[Efficacy and safety of a vaccine against human leptospirosis in Cuba].

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.