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International AIDS Vaccine Initiative. UK CAB May 21, 2004 Maite Suárez, European Country Programmes Officer. IAVI. International, scientific, non for profit organisation HQ New York European office s in Amsterdam, working space in Brussels Offices in Nairobi and New Delhi
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International AIDS Vaccine Initiative UK CAB May 21, 2004 Maite Suárez, European Country Programmes Officer
IAVI • International, scientific, non for profit organisation • HQ New York • European offices in Amsterdam, working space in Brussels • Offices in Nairobi and New Delhi • IAVI’s 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
IAVI: Strategies • Accelerate R&D • 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
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 • R&D and development agendas • Prepare for success NOW
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
IAVI: Expenses 1996-2008 • R&D 77% • Advocacy work 11% • Administrative and general costs 8% • Fundraising 2% • Political lobbying 2%
IAVI’s European NGO Partners • France: AIDES • United Kingdom: National AIDS Trust • Netherlands: AIDS Fonds • Denmark: AIDS Fondet • Germany: Deutsche AIDS Stiftung • Spain: gTt • Sweden: Noah’s Ark • Belgium: Sensoa* * Currently in preparation
Working with NGO partners • Information, education, awareness • Partner´s and/or IAVI´s 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
IAVI R&D Activities in Europe * to be initiated
HIV vaccines approaches recombinant protein synthetic peptides (V3) naked DNA Viral, bacterial vectors whole-inactivated virus live-attenuated virus
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
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
Stages of vaccine researchClinical • Phase I, preliminary • n=dozens; 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