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Hyper-attenuated MTBVAC erp mutant protects against tuberculosis in mice.
[severe combined immunodeficiency]
Safety
of
individuals
at
risk
of
immune
suppression
is
an
important
concern
for
live
vaccines
.
The
new-generation
tuberculosis
vaccine
candidate
MTBVAC
,
a
genetically
engineered
doubly
attenuated
Mycobacterium
tuberculosis
mutant
with
deletions
in
phoP
and
fadD
26
virulence
genes
has
demonstrated
comparable
safety
in
different
relevant
animal
models
and
superior
protection
in
mice
as
compared
to
the
only
currently
licensed
tuberculosis
vaccine
Mycobacterium
bovis
BCG
.
Here
we
describe
the
construction
of
a
highly
attenuated
MTBVAC-based
live
vaccine
by
an
additional
gene
inactivation
generated
in
erp
of
MTBVAC
.
The
gene
product
of
erp
is
an
exported
repeated
protein
(
Erp
)
,
a
virulence
factor
described
to
be
involved
in
intracellular
replication
of
M
.
tuberculosis
.
The
resultant
strain
,
MTBVAC
erp
(
-
)
,
was
tested
in
severe
combined
immunodeficiency
(
SCID
)
mouse
model
showing
to
be
severely
attenuated
when
compared
to
BCG
and
MTBVAC
.
Experiments
conducted
in
immunocompetent
mice
revealed
that
the
hyper-attenuated
profile
observed
with
MTBVAC
erp
(
-
)
strain
did
not
compromise
its
protective
efficacy
profile
in
comparison
with
BCG
.
These
results
postulate
MTBVAC
erp
(
-
)
as
a
potential
tuberculosis
vaccine
candidate
for
use
in
high
-risk
populations
of
immune
suppression
(
e
.
g
.
,
due
to
HIV
infection
)
,
where
the
use
of
BCG
is
not
recommended
.