293 research outputs found
Harmonization study between three laboratories for expression of malaria vaccine clinical trial IgG antibody ELISA data in ”g/mL
Background
The ability to report vaccine-induced IgG responses in terms of ”g/mL, as opposed arbitrary units (AU), enables a more informed interpretation of the magnitude of the immune response, and better comparison between vaccines targeting different antigens. However, these interpretations rely on the accuracy of the methodology, which is used to generate ELISA data in ”g/mL. In a previous clinical trial of a vaccine targeting the apical membrane antigen 1 (AMA1) from Plasmodium falciparum, three laboratories (Oxford, NIH and WRAIR) reported ELISA data in ”g/mL that were correlated but not concordant. This current study sought to harmonize the methodology used to generate a conversion factor (CF) for ELISA analysis of human anti-AMA1 IgG responses across the three laboratories.
Methods
Purified IgG was distributed to the three laboratories and, following a set protocol provided by NIH, AMA1-specific human IgG was affinity purified. A new âharmonized CFâ was generated by each laboratory using their in-house ELISA, and the original clinical trial ELISA data were re-analysed accordingly.
Results
Statistical analysis showed that the data remained highly correlated across all three laboratories, although only Oxford and NIH were able to harmonize their CF for ELISA and generate concordant data.
Conclusions
This study enabled two out of the three laboratories to harmonize their ”g/mL readouts for the human anti-AMA1 IgG ELISA, but results reported from WRAIR areâ~âtwofold higher. Given the need to validate such information for each species and antigen of interest, it is important to bear in mind these likely differences when interpreting ”g/mL ELISA data in the future
Harmonization study between three laboratories for expression of malaria vaccine clinical trial IgG antibody ELISA data in ”g/mL
Background
The ability to report vaccine-induced IgG responses in terms of ”g/mL, as opposed arbitrary units (AU), enables a more informed interpretation of the magnitude of the immune response, and better comparison between vaccines targeting different antigens. However, these interpretations rely on the accuracy of the methodology, which is used to generate ELISA data in ”g/mL. In a previous clinical trial of a vaccine targeting the apical membrane antigen 1 (AMA1) from Plasmodium falciparum, three laboratories (Oxford, NIH and WRAIR) reported ELISA data in ”g/mL that were correlated but not concordant. This current study sought to harmonize the methodology used to generate a conversion factor (CF) for ELISA analysis of human anti-AMA1 IgG responses across the three laboratories.
Methods
Purified IgG was distributed to the three laboratories and, following a set protocol provided by NIH, AMA1-specific human IgG was affinity purified. A new âharmonized CFâ was generated by each laboratory using their in-house ELISA, and the original clinical trial ELISA data were re-analysed accordingly.
Results
Statistical analysis showed that the data remained highly correlated across all three laboratories, although only Oxford and NIH were able to harmonize their CF for ELISA and generate concordant data.
Conclusions
This study enabled two out of the three laboratories to harmonize their ”g/mL readouts for the human anti-AMA1 IgG ELISA, but results reported from WRAIR areâ~âtwofold higher. Given the need to validate such information for each species and antigen of interest, it is important to bear in mind these likely differences when interpreting ”g/mL ELISA data in the future
Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration
While new vaccines for SARS-CoV-2 are authorized based on neutralizing antibody (nAb) titer against emerging variants of concern, an analogous pathway does not exist for preventative monoclonal antibodies. In this work, nAb titers were assessed as correlates of protection against COVID-19 in the casirivimab + imdevimab monoclonal antibody (mAb) prevention trial (ClinicalTrials.gov #NCT4452318) and in the mRNA-1273 vaccine trial (ClinicalTrials.gov #NCT04470427). In the mAb trial, protective efficacy of 92% (95% confidence interval (CI): 84%, 98%) is associated with a nAb titer of 1000 IU50/ml, with lower efficacy at lower nAb titers. In the vaccine trial, protective efficacies of 93% [95% CI: 91%, 95%] and 97% (95% CI: 95%, 98%) are associated with nAb titers of 100 and 1000 IU50/ml, respectively. These data quantitate a nAb titer correlate of protection for mAbs benchmarked alongside vaccine induced nAb titers and support nAb titer as a surrogate endpoint for authorizing new mAbs
