Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00270205
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2005-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of LC002, a DermaVir Vaccine, in HIV-1-Infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV treatment.
Detailed Description:
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 people 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 evaluated the safety, tolerability, and immunogenicity of LC002 in HIV-infected adults currently receiving HAART.
There were three cohorts in this study which were enrolled sequentially. Participants in a given cohort were randomly assigned to receive either LC002 (6 participants) or placebo (2 participants).
* In Cohort 1, participants received three separate low-dose vaccinations of LC002 (Arm A: 0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites of 80 cm\^2 each, 0.4 ml/site) or 3 separate vaccinations of placebo (Arm B: 0.8 ml total, administered over two skin sites of 80 cm\^2 each, 0.4 ml/site). Vaccinations were given over two skin sites on the left and right upper back. Participants received vaccinations at weeks 1, 7, and 13.
* In Cohort 2, participants received three separate high-dose vaccinations of LC002 (Arm C: 0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site) or three separate vaccinations of placebo (Arm D: 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site). Vaccinations were given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants received vaccinations at weeks 1, 7, and 13.
* In Cohort 3, participants received six separate high-dose vaccinations of LC002 (Arm E: 0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site) or six vaccinations of placebo (Arm F: 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site). Vaccinations were given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants received vaccinations at study entry and weeks 1, 6, 7, 12, and 13.
The decision to open the next cohort was made when all participants in the current cohort have remained on study for \>=14 days after the second vaccination or prematurely discontinued from study or had a primary safety endpoint (see primary outcome measure definition). Dose escalation required no primary safety endpoint and on-study follow-up for \>=6 participants in the previous cohort(s).
Prior to receiving the vaccine, the chosen vaccine administration site on the back or thigh was disinfected and exfoliated. A skin patch was applied to the site, and the vaccine solution was placed on the skin underneath the patch with a needleless syringe. Participants were allowed to remove the skin patch 3 hours post vaccination. For the first and second vaccinations, participants were required to remain at the clinic for 3 hours post-vaccination so study staff can assess for side effects. If no side effects occurred after the first two vaccinations, participants were required to stay at the clinic for only 30 minutes after receiving later vaccinations.
At the start of the study, participants were asked to keep a diary and record daily any side effects or skin irritation they may have experienced following vaccination. Participants were required to bring their diaries with them to their next clinic visit. Two days after vaccination, participants were followed-up by phone and were asked about any side effects they may have experienced. Participants who experienced side effects were asked to return to the clinic for examination. There were 13 study visits; they occurred at study entry and Weeks 1, 3, 6, 7, 9, 12, 13, 15, 17, 24, 37, and 61. Study visits included medication history, a physical exam, and collection of diaries. Blood and urine collection occurred at selected visits. HAART was not be provided by the study.
There were three cohorts in this study which were enrolled sequentially. Participants in a given cohort were randomly assigned to receive either LC002 (6 participants) or placebo (2 participants).
* In Cohort 1, participants received three separate low-dose vaccinations of LC002 (Arm A: 0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites of 80 cm\^2 each, 0.4 ml/site) or 3 separate vaccinations of placebo (Arm B: 0.8 ml total, administered over two skin sites of 80 cm\^2 each, 0.4 ml/site). Vaccinations were given over two skin sites on the left and right upper back. Participants received vaccinations at weeks 1, 7, and 13.
* In Cohort 2, participants received three separate high-dose vaccinations of LC002 (Arm C: 0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site) or three separate vaccinations of placebo (Arm D: 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site). Vaccinations were given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants received vaccinations at weeks 1, 7, and 13.
* In Cohort 3, participants received six separate high-dose vaccinations of LC002 (Arm E: 0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site) or six vaccinations of placebo (Arm F: 3.2 ml total, administered over four skin sites of 80 cm\^2 each, 0.8 ml/site). Vaccinations were given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants received vaccinations at study entry and weeks 1, 6, 7, 12, and 13.
The decision to open the next cohort was made when all participants in the current cohort have remained on study for \>=14 days after the second vaccination or prematurely discontinued from study or had a primary safety endpoint (see primary outcome measure definition). Dose escalation required no primary safety endpoint and on-study follow-up for \>=6 participants in the previous cohort(s).
Prior to receiving the vaccine, the chosen vaccine administration site on the back or thigh was disinfected and exfoliated. A skin patch was applied to the site, and the vaccine solution was placed on the skin underneath the patch with a needleless syringe. Participants were allowed to remove the skin patch 3 hours post vaccination. For the first and second vaccinations, participants were required to remain at the clinic for 3 hours post-vaccination so study staff can assess for side effects. If no side effects occurred after the first two vaccinations, participants were required to stay at the clinic for only 30 minutes after receiving later vaccinations.
At the start of the study, participants were asked to keep a diary and record daily any side effects or skin irritation they may have experienced following vaccination. Participants were required to bring their diaries with them to their next clinic visit. Two days after vaccination, participants were followed-up by phone and were asked about any side effects they may have experienced. Participants who experienced side effects were asked to return to the clinic for examination. There were 13 study visits; they occurred at study entry and Weeks 1, 3, 6, 7, 9, 12, 13, 15, 17, 24, 37, and 61. Study visits included medication history, a physical exam, and collection of diaries. Blood and urine collection occurred at selected visits. HAART was not be provided by the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: