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