Author: Valdés, Yolanda ; Sierra, Gustavo ; González, Marta ; Suárez, Miguel ; Naranjo, Mariela ; Amador, Nelly ; Fernández, Carmen ; Infante, Juan F ; Batista, Niurka ; González, Irma

Honduras was one of the Central American countries most severely hit by Hurricane Mitch. Torrential rains and heavy flooding created conditions conducive to a leptospirosis outbreak in the country. A group of Cuban scientists studied 68 patients from the Department of Cort�s - one of the country's hardest hit areas - presenting clinical and epidemiological profiles indicative of leptospirosis. Blood and serum samples were taken from all subjects. A microscopic agglutination test (MAT) was used to identify Leptospira strains and to assess protection conferred by vax-SPIRAL® (Cuban leptospirosis vaccine) against the isolated strain. Prevalence of leptospires in the kidneys and liver was also verified. A male predominance was found in the group aged 15-49 years. Municipalities in this Department with the largest number of cases were San Pedro Sula, La Lima, and Chamelec�n. The most frequent symptoms included fever, headache, myalgia, and generalized discomfort. Over 80% of subjects reported presence of rodents in their homes, as well as contact with stagnant water and domestic animals. The strain isolated from positive blood cultures was from the Icterohaemorrhagiae serogroup, which was highly virulent in the animal model used. Protection was 100% in hamsters inoculated with vax-SPIRAL® and subsequently challenged with the Honduran strain. Additionally, macroscopic analysis of organs from immunized animals that survived the challenge showed no signs of leptospirosis infection.

Revista cubana de medicina tropical

[Scale-up of the fermentation of Leptospira interrogans canicola canicola for the production of vax-SPIRAL vaccine].

Article

Author: Hernández, Damián Rojo ; Torres, Florinda Hernández ; Enrique, Kenia Fernández ; Airado, Janet Lazo ; Boué, Raúl Gutiérrez ; Zamora, José Daniel Benítez

The operational conditions for the production of vaccine vax-SPIRAL were established at the scale of 100 L. It was concluded that it should be carried out with an air flow of 10 L/min (0.1 vvm) and without mechanical agitation.

Revista cubana de medicina tropical

[Response of antileptospira IgG antibodies in individuals immunized with vax-SPIRAL].

Article

Author: Rodríguez, José Enrique ; Fernández, Carmen ; Obregón, Ana Margarita ; Martínez, Raydel ; Zamora, Yarelys ; Rodríguez, Islay

A quantitative ELISA for the detection of IgG antibodies in response to the Cuban vaccine against the human leptospirosis (vax-SPIRAL) was applied to 930 volunteers'sera, 483 immunized with vax-SPIRAL and 447 with a vaccine against hepatitis B. Samples were taken before beginning the study, 21 days after the second dose and a year later. A high seroprevalence of antibodies to the vaccine serovars was observed before beginning the study. The initial value of the response doubled at 21 days of the second dose in 45 % of the individuals. There were markedly significant differences (p=0,000000) between both groups. A similar response to the three leptospiral serovars was found. After the year the levels of antibodies decreased; however, 23.1% of the individuals were able to duplicate their level of antibodies regarding the initial moment, and the significant difference with the group that received the vaccine against hepatitis B still existed. The application of this Cuban immunogen amomg the main risk groups was recommended.

100 Deals associated with Leptospirosis vaccine trivalent (Finlay Institute)

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Indication	Country/Location	Organization	Date
Leptospirosis	Cuba	-	01 Jan 1998

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leptospirosis	Phase 2	Indonesia	Abivax SA	12 Nov 2014
Leptospirosis	Phase 2	India	Abivax SA	12 Nov 2014
Leptospirosis	Phase 2	Philippines	Abivax SA	12 Nov 2014
Leptospirosis	Phase 2	Brazil	Abivax SA	12 Nov 2014
Leptospirosis	Phase 2	Uruguay	Abivax SA	12 Nov 2014
Leptospirosis	Phase 2	Mexico	Abivax SA	12 Nov 2014

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Leptospirosis vaccine trivalent (Finlay Institute)

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