dermavir: emerging a novel topical vaccine for hiv/aids

Mahesh ShahiB.Pharm, 4th Semester

Crimson College of Technology

DermaVir: Emerging A Novel Topical Vaccine For HIV/AIDS

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Contents

Quick review about HIV/AIDS

Structure of HIV virus

Life cycle of HIV virus

Treatment

Introduction

Need; No Cure & No Vaccine for HIV

Prophylactic Vs Therapeutic vaccine

Facts

Why Nanomedicine

for vaccination ?

DermaPrep and way

to administration

Clinical trials & its

result

Big challenge

Conclusion

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Introduction History

Transmission Symptoms

Treatment

HIV AIDS: Quick Review

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Structure of HIV Virus

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Life Cycle of HIV Virus

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Introduction

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Need: No Cure & No Vaccine for HIV

HIV treatment with Drugs: HIV treatment with DermaVir: Minimum 3 drugs - Drug sparing & immune boosting Daily doses - During regular visits (3 months) Systemic toxicities - Transient local toxicities (skin) No full life expectancy (~ 11yr) - Remission (functional cure)

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Present & Future VaccineThere is no HIV Vaccine

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PROPHYLACTIC VACCINEVS

THERAPEUTIC VACCINE

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Facts

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Why do we need nanomedicine for Therapeutic vaccination ?

Scientific reason To target in vivo the antigen to Dendritic cells

Medical reason To provide safe, effective and curative treatment for HIV

Business reason To treat >33 million people

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NEW TechnologyDendritic Cell-based Therapeutic Vaccines

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“Pathogen-like Nanoparticle” The pDNA and mannosylated polymer self-assemble to form

nanoparticle that1. Structure &2. MoA for targeted pDNA delivery to cells resembles a pathogen

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DermaVir Therapeutic Vaccine Formulation“Pathogen-like Nanoparticles”

The pDNA nanomedicine is filled into a neddle-free applicator ready for delivery with the DermaPrep device

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Challenge:HIV-1 diversity & genetic diversityObjective: Optimal treatment efficacy in every patientsSolution: DermaVir family with related pDNA covering the

immunological clusters

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Personalized TreatmentOptimal Vaccine for every Patients

DermaPrep & way to administer ???

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Logistics of DermaVir Therapeutic Vaccination

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DermaVir TherapeuticVaccine Administration“DermaPrep”

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Mechanism of Action

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DermaVir is safe & well toleratedConsistent Preclinical & Clinical Results

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DermaVir Boosted Immune System to Fight HIVPhase I/II Clinical Trial Results

GIHU004 study(PI:D, Banhegyi MD,Hungary)- HIV (+VE) subjects on HAART,HIV-RNA <50 copies/ml, CD4> 350/mm3

- 3 subjects/dose; 0.1, 0.4, 0.8mg doses; single DermaVir immunization

Safety Analysis- Single DermaVir treatment was safe and well-tolerated at all doses

Immunogenicity analysis- Antigen-specific memory/precursor T cells are boosted in all subjects

Note: Highest immunogenicity – 0.4 mg DermaVir (4 DermaPrep)

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Contd…

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Another BIG Challenge ???

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ART???

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Reasons for Possible !!!

Effectiveness based upon boosted natural immunity

Delayed disease progression

No interference with current or future drug-treatment options

No systemic toxicities

Infrequent administration of a patch (only for three hours)

during regular office visits

No fear of the side effects and acquiring resistance of anti-HIV

drugs

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DermaVir Immune Boosting to Fight HIVAntiretroviral sparing Therapeutic Vaccine

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DermaVir Immune IntenficationTestable Hypothesis: DermaVir Superiority to HARRT

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URL : journals.plos.org/plosone/article?id=10.1371/journal.pone.0035416

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Contd…

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Conclusion

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Prevention Is Better

Than Cure !!! –no way…

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References Tripathi KD (2008) Essential Medical Pharmacology (6th Ed.), Jaypee Brothers

Publishers Private Limited, New Delhi, India, pp (770-776).

Katzung BG (2007) Basic and Clinical Pharmcology (10th Ed.), McGraw-Hill Medical, New

York, USA, pp (798-811).

URL : http://www.geneticimmunity.com/dermavir.html (Assessed on: November 9, 2016).

URL : https://www.ncbi.nlm.nih.gov/pubmed/24169 (Assessed on: November 15, 2016).

URL : journals.plos.org/plosone/article?id=10.1371/journal.pone.0035416 (Assessed on:

November 16, 2016).

URL : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157563/ (Assessed on: November 20,

2016).

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Presented by;MAHESH SHAHIPharmaceutical Seminar - III

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