International AIDS Vaccine Initiative UK CAB May 21, 2004 Maite Suárez, European Country Programmes...
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Transcript of International AIDS Vaccine Initiative UK CAB May 21, 2004 Maite Suárez, European Country Programmes...
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 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
HIV vaccines approachesrecombinant 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
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
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