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New, more effective vaccines to prevent tuberculosis (TB) disease are needed urgently. H4:IC31 is an investigational vaccine that contains a fusion protein of the immunodominant antigens TB10.4 and Ag85B, formulated in IC31® adjuvant. We assessed the safety and immunogenicity of H4:IC31 in South African adults from a TB endemic setting.In this double blind, placebo controlled, phase I trial, Mycobacterium...
An LC–MS/MS method for determination of the break down product of N-ethyl-N′-(3-dimethylaminopropyl) carbodiimide (EDC) urea derivative, EDU, has been developed and validated for monitoring the residual coupling reagents. Results indicate that the method exhibits suitable specificity, sensitivity, precision, linearity and accuracy for quantification of residual EDU in the presence of meningococcal...
The dosage response of humans to conjugate vaccines comprising a bacterial polysaccharide and a strongly-immunogenic carrier protein is determined in animals by coadministering to the animal unconjugated strongly-immunogenic carrier protein in an amount corresponding, on a weight-related basis, to that administered to the human.
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