scholarly journals Modelling the concentration of anti-SARS-CoV-2 immunoglobulin G in intravenous immunoglobulin product batches

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259731
Author(s):  
Sara Stinca ◽  
Thomas W. Barnes ◽  
Peter Vogel ◽  
Wilfried Meyers ◽  
Johannes Schulte-Pelkum ◽  
...  

Background Plasma-derived intravenous immunoglobulin (IVIg) products contain a dynamic spectrum of immunoglobulin (Ig) G reactivities reflective of the donor population from which they are derived. We sought to model the concentration of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG which could be expected in future plasma pool and final-product batches of CSL Behring’s immunoglobulin product Privigen. Study design and methods Data was extracted from accessible databases, including the incidence of coronavirus disease 2019 and SARS-CoV-2 vaccination status, antibody titre in convalescent and vaccinated groups and antibody half-life. Together, these parameters were used to create an integrated mathematical model that could be used to predict anti-SARS-CoV-2 antibody levels in future IVIg preparations. Results We predict that anti-SARS-CoV-2 IgG concentration will peak in batches produced in mid-October 2021, containing levels in the vicinity of 190-fold that of the mean convalescent (unvaccinated) plasma concentration. An elevated concentration (approximately 35-fold convalescent plasma) is anticipated to be retained in batches produced well into 2022. Measurement of several Privigen batches using the Phadia™ EliA™ SARS-CoV-2-Sp1 IgG binding assay confirmed the early phase of this model. Conclusion The work presented in this paper may have important implications for physicians and patients who use Privigen for indicated diseases.

2021 ◽  
Vol 9 ◽  
Author(s):  
Hamad Ali ◽  
Barrak Alahmad ◽  
Abdullah A. Al-Shammari ◽  
Abdulmohsen Alterki ◽  
Maha Hammad ◽  
...  

Background: The emergence of new COVID-19 variants of concern coupled with a global inequity in vaccine access and distribution has prompted many public health authorities to circumvent the vaccine shortages by altering vaccination protocols and prioritizing persons at high risk. Individuals with previous COVID-19 infection may not have been prioritized due to existing humoral immunity.Objective: We aimed to study the association between previous COVID-19 infection and antibody levels after COVID-19 vaccination.Methods: A serological analysis to measure SARS-CoV-2 immunoglobulin (Ig)G, IgA, and neutralizing antibodies was performed on individuals who received one or two doses of either BNT162b2 or ChAdOx1 vaccines in Kuwait. A Student t-test was performed and followed by generalized linear regression models adjusted for individual characteristics and comorbidities were fitted to compare the average levels of IgG and neutralizing antibodies between vaccinated individuals with and without previous COVID-19 infection.Results: A total of 1,025 individuals were recruited. The mean levels of IgG, IgA, and neutralizing antibodies were higher in vaccinated subjects with previous COVID-19 infections than in those without previous infection. Regression analysis showed a steeper slope of decline for IgG and neutralizing antibodies in vaccinated individuals without previous COVID-19 infection compared to those with previous COVID-19 infection.Conclusion: Previous COVID-19 infection appeared to elicit robust and sustained levels of SARS-CoV-2 antibodies in vaccinated individuals. Given the inconsistent supply of COVID-19 vaccines in many countries due to inequities in global distribution, our results suggest that even greater efforts should be made to vaccinate more people, especially individuals without previous COVID-19 infection.


Author(s):  
Joshua G Petrie ◽  
Latifa A Bazzi ◽  
Adrian B McDermott ◽  
Dean Follmann ◽  
Dominic Esposito ◽  
...  

Abstract Background We investigated frequency of reinfection with seasonal coronaviruses (HCoV) and serum antibody response following infection over 8 years in the Household Influenza Vaccine Evaluation cohort. Methods Households were followed annually for identification of acute respiratory illness with RT-PCR confirmed HCoV infection. Serum collected before and at two time points post infection were tested using a multiplex binding assay to quantify antibody to seasonal, SARS-CoV-1, and SARS-CoV-2 spike proteins and SARS-CoV-2 spike sub-domains and N protein. Results Of 3418 participants, 40% were followed for ≥3years. A total of 1004 HCoV infections were documented; 303 (30%) were reinfections of any HCoV type. The number of HCoV infections ranged from 1 to 13 per individual. The mean time to reinfection with the same type was estimated at 983 days for 229E, 578 days for HKU1, 615 days for OC43, and 711 days for NL63. Binding antibody levels to seasonal HCoVs were high, with little increase post-infection, and were maintained over time. Homologous, pre-infection antibody levels did not significantly correlate with odds of infection, and there was little cross response to SARS-CoV-2 proteins. Conclusions Reinfection with seasonal HCoVs is frequent. Binding anti-spike protein antibodies do not correlate with protection from seasonal HCoV infection.


