| 1. |
- Asplund, M, et al.
(författare)
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Toxicity evaluation of PEDOT/biomolecular composites intended for neural communication electrodes
- 2009
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Ingår i: BIOMEDICAL MATERIALS. - : IOP Publishing. - 1748-6041 .- 1748-605X. ; 4:4, s. 045009-
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Tidskriftsartikel (refereegranskat)abstract
- Electrodes coated with the conducting polymer poly(3,4-ethylene dioxythiophene) (PEDOT) possess attractive electrochemical properties for stimulation or recording in the nervous system. Biomolecules, added as counter ions in electropolymerization, could further improve the biomaterial properties, eliminating the need for surfactant counter ions in the process. Such PEDOT/biomolecular composites, using heparin or hyaluronic acid, have previously been investigated electrochemically. In the present study, their biocompatibility is evaluated. An agarose overlay assay using L929 fibroblasts, and elution and direct contact tests on human neuroblastoma SH-SY5Y cells are applied to investigate cytotoxicity in vitro. PEDOT: heparin was further evaluated in vivo through polymer-coated implants in rodent cortex. No cytotoxic response was seen to any of the PEDOT materials tested. The examination of cortical tissue exposed to polymer-coated implants showed extensive glial scarring irrespective of implant material (Pt:polymer or Pt). However, quantification of immunological response, through distance measurements from implant site to closest neuron and counting of ED1+ cell density around implant, was comparable to those of platinum controls. These results indicate that PEDOT: heparin surfaces were non-cytotoxic and show no marked difference in immunological response in cortical tissue compared to pure platinum controls.
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| 2. |
- Chowdhury, F., et al.
(författare)
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A phase I/II study to evaluate safety, tolerability and immunogenicity of Hillchol®, an inactivated single Hikojima strain based oral cholera vaccine, in a sequentially age descending population in Bangladesh
- 2021
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Ingår i: Vaccine. - : Elsevier BV. - 0264-410X. ; 39:32, s. 4450-4457
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Tidskriftsartikel (refereegranskat)abstract
- Background: The World Health Organization (WHO) recommends the use of oral cholera vaccines (OCVs) as part of an integrated control program, both in highly endemic settings and during cholera epidemics. The available and internationally recommended WHO-prequalified OCVs (Dukoral, Shanchol, Euvichol) contain multiple heat and formalin-killed V. cholerae strains of Inaba and Ogawa serotypes. MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. in technical collaboration with University of Gothenburg, Sweden has developed a new single strain OCV, Hillchol. This vaccine consists of formaldehyde-inactivated whole cell El Tor V. cholerae O1 bacteria engineered into the Hikojima serotype for stable expression of both the Ogawa (AB) and Inaba (AC) LPS antigens on the bacterial surface. We evaluated the safety and immunogenicity of this novel and potentially much less expensive OCV in comparison with Shanchol. Methods: We conducted a randomized, non-inferiority, age-descending clinical trial of OCV (Hillchol vs. Shanchol) in the Mirpur area of Dhaka city from July 2016 to May 2017. This study was carried out in three different age cohorts (1–<5, 5–17 and ≥18 years old). Two doses of vaccine were given at 14 days intervals to 560 healthy participants. Findings: No serious adverse events were reported. There were no significant differences in the rates of adverse events between the test vaccine (Hillchol) and the comparator (Shanchol) group. Serum vibriocidal antibody responses in all age groups combined were comparable for all the O1 Ogawa (59% vs. 67%; 90% CI of difference: −14.55, −0.84) and Inaba (70% vs. 71%; 90% CI of difference: −7.24, 5.77) serotypes, showing that the Hillchol vaccine was non-inferior to Shanchol. This new vaccine was also non-inferior to Shanchol in the different age strata. Conclusion: The safety and immunogenicity profile of the new OCV Hillchol is comparable to Shanchol in persons residing in a cholera-endemic setting. ClinicalTrials.gov number: NCT02823899. © 2021
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| 3. |
- Criaco, G., et al.
