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EUROPRISE
HIV/AIDS
Framework programme: 6
Call: 4
Project number: LSHP-CT-2006-037611
EC contribution: € 15,500,000
Duration: 60 Months
Type: NoE
Starting date: 1 January 2007
Graphic element European Vaccines and Microbicides Enterprise
Keywords: HIV, AIDS, Vaccine, Microbicide, Mucosal, Network and Prevention

Summary:

The successful development of preventative strategies against HIV-1 infection (microbicides, vaccines or their combined effects) would provide a pivotal turning point in global efforts to combat the pandemic spread of AIDS providing an incalculable impact on solving societal prob-lems associated with this disease. The principal aim of this project is to bring together EU scien-tists from the microbicide and vaccine fields to embrace a co-ordinated approach to HIV-1 infec-tion prevention research. Partners in the EUROPRISE consortium represent 13 projects funded by the European Commission from the sixth Framework Programme as well as four projects funded by the Gates Foundation.

These projects involve 132 institutions from 22 countries. EUROPRISE is, in this respect, the first consortium to purposely bring these groups together in a truly integrated fashion from both within Europe and internationally. EUROPRISE will offer an integrated programme of research; co-ordinate a wide portfolio of activities and encompass the whole pipeline of vaccine and microbicide development; from early discovery, through to early clinical trials. This unique approach places the Network at the international forefront, for understanding the interface between these two technologies; pursuing a critical path to the develop-ment of effective HIV-1 infection prevention strategies.

Background:

Although therapeutics for HIV infection and AIDS continue to improve and initiatives for mak-ing these products available in developing countries have been introduced, ultimately, the global incidence of HIV infection is critically dependent on the development of safe and effec-tive strategies to block and prevent HIV transmission.

The design and implementation of effective microbicide and vaccine strategies, individually and possibly in combination, will be key to achieving this goal. Ideally, microbicides will pro-vide chemical and vaccines immune protection respectively, at the mucosal surfaces of the va-gina and rectum, which represent the major portals of viral entry. The combination of these approaches may maximise potential synergy between both technologies.

It is now well established that under most circumstances, vaccines delivering non-replicating antigens fail to induce sufficient mucosal responses and immunological memory to provide protection against high viral challenge. In contrast, while it may be technically easier to develop microbicides that prevent transmission when applied before intercourse, their duration of protection is likely to be short-lived and their efficacy will be critically dependent upon user compliance. To date, both fields have been slow to work together in the development of products that provide multiple levels of protection. This network is focusing on the premise that microbicides and vaccines that target multiple stages of mucosal transmission will have the best chance of success. Since both target the same proc-esses, there is a clear overlap between the two fields.

Indeed, there are compelling reasons as to why the two fields should work together on develop-ing effective strategies to prevent mucosal vaginal or rectal transmission including:

  1. Approximately 80% of new HIV infections are now heterosexual and the main portal of entry is across the vaginal or rectal mucosa. Local immunity at the site of infection is likely to be the most potent form of protection
  2. Topically applied products are likely to have a high level of acceptance. Importantly, their use would be female initiated. This is an important factor for women who have no means to protect themselves if their partners do not use male condoms or do not allow female condoms to be used
  3. Effective microbicides are likely to be available before effective vaccine candidates. Thus it is highly likely that in the not too distant future all vaccine efficacy trials will be carried out in an environment where there is widespread use of vaginal microbicides. Consequently, it will be important to understand the interaction and potential interface of these different prevention technologies. Furthermore, microbicides, if successfully introduced, may pro-vide an established route for vaginal delivery of formulations designed to stimulate and/or activate protective immunity. The future combination of strategies developed in this pro-gramme - either through crossover of microbicide and vaccine use in common populations or as a result of a deliberate strategy to develop a combined vaccine-microbicide modality - has the potential to maximise the protective effects of both strategies.

