Case Reports of Situs Inversus Totalis and Dextrocardia in Sprague Dawley Rats

Situs inversus totalis is a condition where there is a transposition of all internal organs from their normal anatomical location. This infrequent and rare congenital condition has been described in several species of mammals. Dextorcardia is a series of conditions associated with an abnormal congenital positioning of the heart, and is often associated with situs inversus totalis. Here we report a case of situs inversus totalis and two cases of dextrocardia identified in Sprague Dawley rats during gross necropsy evaluations at both the Health Sciences North Research Institute (HSNRI) in Canada and Finlay Institute of Vaccine Research and Production in Cuba. The intent of this report is to share our findings and aid in the accumulation of data on these rare conditions

Immunisation schemes with the Cuban vaccine preparation against leptospirosis in hamsters

Se evaluaron diferentes esquemas de inmunización con el preparado vacunal cubano contra la leptospirosis en hámsters, con el objetivo de seleccionar los parámetros óptimos para el ensayo clínico Fase II en humanos. Nueve esquemas de vacunación fueron ensayados, utilizando dos dosis de 0,25; 0,5 y 0,75 mL, con intervalos de 4,6 y 8 semanas entre ellas. La dinámica de anticuerpos se determinó mediante un ensayo inmunoenzimático. Conjuntamente se realizó un estudio de Dosis-Respuesta de la vacuna a diferentes diluciones. Los mayores niveles de inmunogenicidad se lograron con el esquema de vacunación de dos dosis de 0,5 mL con un intervalo de 6 semanas. La vacuna confirió niveles de protección elevados hasta la dilución de 1:4. De acuerdo a estos resultados proponemos el esquema de vacunación antes mencionado para los ensayos clínicos en humanos, así como la evaluación de la dosis de 0,25 mL con intervalo de 6 semanas en el ensayo clínico Fase II.Different immunisation schemes with the Cuban vaccine preparation against Leptospirosis were evaluated in hamsters, in order to choose which one is better to be evaluated in the Clinical Assay Phase II (Immunogenicity) in humans. Nine immunisation schemes were used: doses of 0.25; 0.5 and 0.75 with intervals of 4, 6 and 8 weeks between them. The immunogenicity was measured by an immunoenzymatic assay. At the same time a study of Doses-Response using different dilutions of the vaccine was performed. The highest immunogenic levels were reached with the scheme of two doses of 0.5 mL each one, separated by six weeks. The vaccine provided good protection level until the dilution of 1:4. According to this results we propose the immunisation scheme described above for clinical assays in humans, as well as to evaluate the use of two doses of 0.25 mL with a six week intreval in the clinical assay Phase II.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Immunisation schemes with the Cuban vaccine preparation against leptospirosis in hamsters

Se evaluaron diferentes esquemas de inmunización con el preparado vacunal cubano contra la leptospirosis en hámsters, con el objetivo de seleccionar los parámetros óptimos para el ensayo clínico Fase II en humanos. Nueve esquemas de vacunación fueron ensayados, utilizando dos dosis de 0,25; 0,5 y 0,75 mL, con intervalos de 4,6 y 8 semanas entre ellas. La dinámica de anticuerpos se determinó mediante un ensayo inmunoenzimático. Conjuntamente se realizó un estudio de Dosis-Respuesta de la vacuna a diferentes diluciones. Los mayores niveles de inmunogenicidad se lograron con el esquema de vacunación de dos dosis de 0,5 mL con un intervalo de 6 semanas. La vacuna confirió niveles de protección elevados hasta la dilución de 1:4. De acuerdo a estos resultados proponemos el esquema de vacunación antes mencionado para los ensayos clínicos en humanos, así como la evaluación de la dosis de 0,25 mL con intervalo de 6 semanas en el ensayo clínico Fase II.Different immunisation schemes with the Cuban vaccine preparation against Leptospirosis were evaluated in hamsters, in order to choose which one is better to be evaluated in the Clinical Assay Phase II (Immunogenicity) in humans. Nine immunisation schemes were used: doses of 0.25; 0.5 and 0.75 with intervals of 4, 6 and 8 weeks between them. The immunogenicity was measured by an immunoenzymatic assay. At the same time a study of Doses-Response using different dilutions of the vaccine was performed. The highest immunogenic levels were reached with the scheme of two doses of 0.5 mL each one, separated by six weeks. The vaccine provided good protection level until the dilution of 1:4. According to this results we propose the immunisation scheme described above for clinical assays in humans, as well as to evaluate the use of two doses of 0.25 mL with a six week intreval in the clinical assay Phase II.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Repeat-Dose Toxicity Study Using the AFPL1-Conjugate Nicotine Vaccine in Male Sprague Dawley Rats

Tobacco smoking is the cause of 20% of Canadian deaths per year. Nicotine vaccines present a promising alternative to traditional smoking cessation products, but to date, no vaccine has been able to move through all phases of clinical trials. We have previously demonstrated that the AFPL1-conjugate nicotine vaccine does not induce systemic or immunotoxicity in a mouse model and that a heterologous vaccination approach is more advantageous than the homologous routes to inducing mucosal and systemic anti-nicotine antibodies. The purpose of this study was to confirm the safety profile of the vaccine in a repeat-dose toxicity study. The heterologous vaccination strategy was again used, and Sprague Dawley rats were administered a dose five times greater than in our previous studies. Physiological conditions, food and water consumption, body temperature, injection site inflammation, relative weights of organs, histopathology, and blood chemistry and hematology were evaluated during the course of the vaccination period to determine the safety of the vaccine. The AFPL1-conjugate nicotine vaccine did not induce clinically relevant changes or induce symptoms that would be associated with toxicity, making it a promising candidate for future investigations

Biomodel for evaluating attenuated Vibrio cholerae strains as human cholera vaccine candidates. Study of toxigenicity, immunogenicity and protection

In many countries, Cholera remains being a problem for human health, since it continues being an epidemic or endemic disease, which affects either children or adults and it is a death cause when cholera cases are not treated. A live oral vaccine against this disease can contribute to control important epidemics, mainly at countries where the sanitary hygienic conditions are not good or drinking water is not available. In this work, bio models were selected and applied for the selection of genetically attenuated Vibrio cholerae strains as vaccine candidates against cholera. Their toxigenicity, immunogenicity and protection were evaluated by means of Ileal Loops, intraduodenal inoculation and RITARD models in F1 (New Zealand x White Semi giant) young adults rabbits weighing from 1.8 to 2.3 kg. The results obtained with the used bio models, show that the Vibrio cholerae genetically attenuated strains are no toxigenic, but are immunogenic and protective. As conclusion, these bio models are available for the evaluation and selection of oral vaccine candidates

Diseño, desarrollo y evaluación preclínica de SOBERANA®02: una vacuna cubana contra COVID-19

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