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Merck HPV Vaccine

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Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine. VLPs manufactured in S. cerevisiae ... HPV L1 VLP vaccines reduce risk for. acquisition of HPV infection ... – PowerPoint PPT presentation

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Title: Merck HPV Vaccine


1
Merck HPV Vaccine
  • Kathrin Jansen
  • Eliav Barr
  • Alan Shaw

2
HPV Infection Causes Epithelial Neoplasia
Shedding of virus-laden cells
Cervical Surface
Viral assembly
Viral DNA in nucleus of infected basal cells
Normal Epithelium
Cervical Intraepithelial Neoplasia
3
Mercks Investigational L1 VLP Vaccines
  • Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP
    vaccine
  • VLPs manufactured in S. cerevisiae
  • Technology similar to that used for Mercks
    RECOMBIVAX HB Hepatitis B vaccine
  • Yeast-derived vaccines administered to millions
    of children and adults
  • Mercks Aluminum Adjuvant 225 mg per dose
  • 0.5 mL injection volume
  • 0, 2, 6 (month) dosing regimen

4
Clinical Program Conducted in 3 Phases
  • Phase I IIa
  • Preliminary assessment of immunogenicity and
    tolerability of a broad range of doses of
    monovalent HPV L1 VLP vaccines
  • Preliminary efficacy assessment of a monovalent
    HPV vaccine in women (proof of principle study)
  • Phase IIb
  • Immunogenicity and tolerability of a range of
    quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP
    vaccine dose formulations
  • Logistics for large-scale international clinical
    trials
  • Phase III
  • Demonstrate that HPV L1 VLP vaccines reduce risk
    for
  • acquisition of HPV infection and early endpoints
  • development of a broad spectrum of HPV-related
    diseases

5
Postdose 3 (Month 7) Anti-HPV RIA GMTs(mMU/mL)
with 95 CIs
1000
Geometric Mean Titer (mMU/mL)
Placebo
20/40/40/20 mg
100
40/40/40/40 mg
80/80/40/80 mg
10
GMTs assoc. with Nat. Inf. 95 CI
HPV 11
HPV 16
HPV 18
HPV 6
6
Protocol 005 Proof of Principle Efficacy Study
  • Randomized, double-blind (in-house blinding),
    placebo-controlled study of HPV 16 vaccine pilot
    manufacturing material
  • In 2392 young women with ?5 lifetime male sex
    partners
  • Primary endpoint
  • Persistent HPV 16 infection (PCR) and/or
  • HPV 16-related CIN

7
Proof of Principle Efficacy Study Primary
Efficacy Result
  • Median Subject-Years at Risk (SYR) 1.41 years
    (17 months)
  • Median duration of incident HPV infection 12.4
    months
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