14th ICID - Poster Abstracts - International Society for Infectious ...

When citing these abstracts please use the following reference:
Author(s) of abstract. Title of abstract [abstract]. Int J Infect Dis 2010;14S1: Abstract number.
Please note that the official publication of the International Journal of Infectious Diseases 2010, Volume 14, Supplement 1
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Final Abstract Number: 83.010
Session: Vaccines and Vaccine Development
Date: Thursday, March 11, 2010
Time: 12:30-13:30
Room: Poster & Exhibition Area/Ground Level
Type: Poster Presentation
vax-SPIRAL®: Cuban antileptospirosis vaccines for humans: Clinical and field assays and impact
of the vaccine on the disease after 11 years of application in Cuba
R. Martínez
Instituto de Medicina Tropical ¨Pedro Kourí¨, Ciudad Habana, Cuba
Background: In Cuba, leptospirosis has shown an endemoepidemic behavior, with an important
increase in morbility between 1991 and 1995, that is why these years have been considered
epidemic. According to what had been foreseen within the Leptospirosis Prevention and Control
Program, a Russian vaccine was administered to persons at risk of getting the disease since
1983. In 1991, import of this vaccine was stopped and, in order to find an alternative solution to
this health problem, it was decided to start the development of a trivalent Cuban vaccine with
autochthonous strains (Icteroahemorrahgiae, Canicola, Pomona). The objective was to carry out
the clinical evaluation and to observe the impact of the Cuban vaccine against human
leptospirosis in persons exposed to the risk of getting this disease.
Methods: The first studies conducted were controlled clinical assays to evaluate both
reactogenicity and immunogenicity of the vaccine in different groups of volunteers. Nine hundred
and fifty-eight volunteers participated in the studies. To evaluate the vaccine efficacy, a
controlled, randomized, double blind clinical assay was performed in Villa Clara province with 101
832 volunteers, who were followed up for one year. Another studied was carried out in 101 137
persons at risk in Holguin province with the same objective: to evaluate the vaccine effectiveness.
Results: The clinical evaluation showed safety and low reactogenicity. Immunogenicity was
comparable to that of other bacterines. Efficacy was of 78.1% (IC 95%: 58.2 to 88.3) and the RR
of getting sick of vaccinated individuals, with regard to non-vaccinated ones, was 0.22. So, a
protective effect of the vaccine administration was considered. The vax-SPIRAL vaccine was
registered in 1998 and included within the Leptospirosis Prevention and Control Program. Since
the introduction of this vaccine, a marked decrease in leptospirosis cases has been observed. It
has been possible to administered more than 8 million of doses and morbility has been
diminished to 84.1%.
Conclusion: vax-SPIRAL is safe, little reactogenic vaccine and has turned out to be an effective
measure for leptospirosis control in individuals exposed to the risk of getting sick.