It is well established that ISCOMs function efficiently as an antigen-
presenting system and protective immunity has been evoked against a va
riety of infectious agents. The built-in saponin adjuvant from Quillaj
a saponaria Molina is responsible for the strong immunoenhancing activ
ity displayed by the ISCOM. However, to allow the use of ISCOMs in hum
an vaccines it is necessary to determine the immunological properties
and toxicity of chemically defined Quillaja components. Thus, the pres
ent study was carried out in a mouse model to determine the adjuvant a
ctivity and toxicity of ''free'', isolated Quillaja components, as wel
l as formulated into particles, i.e. ISCOM matrix. The purified Quilla
ja components and the ISCOM matrix formulations were examined for thei
r adjuvant activity in a model system consisting of purified influenza
virus antigen and Quillaja saponins. It was demonstrated that a Quill
aja component, designated QH-C, either as a ''free'' component or in a
n ISCOM matrix, has a strong adjuvant activity, but little or no toxic
ity in the doses tested. In addition, QH-C in the form of ISCOM matrix
does not induce any local reactions at the sire of injection. Thus, I
SCOMs containing the QH-C component, devoid of toxicity, but with stro
ng adjuvant activity, can prove to be useful in adjuvant formulations
for human use.