Animal models for tuberculosis vaccine assays have evolved through a series
of sequential experiments aimed at optimizing the activity of a particular
vaccine product. As a result, studies that use different animal models do
not agree on the potency ranking of antituberculosis vaccines, and each maj
or test-system variable contributes to the disagreement. Disagreements amon
g laboratories about the efficacy of vaccines are in part due to difference
s in test systems. A survey of potency assays of tuberculosis vaccines sugg
ests that, based on the choice of a specific combination of variables in th
e test model, an investigator can show that any given Vaccine product has s
uperior potency. In view of these problems with animal models for research
on tuberculosis vaccines, we recommend that attention should be focused on
those animal models that replicate the key aspects of the natural history o
f human tuberculosis. The development of vaccines by means of new technolog
ies requires animal models to assay the protective potency of vaccines that
, ideally, inhibit tubercle bacilli at the point of infection. The developm
ent of new tuberculosis vaccines may be handled most efficiently in a joint
venture that includes both laboratories involved in vaccine production and
laboratories concerned with animal models.