Two different potency tests were evaluated, consisting in one-dilution used to determine 50% lethal dose (LD50) and four--dilution used to calculate 50% effective dose (ED50), respectively. Our experience has led to propose the four-dilution test for routine lot releasing.

http://scielo.sld.cu/pdf/mtr/v57n1/mtr20105.pdf

Evaluation of two different potency tests for leptospirosis vaccine vax-SPIRAL®

Leptospirosis is a neglected disease causing severe infections in humans and animals. Due in part to misdiagnosis, this infectious disease results in nearly 60,000 deaths per year around the globe. This study represents the first effort to describe the diversity of pathogenic Leptospira in Cuba based on whole-genome sequencing. We have collected nineteen whole-blood samples from patients that were diagnosed as having leptospirosis between 2008 and 2012 in Cuba. In addition, we have enhanced our sample set by three historical strains that were used for the development of a human vaccine in 1990s. The Leptospira strains were grown and serotyped by the microscopic agglutination test, and the draft genomes were generated by NGS (Illumina). Subsequently, the core genomes were analyzed and compared to the genetic data available from other Caribbean islands and countries in Central America. Core genome Multi-locus Sequence Typing (cgMLST) revealed four different core genome clonal groups (cgCGs), with the highest number of samples belonging to L. interrogans, followed by L. borgpetersenii and L. kirschneri. All cgCGs that were found in Cuba have been also identified from multiple origins across the globe, except in neighbor countries and Central America. Serotyping divided the samples into the serogroups Canicola, Ballum and Pomona. The most frequent cgCGs, cgCG28, associated with serogroup Canicola, and cgCG15, associated with serogroup Ballum, have also been identified from samples isolated from dogs, rodents, and pigs; suggesting that these hosts represent the major source of human infection in Cuba. The vaccine strains did not significantly differ from the recent patient isolates. However, the increasing prevalence of samples belonging to the serogroup Ballum combined with the fact that the available vaccine in Cuba represents inactivated Leptospira belonging to serogroups other than Ballum, should be a valuable information for the National and Regional Leptospirosis Control Programs.

/pdf/a-first-insight-into-the-genomic-diversity-of-leptospira-2lnfnqperk.pdf

A first insight into the genomic diversity of Leptospira strains isolated from patients in Cuba

Se evaluaron por vez primera en Cuba las tecnologias serologicas rapidas para realizar la pesquisa y confirmacion de la leptospirosis humana, que mundialmente estan disponibles. Su reconocimiento clinico resulta dificil, y el diagnostico etiologico rapido es de vital importancia. Se obtuvieron valores de sensibilidad y especificidad superiores a 90 % en los sistemas confirmatorios y de 85 % en el de pesquisa. De los pacientes graves estudiados por estas tecnologias 50 % fue positivo, ademas se confirmaron 203 casos pertenecientes a 4 brotes epidemicos, asi como 12 enfermos vacunados con vaxSPIRAL®, demostrandose la eficacia de la vacuna (78,1 %). Se desarrollo y aplico un sistema latex para pesquisa rapida de leptospirosis (LeptoCuba), con excelente sensibilidad, especificidad, reproducibilidad y estabilidad. La aplicacion de nuevas tecnologias a la pesquisa y confirmacion rapida de la enfermedad, permitio incrementar la positividad y calidad del diagnostico en el periodo 2002-2006, fortaleciendose la vigilancia microbiologica en el pais.

Avances de laboratorio en el diagnóstico serológico y la investigación de la leptospirosis humana en Cuba

Whole cell Leptospirosis vaccines have been developed and used from the 20 ` s of last century up today , most of them are not adjuvated and do not confer a long-lasting immunity. These vaccines are mainly against different serogroups of Leptospira interrogans contained in the preparation. Though several attempts to obtain a vaccinal formulation more effective, purer, with wider spectrum and longer protection than the bacterines of inactivated whole cells have been made no vaccine with these characteristics have been registered yet. This paper deals with the obtainment of outer membrane antigens from a Cuban autochthonous strain (Strain 87, L. interrogans serovar Canicola), by a modification of the technology for the production of outer membrane vesicles, patented by researchers from Finlay institute These antigens with nanoproteoliposomic structure were formulated/adjuvated by different strategies, obtaining five preparations with cochlear structures which are nanoparticles of approximately 100 to 150 nm of lenght and from 15 to 30 nm of diameter. Two doses of the immunogens are inoculated in the biomodel Mesocrisetus aureatus, with an interval of six weeks. The challenge was carried out with 100.000 DL 50 . Results showed that the new vaccinal formulations confer protection against the homologous challenge and were able to eliminate the carrier status. This, together with the robutness of the preparation method, the higher level of purity, compared to the bacterines, and the no need of aluminium hydroxide make the formulations an alternative of interest for continuing their development.

/pdf/proteccion-inducida-por-nanococleatos-derivados-de-4x4m9i74z5.pdf

Protección inducida por nanococleatos derivados de proteoliposomas de Leptospira interrogans serovar Canicola

/pdf/laboratory-advances-about-human-leptospirosis-in-cuba-1989-2i77wl85w9.pdf

Laboratory advances about human leptospirosis in Cuba, 1989-2016.

/pdf/vax-spiral-vacuna-antileptospirosica-trivalente-para-uso-34i1fzp2r0.pdf

vax-SPIRAL ® . Vacuna antileptospirósica trivalente para uso humano; investigación, desarrollo e impacto sobre la enfermedad en Cuba

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vax-SPIRAL ® . Vacuna antileptospirósica trivalente para uso humano; investigación, desarrollo e impacto sobre la enfermedad en Cuba