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pubmed-article:10715532pubmed:abstractTextMucosal immune responses are known to play important roles in the establishment of protective immunity to microbial infections through mucosa. We examined the toxic effects of recombinant cholera toxin B subunit (rCTB) secreted by Gram-positive bacterium Bacillus brevis as a mucosal adjuvant. Incubation of guinea-pig peritoneal macrophages with cholera toxin (CT) or aluminium hydroxide gel (Al-gel) released a significantly higher activity of lactate dehydrogenase than did commercial natural CTB (CTB) or rCTB. Intraintestinal or intramuscular administration of CT, CTB or Al-gel caused severe histopathological reactions. CT also caused infiltration of neutrophils and irregular arrangement or partial loss of the respiratory epithelium. In addition, CT and CTB elicited vascular permeability-increasing effects. rCTB elicited no toxic effects to macrophages and no vascular permeability-increasing effects. Moreover, it is noticeable that no distinct local histopathological reactions were observed in the nasal cavity, the small-intestinal loop or the muscle given rCTB. These results suggest that, from a safety standpoint, rCTB is a useful candidate as mucosal vaccine adjuvant.lld:pubmed
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pubmed-article:10715532pubmed:dateRevised2006-11-15lld:pubmed
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pubmed-article:10715532pubmed:articleTitleSafety evaluation of recombinant cholera toxin B subunit produced by Bacillus brevis as a mucosal adjuvant.lld:pubmed
pubmed-article:10715532pubmed:affiliationDepartment of Safety Research on Biologics, National Institute of Infectious Diseases, Gakuen, Musashimurayama, Tokyo, Japan. ngoto@nih.go.jplld:pubmed
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pubmed-article:10715532pubmed:publicationTypeResearch Support, Non-U.S. Gov'tlld:pubmed
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