Measurement of W Polarisation at LEP
The three different helicity states of W bosons produced in the reaction e+
e- -> W+ W- -> l nu q q~ at LEP are studied using leptonic and hadronic W
decays. Data at centre-of-mass energies \sqrt s = 183-209 GeV are used to
measure the polarisation of W bosons, and its dependence on the W boson
production angle. The fraction of longitudinally polarised W bosons is measured
to be 0.218 \pm 0.027 \pm 0.016 where the first uncertainty is statistical and
the second systematic, in agreement with the Standard Model expectation
Measurement of W Polarisation at LEP
The three different helicity states of W bosons produced in the reaction e+
e- -> W+ W- -> l nu q q~ at LEP are studied using leptonic and hadronic W
decays. Data at centre-of-mass energies \sqrt s = 183-209 GeV are used to
measure the polarisation of W bosons, and its dependence on the W boson
production angle. The fraction of longitudinally polarised W bosons is measured
to be 0.218 \pm 0.027 \pm 0.016 where the first uncertainty is statistical and
the second systematic, in agreement with the Standard Model expectation
Bose-Einstein Correlations of Neutral and Charged Pions in Hadronic Z Decays
Bose-Einstein correlations of both neutral and like-sign charged pion pairs
are measured in a sample of 2 million hadronic Z decays collected with the L3
detector at LEP. The analysis is performed in the four-momentum difference
range 300 MeV < Q < 2 GeV. The radius of the neutral pion source is found to be
smaller than that of charged pions. This result is in qualitative agreement
with the string fragmentation model
Measurement of the W+W-gamma Cross Section and Direct Limits on Anomalous Quartic Gauge Boson Couplings at LEP
The process e+e- -> W+W-gamma is analysed using the data collected with the
L3 detector at LEP at a centre-of-mass energy of 188.6GeV, corresponding to an
integrated luminosity of 176.8pb^-1. Based on a sample of 42 selected W+W-
candidates containing an isolated hard photon, the W+W-gamma cross section,
defined within phase-space cuts, is measured to be: sigma_WWgamma = 290 +/- 80
+/- 16 fb, consistent with the Standard Model expectation. Including the
process e+e- -> nu nu gamma gamma, limits are derived on anomalous
contributions to the Standard Model quartic vertices W+W- gamma gamma and W+W-Z
gamma at 95% CL: -0.043 GeV^-2 < a_0/Lambda^2 < 0.043 GeV^-2 0.08 GeV^-2 <
a_c/Lambda^2 < 0.13 GeV^-2 0.41 GeV^-2 < a_n/Lambda^2 < 0.37 GeV^-2
Production of Single W Bosons at \sqrt{s}=189 GeV and Measurement of WWgamma Gauge Couplings
Single W boson production in electron-positron collisions is studied with the
L3 detector at LEP. The data sample collected at a centre-of-mass energy of
\sqrt{s} = 188.7GeV corresponds to an integrated luminosity of 176.4pb^-1.
Events with a single energetic lepton or two acoplanar hadronic jets are
selected. Within phase-space cuts, the total cross-section is measured to be
0.53 +/- 0.12 +/- 0.03 pb, consistent with the Standard Model expectation.
Including our single W boson results obtained at lower \sqrt{s}, the WWgamma
gauge couplings kappa_gamma and lambda_gamma are determined to be kappa_gamma =
0.93 +/- 0.16 +/- 0.09 and lambda_gamma = -0.31 +0.68 -0.19 +/- 0.13
Lambda and Sigma0 Pair Production in Two-Photon Collisions at LEP
Strange baryon pair production in two-photon collisions is studied with the
L3 detector at LEP. The analysis is based on data collected at e+e-
centre-of-mass energies from 91 GeV to 208 GeV, corresponding to an integrated
luminosity of 844 pb-1. The processes gamma gamma -> Lambda Anti-lambda and
gamma gamma -> Sigma0 Anti-sigma0 are identified. Their cross sections as a
function of the gamma gamma centre-of-mass energy are measured and results are
compared to predictions of the quark-diquark model
Study of the e+e- -> Ze+e- process at LEP
The cross section of the process e+e- -> Ze+e is measured with 0.7fb^-1 of
data collected with the L3 detector at LEP. Decays of the Z boson into quarks
and muons are considered at centre-of-mass energies ranging from 183GeV up to
209GeV. The measurements are found to agree with Standard Model predictions,
achieving a precision of about 10% for the hadronic channel
- âŠ