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Laboratory Standardization

The Challenge: In the early stages of research, vaccine candidates are judged on their ability to stimulate immune responses in animals and humans. However, the laboratory assays that researchers use to assess immune response may not be comparable, severely hampering decisions about which candidates to pursue for further testing. In addition, new knowledge about the immune response to HIV is raising concerns that current assays overlook important aspects of those immune responses.

Recommendations: Important efforts are currently underway to standardize how laboratories conduct assays for measuring cellular immunity. The Enterprise scientific plan recommends that these efforts are expanded and extended to neutralizing antibody assays, with the ultimate goal of an international network of standardized laboratories. The plan also proposes that new research efforts be launched to create new immune response assays, and to test whether these assays can help researchers more accurately assess vaccine candidates' promise.

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