2
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.