Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients

NCT00711230 | Completed Phase 2 DMC

• 2 other identifiers: DermaVir Phase II2007-001955-20
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV Infection

Keywords

HIV; Vaccine; Immune Therapy; DermaVir

Outcome Measures

Primary Outcomes (1)

• Percent of participants with primary safety endpoint

  Primary safety endpoint: occurrence of at least two \> Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment (as judged by the GIEU006 team, including site clinicians on the team, blinded to treatment arm) any time from the first day of study treatment until 42 days after the last study vaccine administration.

  24 weeks

Secondary Outcomes (3)

• HIV-1 RNA

  24 weeks

• CD4+ and CD8+ T-cell counts

  24 weeks

• HIV-specific memory T cell responses

  24 weeks

Study Arms (6)

1: Low dose DermaVir

EXPERIMENTAL

* Dosage: 0.2 mg DNA * Dosage form: 1.6 mL DNA/PEIm nanomedicine * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)

Biological: DermaVir

2: Low dose Placebo

EXPERIMENTAL

* Dosage form: 1.6 mL Placebo * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)

Biological: Placebo

3: Medium dose DermaVir

EXPERIMENTAL

* Dosage: 0.4 mg DNA * Dosage form: 3.2 mL DNA/PEIm nanomedicine * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)

Biological: DermaVir

4: Medium dose Placebo

EXPERIMENTAL

* Dosage form: 1.6 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)

Biological: Placebo

5: High dose DermaVir

EXPERIMENTAL

* Dosage: 0.8 mg DNA * Dosage form: 6.4 mL DNA/PEIm nanomedicine * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)

Biological: DermaVir

6: High dose Placebo

EXPERIMENTAL

* Dosage form: 6.4 mL Placebo * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)

Biological: Placebo

Interventions

DermaVir BIOLOGICAL

Also known as: LC002

1: Low dose DermaVir; 3: Medium dose DermaVir; 5: High dose DermaVir

Placebo BIOLOGICAL

glucose/dextrose

2: Low dose Placebo; 4: Medium dose Placebo; 6: High dose Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV antibody positive
• Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL
• Antiretroviral therapy naïve
• Documented CD4+ T-cell count at screening ≥400 cells/mm3

You may not qualify if:

• No skin disease
• No tattoos, or changes in pigmentation at the selected skin immunization sites
• No acute or chronic illness (e.g Hepatitis C)
• No chronic autoimmune diseases
• No treatment with any immune modulating agents

Sponsors & Collaborators

• Genetic Immunity: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (3)

ifi-Medizin GmbH at the Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

ICH Grindel

Hamburg, 20146, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, 20249, Germany

Location

Related Publications (10)

• Lisziewicz J, Bakare N, Calarota SA, Banhegyi D, Szlavik J, Ujhelyi E, Toke ER, Molnar L, Lisziewicz Z, Autran B, Lori F. Single DermaVir immunization: dose-dependent expansion of precursor/memory T cells against all HIV antigens in HIV-1 infected individuals. PLoS One. 2012;7(5):e35416. doi: 10.1371/journal.pone.0035416. Epub 2012 May 9.

  PMID: 22590502 BACKGROUND

• Lisziewicz J, Toke ER. Nanomedicine applications towards the cure of HIV. Nanomedicine. 2013 Jan;9(1):28-38. doi: 10.1016/j.nano.2012.05.012. Epub 2012 May 30.

  PMID: 22659241 BACKGROUND

• Lorincz O, Toke ER, Somogyi E, Horkay F, Chandran PL, Douglas JF, Szebeni J, Lisziewicz J. Structure and biological activity of pathogen-like synthetic nanomedicines. Nanomedicine. 2012 May;8(4):497-506. doi: 10.1016/j.nano.2011.07.013. Epub 2011 Aug 10.

  PMID: 21839051 BACKGROUND

• Toke ER, Lorincz O, Somogyi E, Lisziewicz J. Rational development of a stable liquid formulation for nanomedicine products. Int J Pharm. 2010 Jun 15;392(1-2):261-7. doi: 10.1016/j.ijpharm.2010.03.048. Epub 2010 Mar 25.

  PMID: 20347027 BACKGROUND

• Lori F. DermaVir: a plasmid DNA-based nanomedicine therapeutic vaccine for the treatment of HIV/AIDS. Expert Rev Vaccines. 2011 Oct;10(10):1371-84. doi: 10.1586/erv.11.118.

  PMID: 21988301 BACKGROUND

• Somogyi E, Xu J, Gudics A, Toth J, Kovacs AL, Lori F, Lisziewicz J. A plasmid DNA immunogen expressing fifteen protein antigens and complex virus-like particles (VLP+) mimicking naturally occurring HIV. Vaccine. 2011 Jan 17;29(4):744-53. doi: 10.1016/j.vaccine.2010.11.019. Epub 2010 Nov 23.

  PMID: 21109034 BACKGROUND

• Calarota SA, Weiner DB, Lori F, Lisziewicz J. Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine. Vaccine. 2007 Apr 20;25(16):3070-4. doi: 10.1016/j.vaccine.2007.01.024. Epub 2007 Jan 22.

  PMID: 17292518 BACKGROUND

• Lisziewicz J, Trocio J, Whitman L, Varga G, Xu J, Bakare N, Erbacher P, Fox C, Woodward R, Markham P, Arya S, Behr JP, Lori F. DermaVir: a novel topical vaccine for HIV/AIDS. J Invest Dermatol. 2005 Jan;124(1):160-9. doi: 10.1111/j.0022-202X.2004.23535.x.

  PMID: 15654970 BACKGROUND

• Lori F, Trocio J, Bakare N, Kelly LM, Lisziewicz J. DermaVir, a novel HIV immunisation technology. Vaccine. 2005 Mar 18;23(17-18):2030-4. doi: 10.1016/j.vaccine.2005.01.004.

  PMID: 15755566 BACKGROUND

• Lisziewicz J, Trocio J, Xu J, Whitman L, Ryder A, Bakare N, Lewis MG, Wagner W, Pistorio A, Arya S, Lori F. Control of viral rebound through therapeutic immunization with DermaVir. AIDS. 2005 Jan 3;19(1):35-43. doi: 10.1097/00002030-200501030-00004.

  PMID: 15627031 BACKGROUND

Related Links

• Genetic Immunity's homepage
• DermaVir for initial treatment of HIV-infected subjects demonstrates preliminary safety, immunogenicity and HIV-RNA reduction versus placebo immunization

MeSH Terms

Conditions

HIV Infections

Interventions

DermaVir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jan Van Lunzen, PhD, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2008
• First Posted: July 8, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2015
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

DE (3)