Date: Sep 16, 2013 Source: (
click here to go to the source)
An
NIAID
‐
conducted
Phase
1
Study
Will
Assess
the
Safety
and
Immunogenicity
of
the
Profectus
Multi
‐
Antigen
HIV
DNA
Vaccine
in
Formulation
with
Profectus'
GENEVAX™
IL
‐
12
Adjuvant
when
Delivered
by
Electroporation
to
prime
the
immune
response
followed
by
booster
immunization
with
the
Profectus
recombinant
Vesicular
Stomatitis
Virus
(rVSV)
‐
Vectored
HIV
Vaccine
in
HIV
‐
infected
Adults
on
Antiretroviral
Therapy.
In
addition,
the
ability
of
the
"prime
boost"
vaccination
regimen
to
address
the
goals
of
the
HIV
cure
agenda
by
targeting
the
latent
reservoir
and
eradicating
HIV
will
be
evaluated.
Baltimore, MD -- September 16, 2013
--
Profectus
BioSciences,
Inc.,
a
developer
of
the
next
generation
of
vaccines
addressing
high
‐
value
unmet
indications
in
biodefense,
infectious
and
emerging
diseases,
announced
today
the
initiation
of
a
phase
1
study
evaluating
the
safety
and
immunogenicity
of
a
therapeutic
HIV
vaccine
strategy.
HIV
‐
infected
adults
on
stable
antiretroviral
therapy
(ART)
will
receive
the
Profectus
multi
‐
antigen
HIV
plasmid
DNA
(MAg
‐
pDNA:
env
,
gag
,
pol
,
nef
,
tat
and
vif
)
vaccine
administered
with
the
Profectus
GENEVAX™
interleukin
‐
12
(IL
‐
12)
pDNA
adjuvant,
delivered
using
the
TriGrid™
electroporation
(EP)
delivery
system
licensed
from
Ichor
Medical
Systems,
as
a
priming
vaccine.
This
will
be
followed
by
booster
immunization
with
the
Profectus
recombinant
vesicular
stomatitis
virus
(rVSV)
‐
vectored
HIV
vaccine
delivered
by
intramuscular
injection.
The
randomized,
double
‐
blind,
placebo
‐
controlled
study
is
in
support
of
the
HIV
Cure
Agenda
and
is
being
sponsored
by
the
National
Institute
of
Allergy
and
Infectious
Diseases
(NIAID),
part
of
the
National
Institutes
of
Health.
The
study,
which
will
enroll
30
HIV
‐
infected
adults,
is
being
conducted
by
NIAID's
Dr.
Michael
Sneller
under
a
protocol
designated
Theravax
13
‐
I
‐
0141.
Pre
‐
clinical
studies
conducted
by
Profectus
have
demonstrated
that
the
prime
‐
boost
delivery
of
the
HIV
pDNA
and
HIV
rVSV
vaccines
results
in
an
HIV
‐
specific
cell
‐
mediated
immune
(CMI)
response
of
significantly
increased
magnitude
and
functionality
as
compared
to
delivery
of
the
HIV
pDNA
or
HIV
rVSV
vaccines
alone.
To
address
the
goals
of
the
HIV
Cure
Agenda
the
effect
of
vaccination
on
the
rate
of
decay
of
the
HIV
‐
infected,
CD4+
T
‐
cell
reservoir
and
the
effect
on
rebound
viremia
following
analytical
treatment
interruption
will
also
be
tested.
Dr.
John
Eldridge,
Profectus
BioSciences'
Chief
Scientific
Officer,
said:
"Everyone
at
Profectus
is
very
pleased
to
continue
our
collaboration
with
NIAID
in
the
development
of
a
vaccine
to
treat
HIV
infection.
While
current
antiretroviral
therapy
is
wonderfully
effective
at
controlling
HIV,
unfortunately,
we
know
that
stopping
antiretroviral
therapy
results
in
a
rapid
return
of
high
level
HIV
into
the
bloodstream.
