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STANDARDISATION OF HIV NEUTRALISATION ASSAYS TO BE USED IN VACCINE RESEARCH AND CLINICAL TRIALS

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The efficacy of viral vaccines can be confirmed by large sero-epidemiological studies where occurrence of a certain type(s) of functional antibody correlates with protection. In general, antibodies with virus neutralising function are the best correlates o f protection. Following this line of reasoning it is essential that the capacity of candidate HIV vaccines is tested for induction of functional (=neutralizing) antibodies, even if the role of neutralising antibodies in HIV infection and disease remains to be elucidated. Numerous in vitro neutralisation assays have been developed, each one with different variables and endpoints. NeutNet, a group of 13 participants from all over the world, proposes to co-ordinate activities aimed at standardising methods for the measurements of neutralising antibodies to HIV-1 for use in human clinical trials of candidate AIDS vaccines. NeutNet will organize these studies in several steps. First, an initial study will take place with all known neutralisation methods and a pan el of well-characterised and common reagents. The aim is to define appropriate assay(s) and reference controls for neutralisation assays. Second, on the basis of results obtained in the first study, a subsequent study will be performed with polyclonal ser ologic reagents. The aim is to gain understanding of the prerequisites of accurate and reproducible measurement of HIV-1 functional antibodies for HIV vaccine studies. A workshop jointly organized with WHO/UNAIDS will serve to discuss the results of the Ne utNet actions together with a larger body of workers in the field. The information thus obtained will be shared at a global level. The results of NeutNet will benefit HIV vaccine research and clinical trials making it possible to compare all vaccine effort s throughout Europe and beyond.

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FP6-2003-LIFESCIHEALTH-3
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