L'apport du laboratoire dans les essais cliniques vaccinaux

Vaccine clinical trials are of different nature, and their objectives are to generate the data in order to quality the safety and to document the efficacy of new vaccines or new mode of use of already existing vaccines. The laboratory is a contributor all along the excecution of these trials, either during the subject selection phase, either by delivering data on the biological reactogenicity of the vaccination, and finally (and in that case it is its main role) by documenting the pharmacodynamic effect of the vaccine which is to induce an immune response in the vaccinees. In some instances, the identification of an infectious agent will complete the added value of the laboratory. Biological samples are of diverse nature, but sera represent the majority of them. They have to be handled under strict conditions, and the technics implemented are diverse and have to follow constraining rules in order to guaranty the acceptance of the results by regulatory authorities to which they are submitted. The technics aiming at describing cellular mediated immunity are still at a research stage, and are not yet routinely used. One example of a global clinical immunology laboratory is described for a perspective vision.