Modified vaccinia virus Ankara (MVA)-based recombinant viruses have been sh
own to be potent vaccine candidates for several infectious and neoplastic d
iseases. Since a major application of these live, replication-deficient vec
tors would be their use in immunocompromised or potentially immunocompromis
ed individuals. a preclinical safety study was carried out. Macaques were i
noculated with high doses of MVA (10(9)) via various routes. after immune-s
uppression by total-body irradiation, anti-thymocyte globulin treatment, or
measles virus (MV) infection. No clinical, haematological or pathological
abnormalities related to MVA inoculation were observed during a 13-day foll
ow-up period. The presence of MVA genomes was demonstrated by nested PCR du
ring the course of the experiment in ail macaques. but from none of these a
nimals replication competent MVA could be reisolated. These data suggest th
at MVA can safely be used as a basis for recombinant human vaccines, and th
at it is also safe for use in immunocompromised individuals. (C) 2001 Elsev
ier Science Ltd. All rights reserved.