(författare)
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Is blood always thicker than water? : Family firm parents, kinship ties, and the survival of spawns
- 2021
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Ingår i: Journal of Business Venturing. - : Elsevier. - 0883-9026 .- 1873-2003. ; 36:6
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Tidskriftsartikel (refereegranskat)abstract
- We theorize that due to their ability to draw upon the distinctive bonding and bridging social capital resources of their family firm parents, family member spawns have longer early survival times than nonfamily member spawns from family firms, which in turn should have longer early survival times than spawns from nonfamily firm parents. We also predict that the survival enhancing effects of family parent bonding and bridging social capital are conditional on the spatial, cognitive and social proximity between the parent and the spawn. Using a population wide sample of 114,837 spawns founded in Sweden between 2000 and 2007, we find that nonfamily member spawns survive longer than spawns from nonfamily firms, and that this survival enhancing effect is contingent on the spatial and social proximity between the spawn and its parent. We also find that spawns founded by family members, on average, do not survive longer than spawns from family firms founded by nonfamily members, and that greater spatial and cognitive distance even hurt the survival of family member spawns. We discuss the contributions of our research to the spawning, family firm, and entrepreneurship literatures.
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| 4. |
- Davitt, C. J. H., et al.
(författare)
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Alpha-galactosylceramide enhances mucosal immunity to oral whole-cell cholera vaccines
- 2019
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Ingår i: Mucosal Immunology. - : Elsevier BV. - 1933-0219. ; 12, s. 1055-1064
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Tidskriftsartikel (refereegranskat)abstract
- Cholera is a severe diarrheal disease caused by the bacterium Vibrio cholerae (V. cholerae) that results in 3–4 million cases globally with 100,000–150,000 deaths reported annually. Mostly confined to developing nations, current strategies to control the spread of cholera include the provision of safe drinking water and improved sanitation and hygiene, ideally in conjunction with oral vaccination. However, difficulties associated with the costs and logistics of these strategies have hampered their widespread implementation. Specific challenges pertaining to oral cholera vaccines (OCVs) include a lack of safe and effective adjuvants to further enhance gut immune responses, the complex and costly multicomponent vaccine manufacturing, limitations of conventional liquid formulation and the lack of an integrated delivery platform. Herein we describe the use of the orally active adjuvant α-Galactosylceramide (α-GalCer) to strongly enhance intestinal bacterium- and toxin-specific IgA responses to the OCV, Dukoral ® in C57BL/6 and BALB/c mice. We further demonstrate the mucosal immunogenicity of a novel multi-antigen, single-component whole-cell killed V. cholerae strain and the enhancement of its immunogenicity by adding α-GalCer. Finally, we report that combining these components and recombinant cholera toxin B subunit in the SmPill ® minisphere delivery system induced strong intestinal and systemic antigen-specific antibody responses. © 2019, The Author(s).
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| 9. |
- Leijon, Arne, et al.
(författare)
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Analysis of data from the International Outcome Inventory for Hearing Aids (IOI-HA) using Bayesian Item Response Theory
- 2020
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Ingår i: International Journal of Audiology. - : Taylor & Francis. - 1499-2027 .- 1708-8186.
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Tidskriftsartikel (refereegranskat)abstract
- Objective: IOI-HA response data are conventionally analysed assuming that the ordinal responses have interval-scale properties. This study critically considers this assumption and compares the conventional approach with a method using Item Response Theory (IRT). Design: A Bayesian IRT analysis model was implemented and applied to several IOI-HA data sets. Study sample: Anonymised IOI-HA responses from 13273 adult users of one or two hearing aids in 11 data sets using the Australian English, Dutch, German and Swedish versions of the IOI-HA. Results: The raw ordinal responses to IOI-HA items do not represent values on interval scales. Using the conventional rating sum as an overall score introduces a scale error corresponding to about 10 − 15% of the true standard deviation in the population. Some interesting and statistically credible differences were demonstrated among the included data sets. Conclusions: It is questionable to apply conventional statistical measures like mean, variance, t-tests, etc., on the raw IOI-HA ratings. It is recommended to apply only nonparametric statistical test methods for comparisons of IOI-HA results between groups. The scale error can sometimes cause incorrect conclusions when individual results are compared. The IRT approach is recommended for analysis of individual results.
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| 13. |
- Nordqvist, H., et al.
