Abstract
Summary
Long-term observations up to 24 months in guinea pigs and 39 months in monkeys given multiple doses of emulsified preparations of adjuvant 65 or their aqueous counterparts were carried out. Extensive gross and microscopic pathologic observations of the major organs and tissues were made. Aside from local reactions at the injection site, there was no evidence for immunopathologic lesions, disseminated granulomatous lesions, tumor formation, or other pathologic processes referable to the vaccine. The local reactions observed were those to be expected following the injection of nonirritating and metabolizable fatty materials, viz., lipoid granulomata with gradual disappearance of oil cysts, residual collection of phagocytic cells, and final disappearance of reactions after some months. There was no evidence that adjuvant 65 would be likely to cause abscess or nodule formation. A test for teratogenicity in rabbits given adjuvant 65 emulsified preparations, or their aqueous counterparts on the eighth day of pregnancy revealed no apparent effects on fetal development.
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