This study will evaluate the safety, tolerability, and immunogenicity of LC002 in HIV-infected adults currently receiving HAART.
There are three cohorts in this study; cohorts will enroll sequentially. Patients in a given cohort will be randomly assigned to receive either LC002 or placebo.
- In Cohort 1, patients will receive three low-dose vaccinations of LC002 (Arm A) or 3 vaccinations of placebo (Arm B). Vaccinations will be given over two skin sites on the left and right upper back. Patients will receive vaccinations at Weeks 1, 7, and 13.
- In Cohort 2, patients will receive three high-dose vaccinations of LC002 (Arm C) or three vaccinations of placebo (Arm D). Vaccinations will be given over four skin sites on the left and right upper back and left and right upper ventral thigh. Patients will receive vaccinations at Weeks 1, 7, and 13.
- In Cohort 3, patients will receive six high-dose vaccinations of LC002 (Arm E) or six vaccinations of placebo (Arm F). Vaccinations will be given over four skin sites on the left and right upper back and left and right upper ventral thigh. Patients will receive vaccinations at study entry and Weeks 1, 6, 7, 12, and 13.
Prior to receiving the vaccine, the chosen vaccine administration site on the back or thigh will be disinfected and exfoliated. A skin patch will be applied to the site, and the vaccine solution will be placed on the skin underneath the patch with a needleless syringe. Patients will be allowed to remove the skin patch 3 hours post vaccination. For the first and second vaccinations, patients will be required to remain at the clinic for 3 hours post-vaccination so study staff can assess for side effects. If no side effects occur after the first two vaccinations, patients need only stay at the clinic for 30 minutes after receiving later vaccinations.
At the start of the study, patients will be asked to keep a diary and record daily any side effects or skin irritation they may have experienced following vaccination. Patients will need to bring their diaries with them to their next clinic visit. Two days after vaccination, patients will be called at home and asked about any side effects they may have experienced. Patients who experience side effects may be asked to return to the clinic for examination. There will be 13 study visits; they will occur at study entry and Weeks 1, 3, 6, 7, 9, 12, 13, 15, 17, 24, 37, and 61. Study visits will include medication history, a physical exam, and collection of diaries. Blood and urine collection will occur at selected visits. HAART will not be provided by this study.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
LC002 standard vaccination, LC002 high-dose vaccination, LC002 placebo vaccination
University of California, Davis Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:46:58-0400
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