Considerations about the design for the toxicological evaluations required in a novel vaccine adjuvant

The toxicologics studies of novel adjuvants vaccine, they should be carried out according to the recommendations of the lines guidelines of the Organization for the Cooperation and Development (OECD) and European Medicines Agency (EMEA). In our days its stands out the adjuvants use in most of the vaccine candidates, as enhancers of the immune response, but in general the adjuvants existen, presents adverse and undesirable effects, mainly of toxic nature, results that they have been good to affirm for several experts and studious of this matter that for them the ideal adjuvant doesn't exist. This review has as objective to carry out a design for the toxicological evaluations required in a novel vaccine adjuvant. We kept in mind the assays to determine the toxicity for unique dose, for repeated dose, local tolerance, evaluations of reproduction toxicology, special toxicology which includes genotoxicity and mutagenesis, and lastly the pyrogen assay. They are numerous the evaluations to carry out to be able to register and to validate a novel adjuvant, which allow determining the toxic effect at all the possible levels, this to our approach has been to diminish the risk to undesirable effects of the vaccines used in human and animals.