E. Dragunsky et al., A POLIOVIRUS-SUSCEPTIBLE TRANSGENIC MOUSE MODEL AS A POSSIBLE REPLACEMENT FOR THE MONKEY NEUROVIRULENCE TEST OF ORAL POLIOVIRUS VACCINE, Biologicals, 24(2), 1996, pp. 77-86
Two poliovirus-susceptible transgenic mouse (Tg PVR) strains, Tg1 and
Tg21, were compared with the monkey test for their sensitivity to neur
ovirulence of live oral poliovirus vaccine (OPV). Intracerebral (i.c.)
and intraspinal (i.s.) routes of inoculation were investigated to det
ermine the most suitable combination of mouse strain and route. Evalua
tion of the mouse tests was performed using several indicators; clinic
al score and failure time were selected as the most efficient. Tg1 and
Tg21 mice inoculated i.s. with type 2, and Tg21 mice inoculated i.s,
with type 3 OPV were determined to be the most appropriate systems, wh
ereas they are shown not to be suitable for type 1 OPV. The sensitivit
y of each of the two mouse models was at least equal to that of the mo
nkey test, suggesting that these mouse systems might be considered as
a potential replacement for the monkey test of OPV. However, more data
are needed to establish regulatory criteria of acceptability for vacc
ine lots tested in Tg PVR mice. This is the first study conducted with
Tg PVR mice with ail three types of poliovirus vaccine preparations.
(C) 1996 The International Association of Biological Standardization