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EUROVAC II
HIV/AIDS
Framework programme: 5
Project number:
QLK2-CT-2001-01316
EC contribution: € 3 000 000
Duration: 36 months
Type: DM
Starting date: 1 November 2001
Graphic element European Vaccine Effort Against HIV/AIDS-II
Keywords: AIDS vaccine; phase I HIV vaccine trial; SFV/DNA vaccine; HIV-1 subtypes B and C; prime-boost HIV vaccine

Summary:

The primary objective of EuroVac-II is to demonstrate, in a phase I trial of humans, the relative capacity of DNA vs SFV containing gag, pol, nef and env genes to prime T- and B-cell responses to HIV-1, either in combination with rgp140 or with poxvirus vectors + rgp140.  The study design will allow for a head-to-head comparison of the safety of SFV and DNA and of the ability of these two vaccine delivery methods to prime the immune response upon boosting by poxvirus (NYVAC) and/or recombinant gp140.

Description:

First clinical lots for human use of the DNA and the Semliki Forest virus (SFV) vaccine components with inserts of the HIV-1 subtype C gag, pol, nef and env genes will be produced adhering to GMP and GLP guidelines.  The other two vaccine components, NYVAC and recombinant gp140 derived from the same HIV-1 subtype C primary isolate, are provided by the EU cluster EuroVac.

Eighty HIV/AIDS low-risk volunteers will be included in a phase I trial at two clinical trial sites.  Immunisation, blood and lymph node sampling, and laboratory testing will be done strictly according to the agreed protocol.  All data will be taken to a single database for quality assurance and analysis.  Repositories and databases will be set up to assure that clinical samples will be handled appropriately, documented prudently and analysed accurately. Results from standardised and validated assays will be used as readouts for primary end-points of the trials.

The technologies of choice for CD8+ CTL assays are firstly, the ELISPOT assay using pooled peptides and secondly, tests for tetramer staining.  The technologies of choice for CD4+ T-cell help assays are firstly the ELISPOT assay, again using pooled peptides and secondly antigen-specific proliferative responses using a panel of peptides.  These assays will be done on peripheral mononuclear blood cells and lymph node aspirate.  The B-cell responses to the different vaccine regimes will be evaluated using HIV-1 env binding, neutralisation and fusion-inhibiting assays. The association of anti-HIV immune responses with the expression of chemokines, chemokine receptors and cytokines will be evaluated.

Coordinator:

Peter Liljeström
Microbiology and Tumourbiology Centre
Karolinska Institutet
Nobels Väg 16
171 77 Stockholm
Sweden
Tel: +46 8 457 2550
Fax: +46 8 310 848
E-mail: peter.liljestrom@mtc.ki.se

Partners:

Principal
Scientific
Participants
Official Address Other Information
2Marc GirardUMR 2142 CNRS-BioMérieux
ENSL
FR-Lyon
France
3William PaxtonDepartment of Human Retrovirology
Academisch Ziekenhuis bij de Universiteit van Amsterdam
NL-Amsterdam
The Netherlands
4Michel KleinR&D Office
Aventis Pasteur
FR-Marcy l’Etoile
France
5Paolo LussoDIBIT Unit of Human Virology
Fondazione Centro San Raffaele del Monte Tabor
IT-Milan
Italy
6Hans J. Wolf/Ralf WagnerInstitute of Medical Microbiology and Hygiene
University Regensburg
DE-Regensburg
Germany
7Sheena McCormackClinical Trials Unit
HIV Division
Medical Research Council
UK-London
United Kingdom
8Christiane MoogUnité INSERM 74 sur la Pathogénie des Infections Virales Persistantes
Institut Nationale de la Santé et de la Recherche Médicale
FR-Strasbourg
France
9Giuseppe PantaleoLaboratory of AIDS Immunopathogenesis
Department of Medicine
Centre Hospitalier Universitaire Vaudois
Lausanne
Switzerland
10Quentin SattentauDepartment of Infectious Diseases
Imperial College School of Medicine
London
United Kingdom
11Jonathan Norden WeberDepartment of Infectious Diseases
Imperial College School of Medicine
London
United Kingdom

 
 
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