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Safety of attenuated smallpox vaccine LC16m8 in immunodeficient mice.
[severe combined immunodeficiency]
Freeze-dried
live
attenuated
smallpox
vaccine
LC
16
m
8
prepared
in
cell
culture
has
been
the
sole
smallpox
vaccine
licensed
in
Japan
since
1975
and
was
recently
recommended
as
a
WHO
stockpile
vaccine
.
We
evaluated
the
safety
of
recently
remanufactured
lots
of
LC
16
m
8
using
a
series
of
immunodeficient
mouse
models
.
These
models
included
suckling
mice
,
severe
combined
immunodeficiency
disease
(
SCID
)
mice
,
and
wild-
type
mice
treated
with
cyclosporine
.
LC
16
m
8
showed
extremely
low
virulence
in
each
of
the
three
mouse
models
compared
with
that
of
its
parental
strains
,
Lister
and
LC
16
mO
.
These
results
provide
further
evidence
that
LC
16
m
8
is
one
of
the
safest
replication-competent
smallpox
vaccines
in
the
world
and
may
be
considered
for
use
in
immunodeficient
patients
.
Diseases
Validation
Diseases presenting
"recently remanufactured lots"
symptom
severe combined immunodeficiency
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