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

PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). Subjects will be randomized to receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.

Start Date01 Apr 2009

Sponsor / Collaborator

Genetic Immunity, Inc.

[+1]

NCT00711230

/ CompletedPhase 2

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

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.
GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

Start Date01 Apr 2008

Sponsor / Collaborator

Genetic Immunity, Inc.

[+1]

NCT00270205

/ CompletedPhase 1/2IIT

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)

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.

Start Date01 Jan 2006

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

100 Clinical Results associated with DermaVir

100 Translational Medicine associated with DermaVir

100 Patents (Medical) associated with DermaVir

Literatures (Medical) associated with DermaVir

01 Dec 2013·JAIDS Journal of Acquired Immune Deficiency SyndromesQ3 · MEDICINE

Safety, Tolerability, and Immunogenicity of Repeated Doses of DermaVir, a Candidate Therapeutic HIV Vaccine, in HIV-Infected Patients Receiving Combination Antiretroviral Therapy

Q3 · MEDICINE

Article

Author: Mailliard, Robbie B. ; Jacobson, Jeffrey M. ; Lori, Franco ; Spritzler, John ; Lisziewicz, Julianna ; Rodriguez, Benigno ; Pollard, Richard B. ; Tenorio, Allan R. ; Martinez, Ana I. ; Rinaldo, Charles R. ; Yesmin, Suria ; Asmuth, David M. ; Matining, Roy M. ; Li, Xiao-Dong

BACKGROUNDHIV-specific cellular immune responses are associated with control of viremia and delayed disease progression. An effective therapeutic vaccine could mimic these effects and reduce the need for continued antiretroviral therapy. DermaVir, a topically administered plasmid DNA-nanomedicine expressing HIV (CladeB) virus-like particles consisting of 15 antigens, induces predominantly central memory T-cell responses.METHODSTreated HIV-infected adults (HIV RNA <50 and CD4 >350) were randomized to placebo or escalating DermaVir doses (0.1 or 0.4 mg of plasmid DNA at weeks 1, 7, and 13 in the low- and intermediate-dose groups and 0.8 mg at weeks 0, 1, 6, 7, 12, and 13 in the high-dose group), n = 5-6 evaluable subjects per group. Immunogenicity was assessed by a 12-day cultured interferon-γ enzyme-linked immunosorbent spot assay at baseline and at weeks 9, 17, and 37 using 1 Tat/Rev and 3 overlapping Gag peptide pools (p17, p24, and p15).RESULTSGroups were comparable at baseline. The study intervention was well tolerated, without dose-limiting toxicities. Most responses were highest at week 17 (4 weeks after last vaccination) when Gag p24 responses were significantly greater among intermediate-dose group compared with control subjects [median (IQR): 67,600 (5633-74,368) versus 1194 (9-1667)] net spot-forming units per million cells, P = 0.032. In the intermediate-dose group, there was also a marginal Gag p15 response increase from baseline to week 17 [2859 (1867-56,933), P = 0.06], and this change was significantly greater than in the placebo group [0 (-713 to 297), P = 0.016].CONCLUSIONSDermaVir administration was associated with a trend toward greater HIV-specific, predominantly central memory T-cell responses. The intermediate DermaVir dose tended to show the greatest immunogenicity, consistent with previous studies in different HIV-infected patient populations.

