Antiviral activity of an ACE2-Fc fusion protein against SARS-CoV-2 and its variants
PLoS ONE,
Год журнала:
2025,
Номер
20(1), С. e0312402 - e0312402
Опубликована: Янв. 3, 2025
SARS-CoV-2
has
continued
spreading
around
the
world
in
recent
years
since
initial
outbreak
2019,
frequently
developing
into
new
variants
with
greater
human
infectious
capacity.
and
its
mutants
use
angiotensin-converting
enzyme
2
(ACE2)
as
a
cellular
entry
receptor,
which
triggered
several
therapeutic
strategies
against
COVID-19
relying
on
of
ACE2
recombinant
proteins
decoy
receptors.
In
this
work,
we
propose
an
silent
Fc
fusion
protein
(ACE2-hFcLALA)
candidate
therapy
COVID-19.
This
was
able
to
block
binding
RBD
receptor
measured
by
ELISA
flow
cytometry
inhibition
assays.
Moreover,
used
classical
neutralization
assays
progeny
assay
show
that
ACE2-hFcLALA
is
capable
neutralizing
authentic
virus.
Additionally,
found
more
effective
preventing
vitro
infection
different
interest
(
alpha
,
beta
delta
omicron
)
compared
D614G
strain.
Our
results
suggest
potential
molecule
be
both
preventive
settings
current
emerging
gateway
cells.
Язык: Английский
Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: primary day-28 analysis of a phase 2/3 open-label study
medRxiv (Cold Spring Harbor Laboratory),
Год журнала:
2024,
Номер
unknown
Опубликована: Ноя. 1, 2024
Summary
Background
Most
of
the
population
has
been
infected
with
SARS-CoV-2
and,
thus,
is
primed
by
natural
exposure.
As
such,
it
was
assessed
whether
a
single
dose
monovalent
XBB.1.5
vaccine,
NVX-CoV2601,
elicited
comparable
immune
response
to
in
seropositive
unvaccinated
participants
that
previously
vaccinated
participants,
thereby
allowing
former
forego
two-dose
primary
series.
Methods
In
this
phase
2/3,
open-label,
single-arm
study
(2019nCoV-313/
NCT05975060
[part
2]),
vaccine-naive
≥18
years
previous
infection
received
one
NVX-CoV2601.
This
analysis
compared
28-day
immunogenicity
and
safety
NVX-CoV2601
(≥3
prior
mRNA-based
vaccines,
from
2019nCoV-313
part
1)
participants.
Noninferiority
neutralizing
antibody
(nAb)
versus
objective.
The
day-28
geometric
mean
titer
(GMT)
ratio
(GMTR)
seroresponse
rate
(SRR;
percentage
≥4-fold
rise
baseline)
were
measured,
assessed.
Results
Of
enrolled
September
11–November
15,
2023,
per-protocol
sets
included
306/338
(90.5%)
309/332
(93.1%)
At
day
28,
adjusted
GMTs
(95%
CI)
against
groups
1491.5
(1277.5–1741.4)
841.4
(723.9–978.0),
respectively.
vaccine-naïve—vaccinated
nAb
GMTR
1.8
CI
1.43–2.20)
SRRs
74.3%
64.3%
for
respectively
(SRR
difference:
10.0
[95%
2.6–17.4]).
No
new
signals
or
events
special
interest
reported.
Conclusions
A
history
robust
noninferior
observed
vaccine
well-tolerated.
These
data
support
use
as
dose,
regardless
vaccination
history.
Trial
registration:
Язык: Английский
Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study
Vaccine,
Год журнала:
2025,
Номер
55, С. 127046 - 127046
Опубликована: Апрель 4, 2025
Язык: Английский
Validation of a Pseudovirus Neutralization Assay for Severe Acute Respiratory Syndrome Coronavirus 2: A High-Throughput Method for the Evaluation of Vaccine Immunogenicity
Microorganisms,
Год журнала:
2024,
Номер
12(6), С. 1201 - 1201
Опубликована: Июнь 14, 2024
The
evaluation
of
coronavirus
disease
2019
(COVID-19)
vaccine
immunogenicity
remains
essential
as
the
severe
acute
respiratory
syncytial
virus
2
(SARS-CoV-2)
pandemic
continues
to
evolve
and
additional
variants
emerge.
Neutralizing
antibodies
are
a
known
correlate
protection
for
SARS-CoV-2
vaccines.
A
pseudovirus
neutralization
(PNT)
assay
was
developed
validated
at
Novavax
Clinical
Immunology
Laboratories
allow
detection
neutralizing
in
clinical
trial
sera.
PNT
precise,
accurate,
linear,
specific
measuring
titers
human
serum
ancestral
strain
Omicron
subvariants
BA.5
XBB.1.5,
with
an
overall
geometric
coefficient
variation
≤43.4%,
percent
relative
bias
within
expected
range
−60%
150%,
linearity
value
R2
>
0.98
all
three
strains.
This
will
be
useful
analysis
samples
assess
immunogenicity.
Future
work
focus
on
modifying
emerging
variants,
including
XBB.1.16,
EG.5.1,
BA.2.86,
any
other
that
emerge
ongoing
pandemic.
Язык: Английский
Nanoparticle-Supported, Rapid, Digital Quantification of Neutralizing Antibodies Against SARS-CoV-2 Variants
bioRxiv (Cold Spring Harbor Laboratory),
Год журнала:
2024,
Номер
unknown
Опубликована: Ноя. 6, 2024
Abstract
The
measurement
of
neutralizing
immune
responses
to
viral
infection
is
essential,
given
the
heterogeneity
human
immunity
and
emergence
new
virus
strains.
However,
antibody
(nAb)
assays
often
require
high-level
biosafety
containment,
sophisticated
instrumentation,
long
detection
times.
Here,
as
a
proof-of-principle,
we
designed
nanoparticle-supported,
rapid,
electronic
(NasRED)
assay
assess
potency
monoclonal
antibodies
(mAbs)
against
SARS-CoV-2.
gold
nanoparticles
(AuNPs)
coated
with
angiotensin-converting
enzyme
2
(ACE2)
protein
nAb
reporters
were
mixed
mAbs
be
tested,
well
streptavidin-conjugated
multivalent
spike
(S)
or
their
receptor
binding
domains
(RBD).
High-affinity
ACE2-competitive
nAbs
alter
S
(or
RBD)-to-ACE2
level
modulate
AuNP
cluster
formation
precipitation.
amount
free-floating
quantified
by
semiconductor-based
readout
system
that
measures
AuNPs’
optical
extinction,
producing
signals
can
differentiate
SARS-CoV-2
variants
(Wuhan-Hu-1,
Gamma,
Omicron).
modular
design
nature,
short
time
(less
than
30
minutes),
portable
inexpensive
make
this
NasRED-nAb
applicable
measuring
vaccine
potency,
infection,
efficacy
antibody-based
therapies.
Язык: Английский