title: Safety of ESAT-6.
abstract: A recombinant dimer of the Mycobacterium tuberculosis (MTb) 6 kDa early secreted antigenic target (ESAT-6) was produced in Lactococcus lactis. Pharmacodynamic and safety studies were carried out in guinea pigs, rats, mice and dogs with intradermal (id), subcutaneous (sc) and intravenous (iv) administration of the antigen. In contrast to tuberculin purified protein derivative (PPD) the recombinant dimer (rdESAT-6) was able to discriminate MTb infection from BCG vaccination in vivo. In guinea pigs sensitized by infection with MTb, 1 microg rdESAT-6 gave a mean delayed-type hypersensitivity (DTH) response of 22 mm, a significantly stronger reaction than in animals sensitised by the environmental mycobacteria M. kansasii, M. szulgai and M. marinum. rdESAT-6 proved to be a safe tuberculin reagent in a dose range of 1-1000 microg with no or only minor local reactions.
authors.affiliation: Statens Serum Institut, Department of Vaccine Development, Artillerivej 5, DK-2300 Copenhagen S, Denmark. hea@ssi.dk
authors.forename: Henrik
authors.initials: H
authors.lastname: Aggerbeck
authors.forename: Søren M
authors.initials: SM
authors.lastname: Madsen
mesh_terms: D000818:Animals; D000942:Antigens, Bacterial; D001500:BCG Vaccine / Q000008:administration & dosage; D001426:Bacterial Proteins; D004285:Dogs; D005260:Female; D006168:Guinea Pigs; D006968:Hypersensitivity, Delayed / Q000276:immunology; D008297:Male; D051379:Mice; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D051381:Rats; D011994:Recombinant Proteins; D016896:Treatment Outcome; D014374:Tuberculin Test / Q000379:methods; D014376:Tuberculosis / Q000175:diagnosis*
chemical_list: D000942:Antigens, Bacterial; D001500:BCG Vaccine; D001426:Bacterial Proteins; C093276:ESAT-6 protein, Mycobacterium tuberculosis; D011994:Recombinant Proteins