Statistical considerations for vaccine immunogenicity trials

Plikaytis, Brian D.; Carlone, George M.

doi:10.1016/j.vaccine.2004.06.046

Cited by 14 publications

(2 citation statements)

References 27 publications

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“…Each serum SRS and the urine SRS are serially diluted on each microtiter plate in two-fold steps using a dilution buffer (5% Bovine Serum Albumin in PBS and 0.5% Tween-20 at a pH of 7.2). The ODs of each dilution point are then used to generate the SCC by 4-PL regression modeling (SOFTmax PRO version 5.4 software) [23], [24]. To generate the SCC, Arbitrary Units (AU) of antibody are assigned to the Standard Calibration Curves as shown in Table S1.…”

Section: Methodsmentioning

confidence: 99%

Microproteinuria during Opisthorchis viverrini Infection: A Biomarker for Advanced Renal and Hepatobiliary Pathologies from Chronic Opisthorchiasis

et al. 2013

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Approximately 680 million people are at risk of infection with Opisthorchis viverrini (OV) and Clonorchis sinensis, with an estimated 10 million infected with OV in Southeast Asia alone. While opisthorchiasis is associated with hepatobiliary pathologies, such as advanced periductal fibrosis (APF) and cholangiocarcinoma (CCA), animal models of OV infection show that immune-complex glomerulonephritis is an important renal pathology that develops simultaneously with hepatobiliary pathologies. A cardinal sign of immune-complex glomerulonephritis is the urinary excretion of immunoglobulin G (IgG) (microproteinuria). In community-based studies in OV endemic areas along the Chi River in northeastern Thailand, we observed that over half of the participants had urine IgG against a crude OV antigen extract (OV antigen). We also observed that elevated levels of urine IgG to OV antigen were not associated with the intensity of OV infection, but were likely the result of immune-complex glomerulonephritis as seen in animal models of OV infection. Moreover, we observed that urine IgG to OV antigen was excreted at concentrations 21 times higher in individuals with APF and 158 times higher in individuals with CCA than controls. We also observed that elevated urine IgG to OV antigen could identify APF+ and CCA+ individuals from non-cases. Finally, individuals with urine IgG to OV antigen had a greater risk of APF as determined by Odds Ratios (OR = 6.69; 95%CI: 2.87, 15.58) and a greater risk of CCA (OR = 71.13; 95%CI: 15.13, 334.0) than individuals with no detectable level of urine IgG to OV antigen. Herein, we show for the first time the extensive burden of renal pathology in OV endemic areas and that a urine biomarker could serve to estimate risk for both renal and hepatobiliary pathologies during OV infection, i.e., serve as a “syndromic biomarker” of the advanced pathologies from opisthorchiasis.

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Section: Methodsmentioning

confidence: 99%

Microproteinuria during Opisthorchis viverrini Infection: A Biomarker for Advanced Renal and Hepatobiliary Pathologies from Chronic Opisthorchiasis

et al. 2013

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“…Each serum SRS and the urine SRS are serially diluted on each microtiter plate in two-fold steps using a dilution buffer (5% Bovine Serum Albumin in PBS and 0.5% Tween-20 at a pH of 7.2). The ODs of each dilution point are then used to generate the SCC by 4-PL regression modeling (SOFTmax PRO version 5.4 software) [23,24]. To generate the SCC, Arbitrary Units (AU) of antibody are assigned to the Standard Calibration Curves as shown in Table S1.…”

Section: Development Of a Qualified Indirect Enzyme-linked Immunosorb...mentioning

confidence: 99%

Correction: Microproteinuria during Opisthorchis viverrini Infection: A Biomarker for Advanced Renal and Hepatobiliary Pathologies from Chronic Opisthorchiasis

Saichua¹,

Sithithaworn²,

Jariwala³

et al. 2013

PLoS Negl Trop Dis

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Approximately 680 million people are at risk of infection with Opisthorchis viverrini (OV) and Clonorchis sinensis, with an estimated 10 million infected with OV in Southeast Asia alone. While opisthorchiasis is associated with hepatobiliary pathologies, such as advanced periductal fibrosis (APF) and cholangiocarcinoma (CCA), animal models of OV infection show that immune-complex glomerulonephritis is an important renal pathology that develops simultaneously with hepatobiliary pathologies. A cardinal sign of immune-complex glomerulonephritis is the urinary excretion of immunoglobulin G (IgG) (microproteinuria). In community-based studies in OV endemic areas along the Chi River in northeastern Thailand, we observed that over half of the participants had urine IgG against a crude OV antigen extract (OV antigen). We also observed that elevated levels of urine IgG to OV antigen were not associated with the intensity of OV infection, but were likely the result of immune-complex glomerulonephritis as seen in animal models of OV infection. Moreover, we observed that urine IgG to OV antigen was excreted at concentrations 21 times higher in individuals with APF and 158 times higher in individuals with CCA than controls. We also observed that elevated urine IgG to OV antigen could identify APF+ and CCA+ individuals from non-cases. Finally, individuals with urine IgG to OV antigen had a greater risk of APF as determined by Odds Ratios (OR = 6.69; 95%CI: 2.87, 15.58) and a greater risk of CCA (OR = 71.13; 95%CI: 15.13, 334.0) than individuals with no detectable level of urine IgG to OV antigen. Herein, we show for the first time the extensive burden of renal pathology in OV endemic areas and that a urine biomarker could serve to estimate risk for both renal and hepatobiliary pathologies during OV infection, i.e., serve as a ''syndromic biomarker'' of the advanced pathologies from opisthorchiasis.

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Functional Antibody Assays

Feavers

Walker

2009

Methods in Molecular Biology

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Functional antibody assays can broadly be divided into three categories: neutralisation, serum bactericidal antibody (SBA) and opsonophagocytic assays (OPA). These biological assays are generally more complex than antibody-binding counterparts. They invariably involve multiple biological components, many of which are difficult or impossible to standardise. The aim of this chapter is to provide working examples of these assays and highlight the key issues to be addressed to ensure they are able to provide reliable data.

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Statistical considerations for vaccine immunogenicity trials

Cited by 14 publications

References 27 publications

Microproteinuria during Opisthorchis viverrini Infection: A Biomarker for Advanced Renal and Hepatobiliary Pathologies from Chronic Opisthorchiasis

Microproteinuria during Opisthorchis viverrini Infection: A Biomarker for Advanced Renal and Hepatobiliary Pathologies from Chronic Opisthorchiasis

Correction: Microproteinuria during Opisthorchis viverrini Infection: A Biomarker for Advanced Renal and Hepatobiliary Pathologies from Chronic Opisthorchiasis

Functional Antibody Assays

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