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Framework programme: 5
Project number:
EC contribution: € 2 500 000
Duration: 30 months
Type: DM
Starting date: 1 December 2002
Graphic element European Vaccine Effort Against HIV/AIDS – III
Keywords: HIV-1 vaccine; clade C; SFV; DNA; NYVAC; prime-boost; phase IIa clinical trial


The clinical lots for human use of the DNA, the Semliki Forest virus (SFV) and NYVAC 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. These vaccine components are provided by the EU cluster EuroVac and EU demonstration project EuroVac-II. One hundred HIV/AIDS low risk volunteers will be included in a phase IIa trial at four clinical trial sites.  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. Volunteers (50 each arm) will be immunised according to 0, 4, 8 and 12 weeks prime boost schedule.  Fifty will be immunised with two dosages (2 mg) of DNA as prime and two dosages (107 pfus) of NYVAC as boost. The other 50 will be immunised with two dosages of SFV (108 particles/dose) as prime and two dosages of NYVAC (107 pfus) as boost. 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.


A vaccine against HIV-1/AIDS is urgently needed to slow down the current epidemic in both Africa and Asia.  The predominant subtype of HIV-1 causing the AIDS epidemic in Africa and Asia is subtype C.


The aim is to induce T-cell immunity to gag, pol, nef and env HIV-1 proteins.

Expected results:

Identification of the best priming strategy, either SFV or DNA that, in combination with a standard dose of NYVAC, induces T-cell immunity.

Potential applications:

This project offers a unique opportunity to evaluate the efficacy of mixed immunisation schedules to induce strong and sustained T-cell immunity that represents a critical step for the development of an efficacious HIV vaccine.


Giuseppe Pantaleo
Laboratory of AIDS Immunopathogenesis
Department of Medicine
Centre Hospitalier Universitaire Vaudois
1011 Lausanne
Tel: +41 21 314 1071
Fax: +41 21 314 1070


Official Address Other Information
2Michel KleinAventis Pasteur
1541 Avenue Marcel Mérieux
FR-69280 Marcy l’Etoile
Tel: +33 4 37 37 33 71
Fax: +33 4 37 37 39 76
3Peter LiljeströmMicrobiology and Tumourbiology Centre
Karolinska Institutet
Nobels Väg 16
SE-171 77 Stockholm
Tel: +46 8 457 2550
Fax: +46 8 310 848
4Hans WolfInstitut für Medizinische Mikrobiologie und Hygiene
Universität Regensburg
Franz-Josef-Strauß Allee 11
DE-93053 Regensburg
Tel: +49 941 944 6400
Fax: +49 941 944 6402
5Jonathan N Weber and Francis GotchHead, Section of Infectious Diseases
Division of Medicine, Faculty of Medicine
Imperial College of Science, Technology and Medicine
St Mary’s Hospital, Norfolk Place
UK-W2 1PG London
United Kingdom
Tel: +44 207 594 3905
Fax: +44 207 594 3906
6William A. PaxtonDepartment of Human Retrovirology
Academisch Medisch Ziekenhuis bij de Universiteit van Amsterdam
Meibergdreef 15
NL-1105 AZ Amsterdam
The Netherlands
Tel: +31 20 5664739
Fax: +31 20 6916531
7R.A. CoutinhoMunicipal Health Service of Amsterdam
Nieuwe Achtergracht 100, PO Box 2200
NL-1000 CE Amsterdam
The Netherlands
Tel: +31 20 5555 5223
Fax: +31 20 5555 5775
8Sheena McCormackDivision of HIV and Infections
Medical Research Council Clinical Trials Unit
222 Euston Road
UK-NW1 2DA London
United Kingdom
Tel: +44 20 7670 4708
Fax: +44 20 7670 4815

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