title: [Reactogenecity and immunogenecity of Cuban trivalent inactivated vaccine against human leptospirosis in different vaccination schedules].
abstract: A controlled, randomized assay was performed to evaluate the reactogenecity and immunogenecity of Cuban trivalent vaccine against human leptospirosis (vax-SPIRAL) in healthy volunteers, using different vaccination schemes. A Russian-made vaccine was used as control. Adverse effects were local symptoms and signs (pain, rush, local infiltration, itching, necrosis and abscess) and general symptoms and signs(fever, low-grade fever, headache, lipotimia, nausea, vomiting, rash and general malaise). The results showed that the vaccine is innocuous since no serious adverse effects were observed. Low-grade fever and slight local pain were the symptoms and signs that occurred at acceptable levels. Fever was present in a small number of volunteers. Similar adverse reactions were reported in the groups immunized with Cuban vaccine under different vaccination schemes and in those immunized with the Russian-made vaccine. Most of the symptoms and signs disappeared after 72 hours. Seroconversion was similar to other bacterines against leptospirosis. The achieved results allowed concluding that the Cuban vaccine is safe and low reactogenic for human adults.
authors.affiliation: Especialista de I Grado en Epidemiología, Instituto de Medicina Tropical "Pedro Kouri" (IPK), Ciudad de La Habana, Cuba. cupk@ipk.sld.cu
authors.forename: Raydel Martínez
authors.initials: RM
authors.lastname: Sánchez
authors.forename: Alberto Pérez
authors.initials: AP
authors.lastname: Sierra
authors.forename: Ana Margarita
authors.initials: AM
authors.lastname: Obregón Fuentes
authors.forename: Islay Rodríguez
authors.initials: IR
authors.lastname: González
authors.forename: Alberto Baly
authors.initials: AB
authors.lastname: Gil
authors.forename: Morelia Baró
authors.initials: MB
authors.lastname: Suárez
authors.forename: José Rodríguez
authors.initials: JR
authors.lastname: Silveira
authors.forename: Bermond Delfina
authors.initials: BD
authors.lastname: Gastón
mesh_terms: D001428:Bacterial Vaccines / Q000276:immunology*; D006801:Humans; D007919:Leptospira / Q000276:immunology*; D007922:Leptospirosis / Q000517:prevention & control*; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors
chemical_list: D001428:Bacterial Vaccines