Preclinical Biology
The primary goal of the Preclinical Biology group is to assess the suitability of combinations of potential antigens and their delivery vehicles (adjuvants and immunization strategy), which together make up a vaccine, for eliciting a protective immune response in vaccine recipients. For this purpose, the Preclinical Biology group studies what are called correlates of protection and correlates of disease, which are specific signs of infection and disease that can be measured in the laboratory to determine the effectiveness of a vaccine or chemotherapy. These correlates are followed using a combination of in vitro and in vivo studies. As an integral part of these efforts, assays are developed, as the need arises, for the purpose of determining the potency of candidate vaccine components.
Antigens with either prophylactic or therapeutic potential are being analyzed by the Preclinical Biology group. These candidate antigens have generally been developed at IDRI or in a collaborator's laboratory and often have been tested in small-scale trials before the Preclinical Biology group begins its work. The subsequent preclinical testing often uses larger-scale preparations of material from the Process Sciences group at IDRI. Using antigen and vaccine formulations prepared in-house, studies are performed to validate hypotheses about the safety of the vaccine, test the immunogenicity of candidate vaccines (i.e., the ability of a vaccine to generate an immune response), and analyze the immune correlates of protection (humoral and cellular immune responses, as appropriate) relating to the candidate vaccine. To perform these analyses and assess the histopathology of vaccinated and control groups, small animal studies are performed as a final part of the pre-clinical vaccine trials.
The Preclinical Group is available to partner with additional organizations for the purpose of analyzing promising candidate antigens, potential adjuvants, and vaccine delivery systems. Ideally, these vaccine studies will fit with the mission of IDRI: to treat infectious diseases of global significance, especially neglected diseases or those diseases for which a highly effective vaccine is still lacking. Because of their practical experience with assessing host immune responses and working with bacterial and parasitic diseases, the scientists at IDRI have the capability of working with and analyzing a wide range of compounds with clinical potential.