Raydel Martínez, Alberto Pérez, María del C Quiñones, Raúl Cruz, Angel Alvarez, Marlén Armesto, Carmen Fernández, Jorge Menéndez, Islay Rodríguez, Morelia Baró, Manuel Díaz, José Rodríguez, Gustavo Sierra, Ana Margarita Obregón, María Eugenia Toledo, Norma Fernández
OBJECTIVES: To evaluate the efficacy of vax-SPIRAL, a Cuban vaccine against leptospirosis, and to provide additional information concerning the safety of this vaccine (which was developed by Cuba's Finlay Institute). METHODS: This phase III efficacy trial of vax-SPIRAL was controlled, randomized, and double blind. The control vaccine used for the trial was Heberbiovac-HB (Heber Biotec, Cuba), a recombinant hepatitis B vaccine. The randomization unit for allocating persons to the study group or the control group were 523 family physician offices in the selected municipalities...
April 2004: Pan American Journal of Public Health