Therefore,
Profectus
Biosciences
is
committed
to
the
development
of
therapeutic
strategies
aimed
at
destroying
persistently
infected
cells
with
the
ultimate
goal
of
eradicating
HIV
in
infected
individuals
receiving
ART.
As
a
first
step
toward
"the
cure,"
in
this
clinical
trial
we
will
investigate
the
effect
of
our
prime
‐
boost
therapeutic
vaccination
strategy
on
the
decay
of
the
persistent
HIV
reservoir
in
infected
individuals
who
initiated
ART
during
the
early/acute
phase
of
HIV
infection.
This
trial
represents
an
early
step
towards
the
ultimate
goal
of
eradication
or
drug
‐
free
control
of
HIV
infection."
The
Theravax
13
‐
I
‐
0141
study
will
build
upon
promising
results
seen
in
other
clinical
trials
of
the
Profectus
MAg
‐
HIV
pDNA
and
HIV
rVSV
vaccine
candidates:
•
In
HVTN
‐
080
,
a
fixed
dose
level
of
GENEVAX™
IL
‐
12
pDNA
was
evaluated
for
its
ability
to
augment
immune
responses
to
an
experimental
HIV
pDNA
vaccine
delivered
with
EP
in
HIV
‐
negative
volunteers.
The
final
data
show
that
GENEVAX™
IL
‐
12
pDNA
delivered
with
EP
is
safe
and
significantly
increases
the
percentage
of
vaccine
recipients
that
mount
a
CMI
response
as
compared
to
the
HIV
pDNA
alone.
In
addition
to
improving
the
response
rate,
the
inclusion
of
IL
‐
12
DNA
also
lessened
injection
site
discomfort.
•
In
ACTG
‐
5281
,
a
fixed
dose
of
the
Profectus
HIV
MAg
‐
DNA
vaccine
with
low,
intermediate
or
high
doses
of
GENEVAX™
IL
‐
12
pDNA
adjuvant
delivered
with
the
TriGrid™
device
is
being
evaluated
in
HIV
‐
infected
subjects
on
stable
anti
‐
retroviral
therapy.
This
placebo
‐
controlled,
dose
‐
escalation
study
is
being
conducted
by
the
NIAID
‐
funded
AIDS
Clinical
Trials
Group
at
14
sites
in
the
US
and
has
fully
enrolled
60/60
subjects.
No
safety
issues
have
been
noted,
and
immunologic
assessment
of
the
groups
receiving
the
no
and
low
doses
of
GENEVAX™
IL
‐
12
have
confirmed
CMI
responses
in
a
subset
of
participants.
•
In
IAVI
‐
B004
,
a
fixed
priming
dose
of
the
Profectus
HIV
MAg
‐
pDNA
vaccine
with
various
dose
levels
of
GENEVAX™
IL
‐
12
pDNA
adjuvant
delivered
with
the
TriGrid™
device,
followed
by
booster
immunization
with
a
recombinant
serotype
35
adenovirus
delivering
HIV
gag
,
rt
,
int
and
env
(rAd35
GRIN/ENV)
was
evaluated
in
HIV
‐
negative
volunteers.
This
placebo
‐
controlled
study
was
sponsored
by
the
International
AIDS
Vaccine
Initiative
(IAVI)
and
conducted
in
collaboration
with
three
clinical
research
partners
in
Africa
enrolling
75
subjects.
No
safety
issues
have
been
noted.
For
more
information
about
IAVI,
please
visit
www.iavi.org.
•
In
HVTN
‐
090
,
five
dose
levels
of
the
Profectus
rVSV
‐
vectored
HIV
vaccine
delivered
by
intramuscular
injection
were
tested
for
safety
and
immunogenicity
in
HIV
‐
negative
volunteers.
This
placebo
‐
controlled
study
has
fully
enrolled
60/60
subjects
at
four
clinical
sites.