Author(s):  
Shivananda B Nayak ◽  
Dharindra Sawh ◽  
Brandon Scott ◽  
Vestra Sears ◽  
Kareshma Seebalack ◽  
...  

Purpose: i) To determine the relationship between the cardiac biomarkers ST2 and NT-proBNP with ejection fraction (EF) in heart failure (HF) patients. ii) Assess whether a superiority existed between the aforementioned cardiac markers in diagnosing the HF with reduced EF. iii) Determine the efficacy of both biomarkers in predicting a 30-day cardiovascular event and rehospitalization in patients with HF with reduced EF iv) To assess the influence of age, gender, BMI, anaemia and renal failure on the ST2 and NT-proBNP levels. Design and Methods: A prospective double-blind study was conducted to obtain data from a sample of 64 cardiology patients. A blood sample was collected to test for ST2 and NT-proBNP. An echocardiogram (to obtain EF value), electrocardiogram and questionnaire were also obtained. Results: Of the 64 patients enrolled, 59.4% of the population had an EF less than 40%. At the end of the 30- day period, 7 patients were warded, 37 were not warded, one died and 17 were non respondent. Both biomarkers were efficacious at diagnosing HF with a reduced EF. However, neither of them were efficacious in predicting 30-day rehospitalization. The mean NT-proBNP values being: not rehospitalized (2114.7486) and 30 day rehospitalization (1008.42860) and the mean ST2 values being: not rehospitalized (336.1975), and 30-day rehospitalization. (281.9657). Conclusion: Neither ST2 or NT-proBNP was efficacious in predicting the short- term prognosis in HF with reduced EF. Both however were successful at confirming the diagnosis of HF in HF patients with reduced EF.


2014 ◽  
Vol 9 (4) ◽  
pp. 30-35
Author(s):  
S Datta ◽  
S Maiti ◽  
G Das ◽  
A Chatterjee ◽  
P Ghosh

Background The diagnosis of classical Kawasaki Disease was based on clinical criteria. The conventional criteria is particularly useful in preventing over diagnosis, but at the same time it may result in failure to recognize the incomplete form of Kawasaki Disease. Objective To suspect incomplete Kawasaki Disease, because early diagnosis and proper treatment may reduce substantial risk of developing coronary artery abnormality which is one of the leading causes of acquired heart disease in children. Method Nine cases of incomplete Kawasaki Disease were diagnosed over a period of one year. The diagnosis of incomplete Kawasaki Disease was based on fever for five days with less than four classical clinical features and cardiac abnormality detected by 2D- echocardiography. A repeat echocardiography was done after 6 weeks of onset of illness. The patients were treated with Intravenous Immunoglobulin and/or aspirin. Result The mean age of the patients was 3.83 years and the mean duration of symptoms before diagnosis was 12.1 days. Apart from other criteria all of our patients had edema and extreme irritability. All the patients had abnormal echocardiographic finding. Five patients received only aspirin due to nonaffordability of Intravenous Immunoglobulin and four patients received both aspirin and Intravenous Immunoglobulin, but the outcome was excellent in all the cases. Conclusion Incomplete Kawasaki Disease can be diagnosed with more awareness and aspirin alone may be used as a second line therapy in case of non affordability of Intravenous Immunoglobulin. Journal of College of Medical Sciences-Nepal, 2013, Vol-9, No-4, 30-35 DOI: http://dx.doi.org/10.3126/jcmsn.v9i4.10234


1988 ◽  
Vol 101 (2) ◽  
pp. 405-410 ◽  
Author(s):  
R. C. H Lau

SUMMARYEnzyme-linked immunosorbent assay (ELISA) tests were used to measure IgG antibody levels in 2638 New Zealand children who had been immunized with the triple vaccine DTP. The percentage of children immune to diphtheria decreased with age. The percentage of children immune to tetanus varied from 67.1 to 55.0%. The percentage of children with measurable antibody to pertussis increased with age. The mean percentages of children with measurable antibody or immunity to one or more DTP components were 34.2% (with 3 components), 34.4% (2 components), and 78.1% (1 component). It appears the immunization strategy for diphtheria and tetanus is satisfactory for herd immunity in New Zealand children. However, the current pertussis strategy may not be providing adequate immunity to 5-year-olds in this country.


