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THERAVAC
HIV/AIDS
Framework programme: 5
Project number:
QLK2-CT-2002-01299
EC contribution: € 3 000 000
Duration: 48 months
Type: RS
Starting date: October 2002
Graphic element Evaluation of a Therapeutic Vaccination Strategy for HIV-1 Infection TheraVac
Keywords: HIV-Vaccines; antiretroviral therapy; CD4 T cells to HIV CD8 T cell to HIV; reccombinant attenuated pox virus; NYVAC- MVA – ELISPOT

Summary:

Highly active antiretroviral therapy (HAART) dramatically decreases in HIV-related morbidity but does not eradicate HIV and is associated with severe toxicities. Lifelong therapy with antiretroviral agents in HIV infection is not possible for reasons of toxicity. Therapy interruptions are common but are limited by virus relapses. A strategy that would significantly prolong therapy interruptions is the only option for long-term management of HIV infection.

Expected results:

A principal deliverable of TheraVac is to show that the combination of the two new vaccines produced in Europe with antiretrovirals can limit time on therapy. Such a strategy should decrease the antiretroviral drug toxicity and cost for the European community.

Aims:

The objectives of TheraVac are to demonstrate the following in phase I/II clinical trials on HIV-infected patients successfully treated with HAART:

1) the safety of new highly attenuated NYVAC and MVA HIV-recombinant vaccines produced in clinical grade conditions by  EuroVac
2) their ability to restore the immune control of HIV and to increase numbers and breadth of HIV-specific T cells measured by using a European standard ELIspot assay for monitoring T-cell responses
3) the vaccine efficacy based on their ability to allow HAART interruptions for prolonged periods of time by controlling virus replication and protecting against CD4 cell depletion.

Potential application:

The evaluation of the safety, the immunogenicity and the protective efficacy of new, potent European vaccines in a randomised clinical trial will define new strategies for the optimal use of antiretroviral agents by limiting the requirement for expensive and toxic antiretroviral drugs. This will have a major impact on the cost of the HIV infection, not only for the European Community but also for the developing countries, as mentioned in the G8 Decisions from July 2001.

Coordinator:

Brigitte Autran
Laboratoire d’Immunologie Cellulaire et Tissulaire
Bâtiment CERVI
Hôpital Pitié-Salpêtrière
83 Boulevard de l’Hôpital
75651 Paris Cedex 13
France
Tel: +33 1 42 17 74 03
Fax: +33 1 42 17 74 90
E-mail: brigitte.autran@psl.ap-hop-paris.fr

Partners:

Principal
Scientific
Participants
Official Address Other Information
2Dominique CostagliolaINSERM SC4
56, Boulevard Vincent Auriol
FR-75013 Paris
France
Tel: +33 1 42 16 42 82
Fax: +33 1 42 16 42 61
E-mail: dominique.costagliola@ccde.chups.jussieu.fr
3Joep LangeDepartment of Human Retrovirology
Academish Ziekenhuis bijde Universiteit van Amsterdam
Meibergdreef 15
NL-1105 AZ Amsterdam
The Netherlands
Tel: +31 20 566 3349 / 7835 / 4041
Mobile: +31 62 054 3374
Fax: +31 20 691 8821
E-mail: j.lange@amc.uva.nl
4Frank MiedemaCentral Laboratory of Netherlands’ Red Cross
Blood Transfusion Service
Plesmanlaan 125, Box 9190
NL-1006 AD Amsterdam
The Netherlands
Tel: +31 20 512 3317
Fax: +31 20 512 3310
E-mail: F_Miedema@clb.nl
5Giuseppe PantaleoLaboratory of AIDS Immunopathogenesis
Department of Medicine
Centre Hospitalier Universitaire Vaudois
Av. De Beaumont 29, Hopital Beaumont
Ch–1011 Lausanne
Switzerland
Tel: +41 21 314 0802
Fax: +41 21 314 0801
E-mail: giuseppe.pantaleo@chuv.hospvd.ch
6Christine KatlamaService des Maladies Infectieuses
Pavillon Laveran
Hôpital Pitié-Salpêtrière
83, Boulevard de l’Hôpital
FR-75651 Paris Cedex 13
France
Tel: +33 1 42 16 01 42
Fax: +33 1 42 16 0126
E-mail: christine.katlama@psl.ap-hop-paris.fr
7Hans J. WolfInstitute of Medical Microbiology and Hygiene
University Regensburg
Franz-Josef-Strauss Allee, 11
DE-93053 Regensburg
Germany
Tel: +49 941 944 6401 / +49 171 242 2075
Fax: +49 941 944 6402
E-mail: hans.wolf@klinik.uni-regensburg.de
8Marie-Joëlle Frachette, Michel KleinR&D Office
Aventis Pasteur
1541,Avenue Marcel Mérieux
FR-69280 Marcy l’Etoile
France
Tel: +33 4 37 37 33 71
Fax: +33 4 37 37 30 28
E-mail: michel.klein@aventis.com
Tel: +33 4 37 37 94 66
Fax: +33 4 37 37 30 28
E-mail: Marie-Joelle.Frachette@aventis.com
9Roger LegrandService de Neurovirologie
Commissariat à l'Energie Atomique
DSV/DRM
BP6
60-68 Av. Div. Leclerc
FR-92 265 Fontenay-Aux-Roses Cedex
France
Tel: +33 1 46 54 73 74
Fax: +33 1 46 54 77 26
E-mail: legrand@dsvidf.cea.fr
10Susan CLARKERegulatory Affairs Advisor, LibraPharm
Gemini House
162 Craven Road
UK-RG14 5NR Newbury
United Kingdom
Tel: +44 (0) 1635 522651
Fax: + 44 1635 230271
E-mail: clarkesue@librareg.demon.co.uk

 
 
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