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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00270205 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: LC002 standard vaccination Biological: LC002 high-dose vaccination Biological: LC002 placebo vaccination |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of LC002, a DermaVir Vaccine, HIV-1-Infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART) |
Estimated Enrollment: | 24 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants will receive three low-dose vaccinations of LC002. Vaccinations will be given over two skin sites on the left and right upper back. Participants will receive vaccinations at Weeks 1, 7, and 13.
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Biological: LC002 standard vaccination
0.1 mg DNA/subject, 0.8 mL total administered subcutaneously
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B: Experimental
Participants will receive three vaccinations of LC002 placebo. Vaccinations will be given over two skin sites on the left and right upper back. Participants will receive vaccinations at Weeks 1, 7, and 13.
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Biological: LC002 placebo vaccination
Placebo vaccination administered subcutaneously
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C: Experimental
Participants will receive three high-dose vaccinations of LC002. Vaccinations will be given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participents will receive vaccinations at Weeks 1, 7, and 13.
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Biological: LC002 high-dose vaccination
0.4 mg DNA/subject, 3.2 mL total administered subcutaneously
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D: Experimental
Participants will receive three high-dose vaccinations of LC002 placebo. Vaccinations will be given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants will receive vaccinations at Weeks 1, 7, and 13.
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Biological: LC002 placebo vaccination
Placebo vaccination administered subcutaneously
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E: Experimental
Participants will receive six high-dose vaccinations of LC002. Vaccinations will be given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants will receive vaccinations at study entry and Weeks 1, 6, 7, 12, and 13.
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Biological: LC002 high-dose vaccination
0.4 mg DNA/subject, 3.2 mL total administered subcutaneously
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F: Experimental
Participants will receive six high-dose vaccinations of LC002 placebo. Vaccinations will be given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants will receive vaccinations at study entry and Weeks 1, 6, 7, 12, and 13.
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Biological: LC002 placebo vaccination
Placebo vaccination administered subcutaneously
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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.
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Davis Medical Center | |
Sacramento, California, United States, 95814 | |
United States, Illinois | |
Rush-Presbyterian/St. Lukes (Chicago) | |
Chicago, Illinois, United States, 60612-3806 | |
United States, Ohio | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109-1998 | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106-5083 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213-2582 |
Study Chair: | Richard Pollard, MD | Division of Infectious Diseases, University of California, Davis Medical Center |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5176 |
Study First Received: | December 21, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00270205 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |