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

LEISHDNAVAX is well tolerated in L. donovani-infected mice Tolerability of LEISHDNAVAX and effects on visceral parasite burden were evaluated in BALB/c and C57BL/6 mice. Groups of mice infected with L. donovani were injected with one, two or three doses of 100 μg LEISHDNAVAX or PBS in weekly intervals. Parasite burden was evaluated seven days and 29 days after the last injection. No significant difference in hepatic or splenic parasite burden was found between groups receiving equal numbers of injections of PBS or LEISHDNAVAX. In both treatment groups infection with L. donovani followed the known kinetic 23 with distinct organ-specific growth patterns in livers and spleens of infected mice. Figure 3 shows the parasite burden as determined in the BALB/c and one C57BL/6 experiment.