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- 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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| 5. |
- Herbert, Roger B, et al.
(författare)
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Granular iron reactive barriers for the degradation of chlorinated solvents in groundwater
- 2000
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Ingår i: Vatten. - 0042-2886. ; 56:4, s. 261-266
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Tidskriftsartikel (refereegranskat)abstract
- This paper presents the results of batch and column experiments that investigated the degradation of chlorinated solvents bv zerovalent granular iron. These experiments were designed to produce data essential for the installation of a field-scale permeable reactive barrier at a field site with groundwater contaminated bv perchloroethylene (PCE) and other less chlorinated ethenes. The batch tests were conducted in order to identify a suitable iron product for the reactive matrix in a barrier. The test results indicated that an American iron product, because of its greater surface area, was superior in the degradation of PCE relative to other selected granular iron products. The column experiments were designed to determine the rates of PCE, TCE and cis-DCE removal and the column residence times needed to achieve solvent degradation. For a column composed of a mixture of 50% granular iron and 50% sand, the results showed that the time for a 50 % decrease (t50) in solvent concentration was < 1.3 hours for PCE, ca. 1.4 hours for TCE, and ca. 1.9 hours for cis-DCE. These results can be used to dimension a field-scale reactive barrier, where the groundwater residence time must be in excess of these t50 values.
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| 7. |
- Kirdok, Emrah, et al.
(författare)
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Metagenomic analysis of Mesolithic chewed pitch reveals poor oral health among stone age individuals
- 2024
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Ingår i: Scientific Reports. - : Springer Nature. - 2045-2322. ; 13:1
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Tidskriftsartikel (refereegranskat)abstract
- Prehistoric chewed pitch has proven to be a useful source of ancient DNA, both from humans and their microbiomes. Here we present the metagenomic analysis of three pieces of chewed pitch from Huseby Klev, Sweden, that were dated to 9,890-9,540 before present. The metagenomic profile exposes a Mesolithic oral microbiome that includes opportunistic oral pathogens. We compared the data with healthy and dysbiotic microbiome datasets and we identified increased abundance of periodontitis-associated microbes. In addition, trained machine learning models predicted dysbiosis with 70-80% probability. Moreover, we identified DNA sequences from eukaryotic species such as red fox, hazelnut, red deer and apple. Our results indicate a case of poor oral health during the Scandinavian Mesolithic, and show that pitch pieces have the potential to provide information on material use, diet and oral health.
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| 8. |
- Landström, Fredrik J., 1966-, et al.
(författare)
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Electroporation therapy for T1 and T2 oral tongue cancer
- 2011
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Ingår i: Acta Oto-Laryngologica. - : Informa Healthcare. - 0001-6489 .- 1651-2251. ; 131:6, s. 660-664
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Tidskriftsartikel (refereegranskat)abstract
- Conclusion: Electroporation therapy appears to be a safe treatment achieving excellent local tumor control and very good functional results in our study and it should be further clinically evaluated.Objectives: The objectives of this study were to assess local tumor control, survival, and effects on speech and eating after treatment of tongue cancer with electroporation therapy, a new local therapeutic modality. In this approach intracellular accumulation of a chemotherapeutic agent is achieved by using a locally applied electrical field.Methods: Fifteen patients with primary T1 and T2 oral tongue cancer were treated with electroporation therapy with intratumorally administered bleomycin. Postoperative radiotherapy was performed when the tumor infiltration was 5 mm or more. The follow-up time was 24 months for the surviving patients and 20.4 months overall. The effects on eating and speech were assessed using the PSS-HN scale and voice recordings.Results: No local recurrence was recorded in any patient during the follow-up. Three patients died, two from progressive regional disease. Of the 12 surviving patients, 2 patients had regional recurrence and 10 patients including the 5 patients treated with EPT alone were tumor-free both locally and regionally at the last follow-up. The functional outcome for speech and eating were very good.
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| 10. |
- 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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