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RISS 인기검색어
- 검색키워드
- 저자 : Ligsay, Antonio D. (검색결과 2 건)
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Russo, Paola,Ligsay, Antonio D.,Olveda, Remigio,Choi, Seuk Keun,Kim, Deok Ryun,Park, Ju Yeon,Park, Ju Yeong,Syed, Khalid Ali,Dey, Ayan,Kim, Yang Hee,Lee, Sung Hee,Kim, Jayoung,Chon, Yun,Digilio, Laura Elsevier Science 2018 Vaccine Vol.36 No.29
<▼1><P><B>Highlights</B></P><P>•<P>Bridging study demonstrating the equivalence of two variations of Euvichol®.</P>•<P>The 600L thimerosal-free Euvichol® is safe and immunogenic in adults and children.</P>•<P>The scale-up of Euvichol® allows expanding global access to oral cholera vaccine.</P></P></▼1><▼2><P><B>Background</B></P><P>To contribute to the global demand for oral cholera vaccine (OCV), the production of Euvichol® was scaled up with elimination of thimerosal. To demonstrate the equivalence of the variations, a study was carried out in the Philippines.</P><P><B>Methods</B></P><P>Healthy male and female adults and children in Manila were randomized to receive two doses of Euvichol® two weeks apart from either the 100L (Comparator) or the 600L (Test) variation. Primary and secondary immunogenicity endpoints were respectively geometric mean titer (GMT) of vibriocidal antibodies (two weeks post second dose) and seroconversion rate (two weeks after each dose) against O1 Inaba, Ogawa, and O139 serogroups. The GMT of vibriocidal antibodies against O1 Inaba, Ogawa, and O139 two weeks post first dose was also measured. To show the equivalence of two variations of Euvichol®, the ratio of GMT and the difference of seroconversion rate between Test and Comparator vaccines were tested with equivalence margin of [0.5, 2.0] for GMT ratio and of 15% for seroconversion rate, respectively. Safety assessment included solicited reactogenicity within 6 days after each dose and unsolicited and serious adverse events.</P><P><B>Results</B></P><P>A total of 442 participants were enrolled. For the overall population, equivalence between Test and Comparator was demonstrated for vibriocidal antibody response against O1 Inaba and Ogawa serotypes and O139 serogroup in both modified intention-to-treat (mITT) and per protocol analysis, since the 95% confidence intervals (CI) of GMT to any serotypes were within the lower and upper boundary [0.5, 2.0]. Seroconversion rates after two doses also showed equivalence for O1 Inaba, Ogawa, and O139. The vaccine was safe and well tolerated, similarly between the two groups.</P><P><B>Conclusion</B></P><P>The study results support the equivalence of the 600L Euvichol® to the 100L formulation in healthy children and adults. The 600L Euvichol® is safe and immunogenic in adults and children.</P><P>ClinicalTrials.gov registration number: NCT02502331.</P></▼2>
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Angelo Jamerlan,Jacqueline Dominguez,Antonio Ligsay,Young Chul Youn,Seong Soo A. An,SangYun Kim 대한독성 유전단백체 학회 2019 Molecular & cellular toxicology Vol.15 No.4
Purpose of review: Chronic traumatic encephalopathy (CTE) is a neurodegenerative disorder that results from repetitive traumatic brain injury (TBI), whether mild or severe. Several popular sports that subject the head to impact have been linked as a primary cause of the disease. Phosphorylated tau and Aβ deposits are the two proteins observed histopathologically in CTE patients. An ischemic environment is created that contributes to the hyperphosphorylation of tau following traumatic brain injury. The use of fluid biomarkers, animal models for TBI, as well as imaging tools are considered valuable in understanding the pathophysiological mechanism of CTE. This review gives particular attention to the characteristics, advantages, and disadvantages of the current fluid biomarkers, use of animal models, and imaging techniques used in CTE diagnosis. Recent findings: Beta-amyloid and phosphorylated tau were suggested as the two main pathological biomarkers for chronic traumatic encephalopathy (CTE) diagnosis, though research into other fluid biomarkers of traumatic brain injury (TBI) such as neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), and C-C motif chemokine 11 (CCL11) has been undertaken but was mostly limited by sample size, and decreased sensitivity in follow-up studies. Animal models and devices that simulate TBI were valuable in exploring injury dynamics and the role it may have on CTE. The use of transgenic animals in CTE research has also uncovered the different risk genes that may enhance CTE pathology. Magnetic resonance imaging (MRI), functional MRI and positron emission tomography (PET) imaging showed enough resolution to accurately diagnose CTE. However, diffusion tensor imaging (DTI) was able to identify microstructural changes in professional boxers that were not apparent in MRI. Currently, a single biomarker or imaging technique is not enough to accurately diagnose CTE and diagnostic accuracy is significantly enhanced when these different parameters are combined.
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