international aids vaccine initiative uk cab may 21, 2004 maite suárez, european country programmes...
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International AIDS Vaccine Initiative
UK CAB May 21, 2004
Maite Suárez, European Country Programmes Officer
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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
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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
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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
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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
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IAVI: Expenses 1996-2008
• R&D 77%
• Advocacy work 11%
• Administrative and general costs 8%
• Fundraising 2%
• Political lobbying 2%
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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
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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
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IAVI R&D Activities in EuropeResearch Manufacturing Clinical Trials
Oxford, UK
Bioption, SW
Core lab, UK
Cobra, UK
IDT, DE
Berna, CH
St. Mary’s, London, UKSt. Thomas, London, UKOxford, UKSimbec, Wales, UK
GG&GD, NL*
CHUV, Lausanne, CH
Univ. Bonn, DEUniv. Hamburg, DE
St. Pieter ZH, Brussels, BESGS, Antwerp, BE
* to be initiated
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HIV vaccines approachesrecombinant protein
synthetic peptides (V3)
naked DNA
Viral, bacterial vectors
whole-inactivated virus
live-attenuated virus
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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
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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
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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
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Completed Trials UK
Study ID Sites Design # Dose/
Sched.
Status
#001 Oxford Single blind 18 2 x
0.1 or 0.5 mg DNA
Complete
#005 Oxford Open
Rollover
9 Late MVA boost of #001 volunteers
Complete
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Ongoing Trials UKStudy ID Sites Design #
volunteers
(Vac. / Pl)
Dose/Sched.
Status
#006
Prime/Boost
London and Oxford
DB, R, PC
Prime/day 0
EB (8/12w)–LB (20/24w)
120 Prime 0.5/2mg DNA; Boost
5x10e7
MVA
Vaccinations
Complete, trial compl. by Aug 04
#010
Prime/Boost
London
(Kenya)
DB, R, PCPrime (0/1m)
Boost (5/8m)
Route SC, IM, ID
111
(90/21)
Prime 0.5mg DNA; Boost
5x10e7 MVA
Enrolment complete
#011 Wales
(SA, CH, NL)
DB, R, PC
MVARoute 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