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

Twenty-four hour after single or repeated injection, MIDGE-Th1 vector DNA was detected in almost all organs and tissues examined, suggesting that it was distributed systemically, most likely via the lymphatic system and the blood stream. A similar distribution pattern has been described for MIDGE-Th1 vectors Per day of sampling, five male and five female animals per group were killed. b Satellite group to assess biologic activity of the vaccine lot and induction of antibodies against dsDNA. Figure 2 . Immunogenicity of ascending LEISHDNAVAX doses in mice. Groups of 10 BALB/c mice (5 male, 5 female) were immunized i.d. at the tail base five times in weekly intervals with either PBS or LEISHDNAVAX (10, 50 or 100 μg per dose). Fourteen days after the last immunization LEISHDNAVAX-specific antibodies (total IgG) in sera were quantified by ELISA using plates coated with a mixture of recombinant LEISHDNAVAX antigens. ***P ⩽ 0.001 (Student's t-test); n.s.: not significant.