Preclinical safety and tolerability of a repeatedly administered human leishmaniasis DNA vaccine

Riede, O; Seifert, K; Oswald, D; Endmann, A; Hock, C; Winkler, A; Salguero, F J; Schroff, M; Croft, S L; Juhls, C

No significant difference in weights between PBS and LEISHDNAVAX-treated groups of mice was observed. Serum samples from mice, which had received three injections of PBS or LEISHDNAVAX, were subjected to analyses of standard biochemical parameters; alanine transaminase, aspartate aminotransferase, urea and creatinine. No significant differences between PBS and LEISHDNAVAX-treated groups were found for these parameters in BALB/c mice. Significant differences were found in levels of creatinine in C57BL/6 mice in two separate experiments. However, neither the time point nor the direction of difference were consistent between experiments ( Table 2) . Histological analysis of livers and spleens in repeated experiments and the kidney, heart and lung in a single experiment (C57BL/6 mice) revealed similar lesions in all animals (PBS and LEISHDNAVAX treated) in terms of location and severity. Lesions were consistent with infection and included severe granulomatous hepatitis and splenitis with intralesional parasites, granulomatous/interstitial pneumonia and interstitial nephritis and glomerulonephritis.