Safety and Tolerability of and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving Anti-HIV Treatment

2014-08-27 03:46:58 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


HIV Infections


LC002 standard vaccination, LC002 high-dose vaccination, LC002 placebo vaccination


University of California, Davis Medical Center
United States




National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:46:58-0400

Clinical Trials [2351 Associated Clinical Trials listed on BioPortfolio]

DermaVir Patch (LC002) in HIV-1 Infected Patients Currently on HAART

GIHU004, a phase I sequential dose escalation cohort study is designed to evaluate the safety and immunogenicity of three dosing regimens of LC002 for the treatment of individuals with chr...

DermaVir Patch (LC002) in HIV-1 Infected Treatment-naïve Patients

GIEU-006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded study to assess the safety, tolerability, immunogenicity, and antiretroviral activity of a candidate top...

Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a ...

Vaccination for Children of H&O and Their Parents

The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents.

Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very of...

PubMed Articles [20772 Associated PubMed Articles listed on BioPortfolio]

Increases in Human Papillomavirus Vaccination Among Adolescent and Young Adult Males in the United States, 2011-2016.

In the U.S., HPV vaccination has been recommended for females since 2006 and males since 2011. We assessed temporal trends in HPV vaccination (≥1 dose) among 9-26-year-olds in the 2011-2016 NHANES. ...

Assessment of the timely administration of the hepatitis B and BCG birth dose and the primary infant vaccination schedule in 2015-2016 in the Mekong Delta, Viet Nam.

Vietnam is implementing hepatitis B (HBV) birth dose (BD) vaccination since 2003 but coverage remains low, especially in the Mekong River Delta. This study aimed to determine the coverage of the HBV B...

Hepatitis B vaccination among 1997-2011 birth cohorts in rural China: the potential for further catch-up vaccination and factors associated with infant coverage rates.

Hepatitis B vaccination rates in China have recently increased. This study aimed to investigate infant vaccination coverage for birth cohorts from 1997 to 2011 in rural regions and to assess catch-up ...

Efficacy and effectiveness of high-dose versus standard-dose influenza vaccination for older adults: A systematic review and meta-analysis.

Influenza is responsible for a significant disease burden annually, especially in older adults. This study reviews the relative vaccine efficacy or effectiveness (rVE) of high-dose inactivated trivale...

Effect of sex on vaccination outcomes: important but frequently overlooked.

It is well established that vaccination does not affect males and females equally. For example, females generally mount greater antibody responses to vaccination than males, but also suffer more adver...

Medical and Biotech [MESH] Definitions

Rate of VACCINATION as defined by GEOGRAPHY and or DEMOGRAPHY.

Group activities directed against VACCINATION.

Refusal to receive VACCINATION.

The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.

Administration of a vaccine to large populations in order to elicit IMMUNITY.

More From BioPortfolio on "Safety and Tolerability of and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving Anti-HIV Treatment"

Quick Search


Relevant Topics

A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...

Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...

Searches Linking to this Trial