title: Skin reactivity to thimerosal and phenol-preserved Montenegro antigen in Brazil.
abstract: A randomized double-blind trial was performed to determine the frequency of positive reactions to the Montenegro antigen (leishmanin) preserved in thimerosal (Merthiolate) 1:10,000 or phenol 0.4%. The respective products were tested separately in 400 young healthy individuals from a non-endemic area for Leishmaniases. Each volunteer received one of the following reagents: merthiolated antigen, phenolated antigen, merthiolated saline, or phenolated saline. The frequency of positive responses to each reagent after the first application was as follows: 0% (phenolated saline), 9.2% (merthiolated saline), 34.6% (antigen in phenolated saline), and 41.1% (antigen in merthiolated saline). After 1 week, volunteers who had tested positive for merthiolated or phenolated antigen were retested with the respective preservative, while negatives were retested with the preservative they had not received during the first test. In all, 331 volunteers who received merthiolated saline during the study, of whom 41 (12.4%) tested positive. Meanwhile, 326 volunteers who received phenolated saline, 4 (1.2%) tested positive. Positive reactions in each group were similar in relation to gross appearance skin reactions. Considering the high frequency of hypersensitivity to thimerosal in the study population, it is recommended that this compound should be replaced as a preservative of the leishmanin antigen. Almost 30% of positive reactions to Montenegro antigen in what is considered a non-endemic region was surprising and will be the object of future studies.
authors.affiliation: Fundação Oswaldo Cruz, Instituto de Pesquisa Clínica Evandro Chagas, Departamento de MicroImunoParasitologia, Serviço de Parasitologia, Av. Brasil, 4365 Manguinhos, Rio de Janeiro, RJ, CEP: 21-045-900, Brazil. aline@ipec.fiocruz.br
authors.forename: Aline
authors.initials: A
authors.lastname: Fagundes
authors.forename: Mauro C A
authors.initials: MC
authors.lastname: Marzochi
authors.forename: Maurício
authors.initials: M
authors.lastname: Perez
authors.forename: Armando
authors.initials: A
authors.lastname: Schubach
authors.forename: Antonio
authors.initials: A
authors.lastname: Ferreira
authors.forename: Janaína P
authors.initials: JP
authors.lastname: Silva
authors.forename: Tânia
authors.initials: T
authors.lastname: Schubach
authors.forename: Keyla B Feldman
authors.initials: KB
authors.lastname: Marzochi
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000953:Antigens, Protozoan / Q000276:immunology*; D001938:Brazil; D004311:Double-Blind Method; D006801:Humans; D007891:Leishmania / Q000302:isolation & purification*; D007896:Leishmaniasis / Q000175:diagnosis / Q000276:immunology*; D008297:Male; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000494:pharmacology*; D012882:Skin Tests / Q000379:methods; D013849:Thimerosal / Q000009:adverse effects / Q000276:immunology / Q000494:pharmacology*
chemical_list: D000953:Antigens, Protozoan; D011310:Preservatives, Pharmaceutical; C032127:leishmanin; D013849:Thimerosal