Aim:

The successful development of preventative strategies against HIV-1 (microbicides, vaccines or their combined effects) would provide a pivotal turning point in global efforts to combat the pandemic spread of AIDS providing an incalculable impact on solving societal problems asso-ciated with this disease. The principal aim of this proposal is to bring together EU scientists from the microbicide and vaccine fields to embrace a coordinated approach to HIV-1 preven-tion research.

Delivery of the goals will be achieved through the following scientific and technical objectives:

  1. Standardisation and harmonisation of research tools
  2. Identification of new anti-HIV INFECTION AND AIDS vaccine and microbicide candi-dates and combinations to prevent HIV infection /AIDS
  3. Establishment of a clinical development pathway for vaccines and microbicides within a European framework
  4. Provision of Scientific training in microbicide and vaccine development
  5. To facilitate access to information relevant to HIV-1 microbicides and vaccines
  6. Provision of a single focus for European HIV-1 microbicide and vaccine research.

Expected results:

  1. Standardisation and harmonisation of research tools as applied to basic, animal and clinical research and related to microbicides and vaccines. Verifiable aspects will be the develop-ment of core protocols, provision of standardised reagents and the establishment of a quality assurance programme
  2. The development of a portfolio of existing and new prevention candidates (vaccines, micro-bicides and combinations) that can be evaluated on a one-on-one basis to prioritise the most promising leads for progression into translational clinical research. Verifiable indicators will be the development of an evolving portfolio of prevention candidates and their progress through preclinical evaluation
  3. Provision of an accessible toolbox to support the translation of HIV-1 vaccine or microbi-cidal products from basic research in the European Research Area (ERA) into clinical trials. Verifiable indicators will be the accessibility and utility of the translational toolbox
  4. The increased integration of European research in the fields of HIV-1 vaccine and microbi-cide research. Verifiable indicators will be seen through workshop, conference attendance, scientific exchange and attainment of high degrees
  5. The development of an Internet resource that will be used by EUROPRISE participants and the scientific community. Verifiable indicators will be the utility and maintenance of the EUROPRISE website
  6. Effective integration and identity of European microbicide and vaccine research. Verifiable indicators will view: an increase in collaborative research; publications; new joint research proposals; active engagement of community groups; and strong international representation of EU HIV prevention (conferences, expert panels, advisory boards, and publication of con-sensus documents).

Potential applications:

The potential strategic impact on solving societal problems for any project aimed at developing a preventative strategy against HIV infection /AIDS (microbicides or vaccines) is almost incal-culable. HIV infection /AIDS is a global issue and UNAIDS/WHO estimate that at the end of 2004, 40 million people globally were living with HIV, of which 28.5 million were in Sub- Saharan Africa. In Eastern Europe and Central Asia, a rapid increase in HIV infections resulted in 1.4 million people being affected. InWestern Europe, an estimated 610,000 people were liv-ing with HIV.

Globally, there are 14,000 new HIV infections per day, of which 95% are in developing coun-tries. Approximately 12,000 of these infections are in persons aged 15-49 years of age, of whom almost 50% are women, and 50% are 15-24 years of age. In S. Africa, 1 in 4 women are infected with HIV by the age of 22.

It has been estimated that a 60% efficacious prophylactic treatment, introduced into 73 low-income countries and used by only 20% of women, would avert 2.5 million HIV infections over a period of 3 years in women, men and infants.

In some countries, public health programmes have achieved modest results in reducing HIV rates of infection. Although the use of condoms has slowly increased in countries most severely affected by the HIV epidemic, many vulnerable women are unable to ensure routine use.

The development of new anti-HIV infection and AIDS vaccines and microbicides has been identified as key areas in FP6. This builds on past highquality research programmes on vac-cines and therapeutics supported by the EU, through the programmes FP4 and FP5. However, while significant progress has been achieved in understanding immune response to HIV-1 antigens and in the development of effective antiretroviral therapy, significant challenges to the development of effective preventative strategies still remain. The potential direct impact of this network, therefore, is multifaceted and broad in scope. There is a clear and urgent need to network European microbicide and vaccine research and provide a clear and coordinated strategy for the development of new prevention technology against HIV infection and AIDS.

