dermavir: emerging a novel topical vaccine for hiv/aids
TRANSCRIPT
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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