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

Comparable distribution pattern after single or repeated administration Next, we tested whether repeated administration alters the distribution pattern or causes accumulation of vector DNA in tissues. One hundred and twenty micrograms of LEISHDNAVAX were administered to rats i.d. at the same site four times at weekly intervals. Vector DNA was quantified in total DNA extracted from tissue samples collected 24 h after the last injection. Distribution patterns and amounts of vector DNA were comparable 24 h after single and repeated injection (Figures 1a and b) . Copy numbers per μg total DNA ranged from 4.63 × 10 3 (geometric mean, lung tissue, 5/10 animals positive) to 4.50 × 10 7 (geometric mean, skin of injection site, all animals positive).