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European Vaccine Effort Against HIV/AIDS-II
Framework programme:
Project number:
EC contribution:
€ 3 000 000
36 months
Starting date:
1 November 2001

Keywords: AIDS vaccine; phase I HIV vaccine trial; SFV/DNA vaccine; HIV-1 subtypes B and C; prime-boost HIV vaccine


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.


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.

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