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 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

3. 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

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 R&D 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 R&D  77% Advocacy work  11% Administrative and general costs  8% Fundraising  2% Political lobbying  2%

7. 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

8. 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

9. IAVI R&D Activities in Europe ResearchManufacturingClinical Trials Oxford, UK Bioption, SW Core lab, UK Cobra, UK IDT, DE Berna, CH St. Mary’s, London, UK St. Thomas, London, UK Oxford, UK Simbec, Wales, UK GG&GD, NL * CHUV, Lausanne, CH Univ. Bonn, DE Univ. Hamburg, DE St. Pieter ZH, Brussels, BE SGS, Antwerp, BE * 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 research Pre-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 research Clinical 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

14. Completed Trials UK Study IDSitesDesign#Dose/ Sched. Status #001OxfordSingle blind182 x 0.1 or 0.5 mg DNA Complete #005OxfordOpen Rollover 9Late MVA boost of #001 volunteers Complete

15. Ongoing Trials UK Study IDSitesDesign# volunteers (Vac. / Pl) Dose/Sched. Status #006 Prime/Boos t London and Oxford DB, R, PC Prime/day 0 EB (8/12w)– LB (20/24w) 120Prime 0.5/2mg DNA; Boost 5x10e7 MVA Vaccination s Complete, trial compl. by Aug 04 #010 Prime/Boos t London (Kenya) DB, R, PC Prime (0/1m) Boost (5/8m) Route SC, IM, ID 111 (90/21) Prime 0.5mg DNA; Boost 5x10e7 MVA Enrolment complete #011Wales (SA, CH, NL) DB, R, PC MVA Route SC, IM, ID 111 (90/21) MVA dose escalation till 2.5x10e8 low and mid dose enrolment compl. #016 Oxford DB, R, PC MVA DNA/MVA 24 (16/8) Day 0,28,56 MVA 1x10e8 DNA 4 mg 12 volunteers enroled