RESUMO
In this work, we produced and evaluated a vaccine based on a ß toxoid of Clostridium perfringens type C produced in Escherichia coli (rBT). The non-toxic rBT was innocuous for mice and induced 14 IU mL(-1) of ß antitoxin in rabbits, complying with the European Pharmacopeia and CFR9 - USDA guidelines.
Assuntos
Vacinas Bacterianas/biossíntese , Clostridium perfringens/imunologia , Toxoides/biossíntese , Vacinas Sintéticas/biossíntese , Animais , Toxinas Bacterianas/genética , Vacinas Bacterianas/genética , Vacinas Bacterianas/toxicidade , Escherichia coli , Camundongos , Camundongos Endogâmicos BALB C , Coelhos , Toxoides/genética , Toxoides/toxicidade , Vacinação , Vacinas Sintéticas/genética , Vacinas Sintéticas/toxicidadeRESUMO
Two different potency tests were evaluated, consisting in one-dilution used to determine 50% lethal dose (LD50) and four--dilution used to calculate 50% effective dose (ED50), respectively. Our experience has led to propose the four-dilution test for routine lot releasing.
Assuntos
Vacinas Bacterianas/normas , Leptospira/imunologia , Leptospirose/prevenção & controle , Animais , Vacinas Bacterianas/toxicidade , Cricetinae , Cuba , Seguimentos , Leptospira/patogenicidade , Dose Letal Mediana , Fatores de Tempo , Testes de ToxicidadeRESUMO
The single-dose toxicological test for the leptospirosis vaccine vax-SPIRAL was made in rats. No clinical toxicity symptoms were found. The differences between the evaluated variables were not important from the biological point of view.
Assuntos
Vacinas Bacterianas/toxicidade , Leptospira interrogans/imunologia , Leptospirose/prevenção & controle , Testes de Toxicidade , Animais , Vacinas Bacterianas/administração & dosagem , Modelos Animais de Doenças , Feminino , Masculino , Camundongos , Fatores de TempoRESUMO
The comparative study of two group B meningococcal vaccines manufactured in the USSR and in Cuba was made. The vaccine manufactured in the USSR contained the noncovalent compound of group B Neisseria meningitidis polysaccharide and outer membrane protein, and the Cuban vaccine contained group B N. meningitidis outer membrane proteins and group C N. meningitidis polysaccharide. The data obtained in this study indicated that both vaccines possessed immunological potency evaluated according to their capacity to stimulate the formation of bactericidal antibodies, whose level was found to increase eightfold after the immunization of monkeys in two injections. Besides, group B meningococcal vaccines did not induce the suppression of nonspecific protective activity characteristics of the body and did not stimulate the formation of autoantibodies to brain and liver tissues, which was indicative of the safety of these vaccines.