title: [Evaluation of the effectiveness of a new vaccine against human leptospirosis in groups at risk].
abstract: In order to evaluate the effectiveness of a new vaccine against human leptospirosis, a prospective cohort study was done with persons in the Cuban province of Holguín who were at risk of becoming ill with leptospirosis. The study included 118,018 persons from 15 to 65 years old who were considered to face either permanent or temporary risk. The vaccinated cohort consisted of 101,137 persons. They received two vaccine doses, 6 weeks apart, of 0.50 mL via deep intramuscular injection into the deltoid muscle of the nondominant arm. The unvaccinated cohort consisted of 16,881 persons. Epidemiological surveillance began 21 days after the application of the second vaccine dose and continued for 1 year. The same criteria for suspected and confirmed cases were maintained throughout the study period. At the end of the surveillance period effectiveness was calculated as being higher than 97%. It is estimated that the vaccination program prevented eight out of ten cases that would have otherwise occurred. Vaccine reactogenicity was also measured in a subsample of 1,500 persons between 15 and 65 years old. The observed symptomatology was low. Slight pain at the injection site was the most frequent symptom (25%). The results of the study indicate the usefulness of the vaccine for disease prevention among people at risk, and its use is thus recommended.
authors.affiliation: Instituto de Medicina Tropica Pedro Kourí, Ciudad de La Habana, Cuba.
authors.forename: R
authors.initials: R
authors.lastname: Martínez Sánchez
authors.forename: A
authors.initials: A
authors.lastname: Pérez Sierra
authors.forename: M
authors.initials: M
authors.lastname: Baró Suárez
authors.forename: A M
authors.initials: AM
authors.lastname: Alvarez
authors.forename: J
authors.initials: J
authors.lastname: Menéndez Hernández
authors.forename: M
authors.initials: M
authors.lastname: Díaz González
authors.forename: R
authors.initials: R
authors.lastname: Cruz de la Paz
authors.forename: G
authors.initials: G
authors.lastname: de los Reyes
authors.forename: B
authors.initials: B
authors.lastname: Montoya Batista
authors.forename: G
authors.initials: G
authors.lastname: Sierra González
authors.forename: M
authors.initials: M
authors.lastname: Armesto del Río
authors.forename: A
authors.initials: A
authors.lastname: Saltarén Cobas
authors.forename: O
authors.initials: O
authors.lastname: Sabournin Ramos
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D015331:Cohort Studies; D003462:Cuba; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007273:Injections, Intramuscular / Q000379:methods; D007919:Leptospira / Q000276:immunology*; D007922:Leptospirosis / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012306:Risk
chemical_list: D001428:Bacterial Vaccines
vernacular_title: Evaluación de la efectividad de una nueva vacuna contra la leptospirosis humana en grupos en riesgo.