Results
from
this
study
confirm
that
the
rVSV
vectored
vaccine
is
safe
and
well
‐
tolerated
at
all
dose
levels.
Furthermore,
63%
of
vaccinated
volunteers
at
the
highest
dose
level
tested
demonstrated
significant
HIV
gag
‐
specific
CMI
responses.
•
In
HVTN
‐
087
,
a
fixed
priming
dose
of
the
Profectus
HIV
MAg
‐
pDNA
vaccine
with
various
dose
levels
of
GENEVAX™
IL
‐
12
pDNA
adjuvant
delivered
with
the
TriGrid™
device,
followed
by
booster
immunization
with
the
Profectus
rVSV
‐
vectored
HIV
vaccine
delivered
by
intramuscular
injection,
is
being
evaluated
in
HIV
‐
negative
volunteers.
This
placebo
‐
controlled
study
has
fully
enrolled
100/100
subjects
at
6
clinical
sites.
No
dose
‐
limiting
toxicities
have
been
seen,
and
the
immunogenicity
data
are
anticipated
in
early
2014.
About
the
Profectus
Multi
‐
Antigen
Therapeutic
HIV
pDNA
Vaccine
and
GENEVAX™
IL
‐
12
pDNA
adjuvant
The
Profectus
multi
‐
antigen
HIV
pDNA
vaccine
consists
of
two
plasmid
vectors
designed
to
induce
immune
responses
against
the
env
,
gag
,
pol
,
nef
,
tat
,
and
vif
proteins
of
HIV.
GENEVAX™
IL
‐
12
is
a
proprietary
dual
‐
promoter
pDNA
vector
that
expresses
the
immune
modulating
cytokine
human
interleukin
‐
12.
The
pDNA
vectors
are
supplied
for
clinical
use
in
a
proprietary
formulation
containing
the
anesthetic
bupivacaine.
In
addition
to
its
anesthetic
properties,
bupivacaine
has
been
shown
to
enhance
the
efficiency
of
DNA
vaccines
and
to
provide
a
liquid
formulation
with
multi
‐
year
stability.
About
the
rVSV
HIV
‐
1
gag
vaccine
The
rVSV
HIV
‐
1
gag
vaccine
consists
of
an
attenuated
replication
competent
form
of
the
Indiana
serotype
of
rVSV
that
expresses
the
HIV
‐
1
gag
protein.
It
is
designed
to
elicit
a
robust
cell
mediated
immune
response
to
the
HIV
‐
1
gag
protein
when
used
to
boost
following
pDNA
priming,
and
is
being
supplied
in
frozen
formulation
to
this
proof
‐
of
‐
concept
study.
Ongoing
studies
are
examining
the
potential
to
develop
a
lyophilized
formulation
that
will
replace
the
frozen
form,
and
greatly
simplify
distribution
of
vaccine
to
the
developing
world.
About
NIAID
NIAID
conducts
and
supports
research—at
NIH,
throughout
the
United
States,
and
worldwide—to
study
the
causes
of
infectious
and
immune
‐
mediated
diseases,
and
to
develop
better
means
of
preventing,
diagnosing
and
treating
these
illnesses.
News
releases,
fact
sheets
and
other
NIAID
‐
related
materials
are
available
on
the
NIAID
Web
site
at
http://www.niaid.nih.gov/
.
About
Ichor
Medical
Systems
Ichor
is
dedicated
to
the
clinical
application
and
commercialization
of
electroporation
technology
for
the
delivery
of
DNA
drugs
and
vaccines
to
treat
and
prevent
debilitating
or
life
threatening
diseases.
The
company's
proprietary
TriGrid™
Delivery
System
enables
the
efficient
delivery
of
DNA
drugs
to
address
unmet
medical
needs
in
areas
including
therapeutic
cancer
vaccines,
therapeutic
proteins
and
vaccines
for
serious
infectious
disease.