2000 ◽  
Vol 15 (1) ◽  
pp. 62-69 ◽  
Author(s):  
C.G.J. Sweep ◽  
J. Geurts-Moespot

Steroid receptor assays have clinical relevance in selecting women who would benefit from endocrine intervention. As the degree of benefit from endocrine therapy is directly related to the quantity of receptor present in the tumour, the quality of the steroid receptor assays is important. Moreover, since patients entered in multi-centre trials often include stratification based on the receptor status, receptor assays should be comparable between different institutes. ER- and PgR-assays have been evaluated in quality assessment studies for almost 20 years by the EORTC Receptor and Biomarker Study Group. During the QA trial 1998/1999 results were reported by 42 participants performing the Ligand Binding Assay (LBA) and by 39 participants using the Enzyme Immuno-Assay (EIA) kit. Each participant received a set of 12 QA vials to be analysed two at a time at two-monthly intervals. The between-laboratory CVs of ER LBA and EIA amounted to 40–50%. For PgR the between-lab CVs for the EIA method are lower as compared with LBA but still are approx. 30%. Notwithstanding the high deviation in reported values and the high between-lab CVs, the consistency of the participants over the year is acceptable, which pave the way for calibration. Indeed, after normalization of assay results the mean between-lab CVs dropped to 11% for ER LBA, 14% for ER EIA, 9% for PgR LBA and 11% for PgR EIA. Such a reduction of between-laboratory CVs is an essential requirement for the use of steroid receptor data in multicentre clinical studies.


2011 ◽  
Vol 25 (1) ◽  
pp. 13
Author(s):  
Nisarath Soontrapa ◽  
Sukree Soontrapa ◽  
Srinaree Kaewrudee ◽  
Woraluk Somboonporn ◽  
Chuanchom Sakondhavat

<em>Objectives</em>. To determine the prevalence of urogenital symptoms (vaginal dryness, dyspareunia, urinary incontinence) and assess patient’s consultation rate and desire for treatment. <em>Design and Methods.</em> This study was prospective descriptive study, performed with the participation of 125 women who presented in menopausal clinic, Srinagarind Hospital. Women completed the questionnaire including questions about their demographic properties and were interviewed by pre-validated questionnaire and in-depth interview to determine the prevalence of urogenital symptoms, consultation rate and patient’s desire for treatment. <em>Results</em>. The mean age of the participants was 57.1 years. Vaginal dryness was found to be the most common postmenopausal urogenital symptoms (71.2%), followed by urinary incontinence (62.4%) and dyspareunia (52.0%). The consultation rates were 62.2% in vaginal dryness, 46.2% in dyspareunia and 38.5% in urinary incontinence. Patient’s desire for treatment was 66.7% in vaginal dryness, 62.1% in dyspareunia and 53.8% in urinary incontinence. <em>Conclusions</em>. Urogenital symptoms are highly prevalent. Physicians need to improve patient-physician communication and increase their attention to these symptoms and their patient’s attitudes to improve patient’s quality of life.


2019 ◽  
Vol 5 (2) ◽  
pp. 118-122
Author(s):  
Uzzwal Kumar Mallick ◽  
Mohammad Shah Jahirul Hoque Chowdhury ◽  
Mohammad Enayet Hussain ◽  
Mohammad Asaduzzaman ◽  
Md Sirajul Islam ◽  
...  

Background: The management of Guillain-Barré Syndrome is very crucial for the outcome of the patient. Objective: The aim of the study was to compare efficacy of IvIg(Intravenous Immunoglobulin) versus PE(Plasmaexchange) in treatment of mechanically ventilation adults with GBS in neuro-intensive care unit of Bangladesh. Methodology: Thiswas a prospective, observationalcohort study, in a Neuro-ICU from 2017 to 2018. We included all patients with GBS who required mechanical ventilation (MV). We defined two groups: group 1 (group treated by IvIg: 0.4 g/kg/day for 5 days) and group 2 (group treated by PE: 5 PE during 10days, every alternate day). We collectedclinical and therapeutic aspects and outcome. Results: A total number of 49 patients (34 in group 1 and 15 in group 2) were enrolled. The mean age was 37.4±9.2 years, with a male predominance (65.3%). on electrophysiological findings, in 4(32.7%) patients had acute inflammatory demyelinating polyradiculoneuropathy (AIDP) and acute motor axonal neuropathy (AMAN) in 26 (53.1%) patients and acute motor-sensory axonal neuropathy (AMSAN) was 3(6.1%)and NCS was not done in 4(8.2%) cases. The mean length of ICU stay was 20±19.10 days and 46.60±30.02 days in IVIG and PE group respectively. The ICU stay was significantly shorter (p = 0.001) in the IvIg group than PE group. Patients receiving IvIg were early weaned of MV (p = 0.002) compared to those receiving PE with a statistical significance. Also, duration of M/V (P=.002), Need of tracheostomy (p=.005) and over all surval rate (p=.007) was significantly in favoue of IvIg group than PE group. Out of 49 patients, total 3 patients were died and they all were AMAN variety. Conclusion: Our work reveals a meaningful difference for the MV duration, ICU stay, weaning and excellent recovery in IvIg group compared to PE group in terms of less complcations. Journal of National Institute of Neurosciences Bangladesh, 2019;5(2): 118-122


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