01 Jan 2013·Nanomedicine: Nanotechnology, Biology and MedicineQ2 · MEDICINE

Nanomedicine applications towards the cure of HIV

Q2 · MEDICINE

Review

Author: Enikő R. Tőke ; Julianna Lisziewicz

Combination antiretroviral therapy (cART) successfully suppresses HIV replication. However, daily and lifelong treatment is necessary to manage patient illness because cART neither eradicates infected cells from reservoirs nor reconstitutes HIV-specific immunity that could kill infected cells. Toward the cure of HIV, different nanomedicine classes have been developed with the following disease-modifying properties: to eradicate the virus by activation of latently infected CD4+ T-cells and reservoirs flushing; to kill the infected cells in the reservoirs by boosting of HIV-specific T cells; and to prevent infection by the use of microbicides with improved epithelial penetration and drug half-life. Preclinical and clinical trials consistently demonstrated that DermaVir, the most advanced nanomedicine, induces long-lasting memory T-cell responses and reduces viral load in comparison with placebo. DermaVir and the nanomedicine pipelines have the potential to improve the health of HIV-infected people at lower costs, to decrease antiretroviral drug exposure, and to contribute to the cure of HIV/AIDS.FROM THE CLINICAL EDITORDespite the leaps and bounds in the development of antiretroviral therapy, HIV remains a significant public health challenge. In this review, applications of nanomedicine- based technologies are discussed in the context of HIV treatment, including virus elimination by activation of latently infected CD4+ T-cells; infected cell elimination in the reservoirs by boosting HIV-specific T cells, and by preventing infection by the use of microbicides with improved epithelial penetration and drug half-life.

01 May 2012·Nanomedicine: Nanotechnology, Biology and MedicineQ2 · MEDICINE

Structure and biological activity of pathogen-like synthetic nanomedicines

Q2 · MEDICINE

Article

Author: Julianna Lisziewicz ; Eszter Somogyi ; Jack F. Douglas ; János Szebeni ; Orsolya Lőrincz ; Enikő R. Tőke ; Preethi L. Chandran ; Ferenc Horkay

Here we characterize the structure, stability and intracellular mode of action of DermaVir nanomedicine that is under clinical development for the treatment of HIV/AIDS. This nanomedicine comprises pathogen-like pDNA/PEIm nanoparticles (NPs) having the structure and function resembling spherical viruses that naturally evolved to deliver nucleic acids to the cells. Atomic force microscopy demonstrated spherical 100 - 200 nm NPs with a smooth polymer surface protecting the pDNA in the core. Optical absorption determined both the NP structural stability and biological activity relevant to their ability to escape from the endosome and release the pDNA at the nucleus. Salt, pH and temperature influence nanomedicine shelf-life and intracellular stability. This approach facilitates the development of diverse polyplex nanomedicines where the delivered pDNA-expressed antigens induce immune responses to kill infected cells.FROM THE CLINICAL EDITORThe authors investigated DermaVir nanomedicine comprised of pathogen-like pDNA/PEIm nanoparticles with structure and function resembling spherical viruses. DermaVir delivery of pDNA expresses antigens that induce immune responses to kill HIV infected cells.

News (Medical) associated with DermaVir

03 Dec 2024

·www.businesswire.com

Genetic Immunity (GI) Leverages VectorBuilder Partnership to Power Phase 3 HIV Vaccine Trials

