Experimental squalene adjuvant. II. Harmlessness and local reactogenity.

Abstract

Model experiments on laboratory animals (guinea pigs) were carried out to test the possible allergic reaction (possibility of sensitisation) to the repeated administration of an experimental lipoid adjuvant prepared on the basis of squalene (experimental squalene adjuvant--ESA). No significant differences were observed between the animals sensitised-provoked with ESA and control animals. In order to evaluate the local tissue reactivity (local reactogenity), also with regard to the process dynamics to the administration of ESA, comparative patho-anatomical and patho-histological examinations of tissues were carried out in the location of adjuvant administration. The examinations indicated very low local reactogenity of the experimental lipoid adjuvant prepared in our laboratory. The test of pyrogenicity also confirmed the safety of ESA, the labelled lysate sensitivity lambda was under 0.25 IU/cm3.