bVibrio parahaemolyticus is a halophilic bacterium that is widely distributed in water resources. The bacterium causes lethal food-borne diseases and poses a serious threat to human and animal health all over the world. The major pathogenic factor of V. parahaemolyticus is thermolabile hemolysin (TLH), encoded by the tlh gene, but its toxicity mechanisms are unknown. A highaffinity antibody that can neutralize TLH activity effectively is not available. In this study, we successfully expressed and purified the TLH antigen and discovered a high-affinity antibody to TLH, named scFv-LA3, by phage display screening. Cytotoxicity analysis showed that scFv-LA3 has strong neutralization effects on TLH-induced cell toxicity. Vibrio parahaemolyticus, a Gram-negative motile bacterium that inhabits marine and estuarine environments throughout the world (7,23,36), is a major food-borne pathogen that causes life-threatening diseases in humans through the consumption of raw or undercooked seafood (5,21,34 It is well known that V. parahaemolyticus contains many different kinds of toxins, such as thermostable direct hemolysin (TDH), TDH-related hemolysin (TRH), and some noncharacterized proteins. TDH is considered one of the major virulence factors of V. parahaemolyticus, and its function has been well characterized and discussed (25). TRH is another hemolysin of V. parahaemolyticus that can also lyse red blood cells, and it has high sequence homology with TDH (24, 42). However, identifying the pathogenic serovars of V. parahaemolyticus by use of only these two toxins is not sufficiently accurate, as other hemolysins may take part in the pathogenicity of V. parahaemolyticus. Thermolabile hemolysin (TLH), a toxin encoded by the tlh gene of V. parahaemolyticus and present in almost every clinical and environmental V. parahaemolyticus strain (14, 37), has been suggested as a promising target for pathogen detection (30,35,44). Although TLH has hemolytic activity and can lyse red blood cells, its cytotoxic and biochemical mechanisms of action are still not clearly understood (3,26,31). Since TLH may be as important as TDH and TRH (6), it is necessary to investigate its function during the process of infection.Single-chain variable-fragment (scFv) antibody generation is a versatile technology for generating antibodies that are specific for a given antigen (40). It has also been used for selective molecular targeting in cancer research for conditions such as lymphatic invasion vessels, colon cancer, and hepatocarcinoma (27,29,33,43). Furthermore, scFv antibody generation has been used extensively to generate ligands for detecting pathogenic germs in vitro and in vivo (8,22,38,39). Compared to polyclonal antibodies or hybridoma technology, scFv antibodies can easily be manipulated genetically to improve their specificity and affinity, reducing production costs. In addition, they can be fused with molecular markers for immunological detection of pathogenic bacteria (10, 28). scFv antibody generation has also been used extensively in vitr...
study reports (18 studies), 1 SAS® database pooling data from 16 studies and 1 SAS® database composed of 1 study. While pooling data from these different sources, several issues had to be faced: 1) the need to harmonize data between studies; 2) the fact that some variables were not collected in some studies, and 3) the fact that for 6 studies, part of the data were available only as summarized data. After taking into account all these issues, an exploitable database was obtained whose strengths are its large sample size (35 studies comprising 7923 patients), its range of study settings and designs (phase I to IV across numerous countries) and the time period encompassed (1990 to 2007). CONCLUSIONS: Pooling data from various sources raised several problems, not all of them resolvable. However, this work allowed to obtain an exploitable database with undisputable strengths i.e. sample size, large range of study settings and design and time period encompassed. Once constituted, this database became a valuable tool in evaluating the safety profile of the virosomal aluminium-free hepatitis A vaccine, and will constitute a valuable database to answer further safety questions in the future. OBJECTIVES:Many pharmacoeconomic studies have applied the decision analytic model or Markov model (collectively termed as static models) to evaluate the costeffectiveness of pneumococcal conjugate vaccines without taking herd effect into account. The objective of the study is to carry out a cost-effectiveness analysis of 13-valent pneumococcal conjugate vaccine PCV13 in Taiwan using a transmission dynamic model (TDM) to circumvent static models. METHODS: We develop an age-structured TDM populated with parameters from the Taiwanese National Health Insurance Research Database (NHIRD), Centers for Disease Control, government websites and public available sources to evaluate the clinical and economic impact of PCV13. Pneumococcal diseases included in the TDM are invasive pneumococcal diseases (IPD), hospitalized pneumonia and acute otitis media (AOM). One-way deterministic and multivariate probabilistic sensitivity analyses based on 5000 Monte Carlo simulations are performed to explore model uncertainties. Confidence intervals for ICER and cost-effectiveness acceptability curves (CEAC) are calculated for further inferences. RESULTS: In the base-case analysis, 4-dose scheduled universal infant PCV13 vaccination is expected to prevent 5,112 cases of IPD, 535,607 cases of all-cause hospitalized pneumonia, 726,986 cases of AOM, and 420 deaths over a 10-year time horizon. The vaccination program is estimated to yield an incremental cost-effectiveness ratio (ICER) of US$38,045 and US$18,299 from payer and societal perspectives. One-way sensitivity analyses indicated that ICER is most sensitive to vaccine price and recovery rate of pneumonia. Ninety-five percent confidence interval of ICER is US$10,186 to US$34,563 by multivariate probabilistic sensitivity analyses in societal perspective. CONCLUSIONS: With a WHOrecommended cost-effectiveness t...
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