Drug Database: LC002

What is LC002?

LC002 is an investigational vaccine that is being studied as a possible strategy to treat people living with HIV. LC002 belongs to a group of HIV vaccines called therapeutic HIV vaccines.²

To learn how investigational vaccines and drugs are tested during clinical trials, read the HIVinfo What is an Investigational HIV Drug? and HIV and AIDS Clinical Trials fact sheets.

How do therapeutic HIV vaccines work?

A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person living with HIV.⁴ Therapeutic vaccines may be able to reduce the amount of HIV in the body and help keep HIV at undetectable levels without the need for the regular use of antiretroviral therapy (ART).⁵ To learn more, read the HIVinfo What is a Therapeutic HIV Vaccine? fact sheet.

There are several types of therapeutic vaccines currently being studied to treat HIV. LC002 is a DNA vaccine developed using HIV’s genetic information. The aim of the vaccine is to produce an immune response against HIV in the body.⁶

Select clinical trials of LC002

Study Names: ACTG 5176; A5176; NCT00270205
Phase: 1/2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of LC002 and its ability to produce an immune response in people with chronic HIV infection.^7,8
Selected Study Results: Results published in J Acquir Immune Defic Syndr showed that LC002 was well-tolerated without dose-limiting toxicities. Memory T-cell responses improved following vaccination with LC002.⁷
Additional Published Material:

• IAS, 2011: DermaVir as a therapeutic vaccination strategy for HIV infection: results from ACTG protocol A5176

Study Names: GIEU006; NCT00711230
Phase: 2
Status: This study has been completed.
Location: Germany
Purpose: The purpose of this study was to evaluate the safety of LC002 and its ability to produce an immune response in people with HIV who have never taken HIV medicines. This study also looked at LC002’s ability to reduce viral load levels.⁹
Selected Study Results: Results presented at the 2010 AIDS conference showed that LC002 was safe, well-tolerated, and effective in participants who never received antiretroviral therapy before.¹⁰

Study Name: GIRU001
Phase: 3
Status: This study is ongoing.
Location: Russia
Purpose: The purpose of this study is to evaluate the ability of LC002 to produce an immune response and reduce viral load levels in people with HIV who have never taken HIV medicines.³

For more details on the studies listed above, see the Health Professional version of this drug summary.

Additional clinical trials evaluating LC002 have also been completed, including a Phase 2 trial (NCT00918840) that looked at LC002’s ability to produce an immune response in the body and the impact of treatment with LC002 on viral load levels during an analytical treatment interruption of ART.¹¹

What side effects might LC002 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of LC002 listed above.

In this study, the most common side effects reported by participants were general body complaints, such as aches, pain, discomfort, fatigue, or fever. Some participants had skin reactions, such as itchiness and rash, as well as abnormal blood tests. All LC002-related side effects that occurred during the trial were mild or moderate in severity. None of the participants stopped or changed their treatment because of a side effect.⁷

All side effects reported by participants in this study were considered mild or moderate. None of the participants stopped treatment because of side effects. Only one side effect (limb pain under stress) was possibly related to LC002, but this side effect went away before the end of the study.¹⁰

Because LC002 is still being studied, information on possible side effects of the vaccine is not complete. As testing of LC002 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying LC002?

More information about LC002-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

References

1. National Center for Biotechnology Information. PubChem Substance Record for SID 439785090, LC002, Source: ChemIDplus. https://pubchem.ncbi.nlm.nih.gov/substance/439785090. Accessed March 6, 2023
2. Treatment Action Group website. Research toward a cure trials. https://www.treatmentactiongroup.org/cure/trials/. Accessed August 16, 2022
3. Genetic Immunity website. DermaVir. https://www.geneticimmunity.com/dermavir.html. Accessed August 16, 2022
4. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed August 16, 2022
5. Graziani GM, Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015;18(1):20497.
6. Genetic Immunity website. Our immune-therapy technology platform. https://www.geneticimmunity.com/products.html. Accessed August 16, 2022
7. Rodriguez B, Asmuth DM, Matining RM, et al. Safety, tolerability and immunogenicity of repeated doses of DermaVir, a candidate therapeutic HIV vaccine, in HIV infected patients receiving combination antiretroviral therapy. Results of the ACTG 5176 trial. J Acquir Immune Defic Syndr. 2013;64(4):351-359. doi:10.1097/QAI.0b013e3182a99590
8. National Institute of Allergy and Infectious Diseases (NIAID). 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). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 21, 2005. NLM Identifier: NCT00270205. https://www.clinicaltrials.gov/ct2/show/NCT00270205. Accessed August 16, 2022
9. Genetic Immunity. A Phase II randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, immunogenicity, and antiretroviral activity of DermaVir patch (LC002) in treatment-naïve HIV-1-infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 4, 2008. NLM Identifier: NCT00711230. https://www.clinicaltrials.gov/ct2/show/NCT00711230. Accessed August 16, 2022
10. van Lunzen J, Pollard R, Stellbrink H-J, et al. DermaVir for initial treatment of HIV-infected subjects demonstrates preliminary safety, immunogenicity and HIV-RNA reduction versus placebo immunization. Poster presented at: International AIDS Conference; July 18-23, 2010; Vienna, Austria. https://www.researchgate.net/publication/264848719_DermaVir_for_initial_treatment_of_HIV-infected_subjects_demonstrates_preliminary_safety_immunogenicity_and_HIV-RNA_reduction_versus_placebo_immunization_A-240-0111-_12561. Accessed August 16, 2022
11. Genetic Immunity. Antiretroviral-sparing concept: an exploratory Phase II, randomized, single blind placebo-controlled study to investigate the effect of therapeutic immunization on the quantity of HIV-specific T cell precursors during highly active antiretroviral therapy followed by analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 8, 2009. NLM Identifier: NCT00918840. https://www.clinicaltrials.gov/ct2/show/NCT00918840. Accessed August 16, 2022