CHICAGO--( BUSINESS WIRE )-- Genetic Immunity , a leader in plasmid DNA-based immunotherapies, and VectorBuilder , a global specialist in gene delivery solutions, announced a strategic partnership to advance Genetic Immunity's innovative HIV vaccine into a late-stage clinical trial. Renowned for its focus on developing cutting-edge DNA-based vaccines, Genetic Immunity has built an industry-leading team to deliver its lead candidate, a plasmid DNA HIV vaccine, into a Phase 3 trial. The therapy has demonstrated promising clinical readouts in previous trials, paving the way for the upcoming Phase 3 pivotal trial. Under this collaboration, VectorBuilder will provide a Quality by Design (QbD) approach to Process Development, Process Characterization, and GMP Manufacturing services for Genetic Immunity. This includes end-to-end production of the plasmid DNA required for the clinical trial and future commercial manufacturing. Dr. Bruce Lahn, Chief Scientist at VectorBuilder, said: “We are thrilled to support Genetic Immunity’s innovative approach to HIV treatment. After working closely with them over the last few years, we have created a wonderful partnership that has allowed us to holistically understand their modality to ensure we have a high probability of success. Our comprehensive gene delivery solutions are designed to meet the stringent requirements of GIs clinical and CMC development, and we are committed to ensuring the success of this important vaccine trial and beyond to commercial rollout.” Dr. Philip C. Onyebujoh [Chief Medical Director of Genetic Immunity]: “Genetic Immunity’s partnership with VectorBuilder represents an important fusion of technological innovation and therapeutic advancement towards providing interventions that are expected to improve treatment outcomes for the control of critical infectious diseases. This partnership offers a unique coupling that synergistically creates, drives, and advances therapeutic sciences to harness the power of immunomodulation to address a host of disease conditions, including cancers and infectious diseases of poverty. We welcome our partnership with VectorBuilder and look forward to further growth together.” For more information about VectorBuilder’s services, visit VectorBuilder . For details on Genetic Immunity’s vaccine development, visit Genetic Immunity . About VectorBuilder Inc. VectorBuilder is a global leader in gene delivery technologies. As a trusted partner in thousands of labs and biotech/pharma companies around the world, VectorBuilder is a one-stop shop for the design, development and optimization of gene delivery solutions from basic research to clinical applications. Its award-winning Vector Design Studio is a transformative innovation that allows researchers to easily design and order custom vectors online, freeing them from the tedious work of cloning and packaging vectors in the lab. The global company boasts high-throughput vector production capacity, vast vector and component inventories, one-on-one CRO solutions that include advanced AAV capsid engineering capabilities and state-of-the-art GMP facilities. With leading R&D and CDMO manufacturing capacity, the VectorBuilder team strives to provide the most effective gene delivery solutions and develop new tools for life sciences research and genetic medicine. About Genetic Immunity GI.HU Ltd. is a Hungarian clinical-stage biotechnology company focusing on discovering and developing plasmid-based DNA (pDNA) therapeutic vaccines for cancer and infectious diseases. For example, therapeutic vaccines for HIV control are designed to improve the immune response to HIV antigens in HIV-infected people, aiming at attaining functional cure. Genetic Immunity’s lead product candidate DermaVir ® is a therapeutic vaccine for the adjunctive treatment of HIV. The preclinical and early phase clinical trials have demonstrated an effective boosting of HIV-specific memory T-cell responses. DermaVir ® has an excellent safety profile similar to traditional vaccines used in healthy adults. The intended use of DermaVir ® is to complement antiretroviral therapy as an add-on treatment option to maintain undetectable HIV-RNA levels with associated improvement in the quality of life of people living with HIV.

VaccinePhase 3Immunotherapy

100 Deals associated with DermaVir

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	-	Virostatics Srl	-
Acquired Immunodeficiency Syndrome	Phase 1	Germany	Genetic Immunity, Inc.	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00712530 (GIHU004, CTgov)	Phase 1	HIV Infections	9	DermaVir (Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization)	gylzyoetdx(dyympeiihs) = cccorqolab zyplnqmbpo (vhtlblwvxu, ltagcdpdzz - nwujimzpmz) View more	-	26 Mar 2013
				DermaVir (Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization)	gylzyoetdx(dyympeiihs) = igzbrszqil zyplnqmbpo (vhtlblwvxu, pflzgvbphm - cdpuwdaspo) View more
NCT00270205 (CTgov)	Phase 1/2	HIV Infections	28	LC002 high-dose vaccination (C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13)	zkjlfmrqvt(tfwjimymod) = ielljidgjf bfpmtxlmaq (ttwtnskfpi, bstlzpmbvf - tuficfvvqt) View more	-	13 Oct 2011
				LC002 high-dose vaccination (E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13)	zkjlfmrqvt(tfwjimymod) = iihglkuqkx bfpmtxlmaq (ttwtnskfpi, okazpgyyku - hydxuhjcdr) View more
ACTG protocol A5176 (IAS2011)	Not Applicable	HIV Infections	-	DermaVir	sduiqmuler(uexmwrqkvr) = yeteshyose oqbxdxsavx (ajxysmrlyr ) View more	-	01 Jan 2011
				Placebo	sduiqmuler(uexmwrqkvr) = awpxeiohwq oqbxdxsavx (ajxysmrlyr ) View more
NCT00711230 (GIEU006, IAS2010)	Phase 2	HIV Infections	36	DermaVir Patch 0.4 mg	zmacmxptsk(njrhthqiyk) = did not change wrclbuktyt (dcdisvmusj ) View more	-	01 Jan 2010
				Placebo

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