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International AIDS Vaccine Initiative

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Clinical trials in Europe. IAVI as facilitator of community involvement ... Pre-clinical. Biological idea/concept. Laboratory development. Construction of product GLP ... – PowerPoint PPT presentation

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Title: International AIDS Vaccine Initiative


1
International AIDS Vaccine Initiative
  • UK CAB
  • May 21, 2004
  • Maite Suárez, European Country Programmes Officer

2
IAVI
  • International, scientific, non for profit
    organisation
  • HQ New York
  • European offices in Amsterdam, working space in
    Brussels
  • Offices in Nairobi and New Delhi
  • IAVIs mission is
  • To accelerate the development of a safe and
    effective preventive AIDS vaccine and to ensure
    that once is available it will be readily
    accessible, especially to those most in need

3
IAVI Strategies
  • Accelerate RD
  • Promising candidates ? clinical trials in the
    South
  • Mobilise public support to AIDS vaccines
  • Awareness, information, political lobbying
  • Facilitate the involvement of the private sector
  • Preserving social objectives (proprietary
    arrangements)
  • Prepare global access to AIDS vaccines
  • Key part of the comprehensive response against
    HIV/AIDS
  • Global effort? Alliances

4
IAVI Key Driving Ideas
  • Look for alliances
  • North and South public and private
  • Create the conditions to conduct sustainable
    clinical research in, for and with the South
  • RD and development agendas
  • Prepare for success NOW

5
IAVI Sources of Funds
  • Governments ( 66)
  • Canada, The Netherlands, UK, US, Denmark, Sweden,
    Norway, Ireland
  • Multilateral ( 3)
  • World Bank
  • Private Foundations ( 30)
  • Bill Melinda Gates, Rockefeller, Alfred P.
    Sloan, Starr
  • Private sector ( 1)
  • Becton, Dickinson and company

6
IAVI Expenses 1996-2008
  • RD ? 77
  • Advocacy work ? 11
  • Administrative and general costs? 8
  • Fundraising ? 2
  • Political lobbying ? 2

7
IAVIs European NGO Partners
  • France AIDES
  • United Kingdom National AIDS Trust
  • Netherlands AIDS Fonds
  • Denmark AIDS Fondet
  • Germany Deutsche AIDS Stiftung
  • Spain gTt
  • Sweden Noahs Ark
  • Belgium Sensoa
  • Currently in preparation

8
Working with NGO partners
  • Information, education, awareness
  • Partners and/or IAVIs tools
  • Multilingual work? a must
  • Political work
  • Several levels (regional, national, EU, global)
  • Great diversity in-between countries
  • Clinical trials in Europe
  • IAVI as facilitator of community involvement
  • Ongoing cooperation? VGW trial countries

9
IAVI RD Activities in Europe
to be initiated
10
HIV vaccines approaches
recombinant protein
synthetic peptides (V3)
naked DNA
Viral, bacterial vectors
whole-inactivated virus
live-attenuated virus
11
What and to Whom?
  • A preventive AIDS vaccine will be given to
  • people uninfected with HIV to train their
  • immune systems to prevent infection or AIDS
  • There is no chance of any preventive vaccine now
    in clinical trials causing HIV infection because
    they contain only synthetic copies of portions of
    the virus, not the virus itself

12
Stages of vaccine researchPre-clinical
  • Biological idea/concept
  • Laboratory development
  • Construction of product? GLP
  • In parallel ? manufacturing (GMP) animal testing
  • Animal testing
  • Toxicity, immunogenicity
  • GLP and GMP identical

13
Stages of vaccine researchClinical
  • Phase I, preliminary
  • ndozens low risk of contracting HIV safety
  • Phase II, intermediate
  • n hundreds low and higher risk of contracting
    HIV more safety, immunogenecity, dosage,
    administration
  • Phase III, advanced
  • n thousands high risk of contracting HIV
    infection efficacy vs. placebo

14
Completed Trials UK
15
Ongoing Trials UK
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