(författare)
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Mutant prevention concentration of colistin alone and in combination with rifampicin for multidrug-resistant Acinetobacter baumannii
- 2016
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Ingår i: European Journal of Clinical Microbiology and Infectious Diseases. - : Springer. - 0934-9723 .- 1435-4373. ; 35:11, s. 1845-1850
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Tidskriftsartikel (refereegranskat)abstract
- Colistin-susceptible isolates of Acinetobacter baumannii often contain subpopulations that are resistant to colistin. Monotherapy with colistin can lead to selective growth of these subpopulations and emergence of colistin-resistant strains. Our objectives were to explore the susceptibility pattern of colistin-resistant subpopulations and investigate if combining colistin with a second antibiotic could prevent their selective growth. Four colistin-susceptible clinical isolates of A. baumannii and one reference isolate were used. The mutant prevention concentration (MPC) of colistin, i.e. the concentration required to block growth of all single-step-mutant subpopulations, was determined by plating an inoculum of 10(9) CFU on Mueller Hinton agar (MHA)-plates containing 2-fold dilutions of colistin (0.125-128 mg/L). Susceptibility testing of colistin-resistant subpopulations, obtained in the MPC assay, was performed with Etest. The MPC of colistin, in combination with rifampicin, was determined by plating an inoculum of 10(9) CFU on MHA-plates containing colistin (0.125-128 mg/L) and fixed concentrations of rifampicin (1.1 mg/L or 4.4 mg/L). The colistin-resistant subpopulations demonstrated increased susceptibility to a number of agents compared to their main populations. These subpopulations were even susceptible to agents that normally are inactive against gram-negative bacteria and all had rifampicin MICs of amp;lt; 0.002 mg/L. The combination of colistin and rifampicin completely inhibited the growth of all colistin-resistant subpopulations and significantly lowered the MPC of colistin for A. baumannii. Combining colistin with rifampicin could be a way to prevent selective growth of colistin-resistant subpopulations of A. baumannii and possibly the emergence of colistin-resistant strains.
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| 16. |
- Sharma, T., et al.
(författare)
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Development of Hillchol (R), a low-cost inactivated single strain Hikojima oral cholera vaccine
- 2020
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Ingår i: Vaccine. - : Elsevier BV. - 0264-410X. ; 38:50, s. 7998-8009
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Tidskriftsartikel (refereegranskat)abstract
- Cholera remains an important global health problem with up to 4 million cases and 140,000 deaths annually. Oral cholera vaccines (OCVs) are now a cornerstone of the WHOs "Ending Cholera - A Global Roadmap to 2030" global program for the eventual elimination of cholera. There are currently three WHO prequalified OCVs available, Dukoral (R), Shanchol (R) and Euvichol-Plus (R). These vaccines are effective but due to a multiple strain composition and two different methods of inactivation, are complex and costly to manufacture. We describe here the characterization and industrial scale development of Hillchol (R); a novel, likely affordable single-component OCV for low and middle-income countries. Hillchol (R) consists of formalin-inactivated bacteria of a stable recombinant Vibrio cholerae O1 El Tor Hikojima serotype strain expressing approximately 50% each of Ogawa and Inaba O1 LPS antigens. The novel OCV can be manufactured on an industrial scale at a low cost. Hillchol (R) was well tolerated in animal toxicology studies and shown to have non-inferior oral immunogenicity in mice for both intestinalmucosal and serological immune responses when compared with a WHO-prequalified OCV. The optimized production of this single component OCV will reduce cost of OCV production and thus substantially increase vaccine availability. Based on these results, Hillchol (R) has been produced at a GMP facility and used successfully for clinical phase I/II studies. (C) 2020 MSD Wellcome Trust Hilleman Laboratories Pvt Ltd. Published by Elsevier Ltd.
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| 17. |
- Sörensen, Lene, et al.
(författare)
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Expanded Screening of One Million Swedish Babies with R4S and CLIR for Post-Analytical Evaluation of Data.
- 2020
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Ingår i: International journal of neonatal screening. - : MDPI AG. - 2409-515X. ; 6:2
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Tidskriftsartikel (refereegranskat)abstract
- Sweden has one neonatal screening laboratory, receiving 115 to 120 thousand samples per year. Among the one million babies screened by tandem mass spectrometry from November 2010 until July 2019, a total of 665 babies were recalled and 311 verified as having one of the diseases screened for with this methodology, giving a positive predictive value (PPV) of 47% and an incidence of 1:3200. The PPV was high (41%) already in the first year after start of screening, thanks to the availability of the collaborative project Region 4 Stork database. The PPV is presently 58%. This improvement was achieved by the implementation of second-tier analyses in the screening for methylmalonic aciduria, propionic aciduria, isovaleric aciduria, and homocystinuria, and the employment of various post analytical tools of the Region 4 Stork, and its successor the collaborative laboratory integrated reports.
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