Such an approach has obvious potential for direct health benefits that will translate into social stability and development. It will offer scientific benefits; by the creation of new knowledge as well as maintaining a strong science base in Europe. It is generally accepted that HIV vaccines and microbicides will have the most significant impact on the growth of this pandemic in both the developing world and within Europe. The potential to derive enormous health benefits, by itself, argues for a strong, integrated approach to the development of HIV-1 prevention strate-gies.

Coordinator:

1 - Administrative Coordinator:
Robin Shattock
Centre for Infection Department of Cellular and Molecular Diseases
St George’s Hospital Medical School
Cranmer Terrace / Tooting, London
SW17 ORE
United Kingdom
Tel: +2087255855
Fax: +2087253487
E-mail: shattock@sgul.ac.uk

2 - Scientific Coordinator:
Hans Wigzell Karolinska Institutet
Stockholm - Sweden
E-mail: hans.wigzell@mtc.ki.se

3 - Co-Coordinator for Vaccines:
Rino Rappuoli
Novartis Vaccines and Diagnostics srl
Via Fiorentina 1
53100 SIENA - Italy
E-mail: rino_rappuoli@chiron.com

Partners:

Principal
Scientific
Participants
Official Address Other Information
4R Shattock / Dr M Cranage
J Ma / Dr D Lewis
St. George’s Hospital University of London
London
UK
5H Wigzell / Dr BWahren / Dr F Chiodi
A-L Spetz
Karolinska Institutet
Stockholm
SE
6R Rappuoli / Dr S Barnett
G Del Giudice
Novartis Vaccines and Diagnostics
Siena
IT
7D Medaglini / Prof G PozziUniversita di Siena
Siena
IT
8A TagliabueALTA Siena IT
9G VossGlaxoSmith Kline
Rixensart
BE
10H Katinger / G SteiglerePolymun
Vienna
AT
11C Kelly / T Lehner
L Klavinskis
Kings College London
London
UK
12G ScalaeUniversita di Napoli
Naples
IT
13K UberlaRuhr Universitaet Bochum
Bochum
DE
14H Holmes / N. Almond
R Stebbingse
National Biological Standards Board
Potters Bar
UK
15R WeissUniversity College London
London
UK
16F Gotch / S PattersonImperial College of Science,
Technology & Medicine
London
UK
17V JespersPrince Leopold Institute
for Tropical Medicine
Antwerp
BE
18S McCormack / A Nunn
J Bakobaki
Medical Research Council
London
UK
19G Scarlatti / G Poli / P LussoCentro San Raffaele
Milan
IT
20R Le GrandCommissariat a l’Energie Atomique
Paris
FR
21B Verrier
C Lacey
Institut National de la Sante et de la Medecine
FR
University of York
York
UK
22Q SattentauUniversity of Oxford
Oxford
UK
23P La CollaUniversità di Cagliari
Cagliari
IT
24Christiane Stahl-HennigDeutsches Primatenzentrum GmbH Goettingen
DE
25FenyöLunds Universitet
Lund
SE
26F TangyInstitut Pasteur
Paris
FR
27H SchuitemakerSanquin
Amsterdam
NL
28J Alcami / Prof R NajeraInstituto de Salus Carlos III
Majadahonda
ES
29G Leroux-RoelsGhent University
Ghent
BE
30D ZipetoUniversità di Verona
Verona
IT
31S NorleyRobert Koch-Institut
Berlin DE
32E KaramovIvanovsky Institute of Virology,
Russian Academy of Medical Science
Moscow
Russia
33K NihlmarkMabtech AB
Stockholm
SE
34N DedesEuropean AIDS Treatment Group e.V
Dusseldorf
DE
35 C MoogUniversite Louis Pasteur
Strasbourg
FR

 
 
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