Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 35
Filter
1.
Medisur ; 20(5): 885-894, sept.-oct. 2022. graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1405976

ABSTRACT

RESUMEN Fundamento: las arbovirosis continúan siendo un problema de salud en el mundo y en Cuba. La vigilancia de estas enfermedades es hoy prioridad en muchos países. Objetivo: describir el actual sistema de vigilancia de las arbovirosis en Cienfuegos durante el año 2019. Métodos: se realizó una investigación en sistemas y servicios de salud. Se exploraron 10 servicios de vigilancia. El sistema se describió en términos de: componentes, definición de caso, fuentes y flujo de datos, arquitectura tecnológica y tipos de vigilancia. Se realizó revisión documental, aplicación de una lista de chequeo, entrevistas a informantes claves y análisis de serie cronológica de arbovirosis 2014-2019. Resultados: la vigilancia se articula en red a través de sus componentes. La definición de caso se modifica en períodos epidémicos. Existen varias fuentes de datos de las cuales se nutre el sistema, algunas recogen información no útil para la vigilancia. La vigilancia basada en indicadores es la que se utiliza, no así la vigilancia basada en eventos y no existe un sistema informatizado que integre toda la información lo cual puede limitar su validez. Conclusiones: el sistema de vigilancia de las arbovirosis en Cienfuegos comparte características con los que se desarrollan a nivel internacional, sin embargo se identificaron limitaciones que pueden conspirar con el funcionamiento de algunos de sus atributos, cuestión que habría que explorar en próximos estudios.


ABSTRACT Background: arboviruses continue to be a health problem in the world and in Cuba. Surveillance of these diseases is now a priority in many countries. Objective to describe the current arbovirus surveillance system in Cienfuegos during 2019. Methods The research was carried out in health systems and services. 10 surveillance services were explored. The system is described in terms of: components, case definition, data sources and flow, technological architecture, and types of surveillance. A documentary review, application of a checklist, interviews with key informants and analysis of the chronological series of arboviruses 2014-2019 were carried out. Results: surveillance is articulated in a network through its components. The case definition is modified in epidemic periods. There are several data sources from which the system feeds, some collect information that is not useful for surveillance. Surveillance based on indicators is what is used, but surveillance based on events is not, and there is no computerized system that integrates all the information, which can limit its validity. Conclusions: the arbovirus surveillance system in Cienfuegos shares characteristics with those developed internationally, however, limitations were identified that may conspire with the functioning of some of its attributes, an issue that should be explored in future studies.

2.
Rev. cuba. salud pública ; 48(1): e2987, ene.-mar. 2022. tab
Article in Spanish | LILACS, CUMED | ID: biblio-1409267

ABSTRACT

Introducción: La hospitalización por enfermedades diarreicas agudas en menores de cinco años de edad puede generar gastos importantes para la familia. Objetivo: Estimar el gasto de bolsillo y el costo indirecto por la atención a pacientes menores de cinco años de edad hospitalizados por gastroenteritis a causa de rotavirus. Métodos: Estudio de descripción de costos. Se empleó el microcosteo para estimar el costo directo médico (servicio y medicamentos) y no médico (transporte, alimentación, aseo), así como las pérdidas de productividad para el paciente y su familia y las fuentes de financiamiento. Se trabajó con 132 pacientes hospitalizados en el Hospital Pediátrico de Cienfuegos entre septiembre de 2019 y febrero de 2020 con gastroenteritis y test rápido de rotavirus positivo. El gasto se analizó según la situación económica referida y la edad del paciente. Resultados: La media del gasto de bolsillo total fue de CUP 809,66 (IC 95 por ciento 757,57 - 861,75); el 50,8 por ciento por alimentación, el 31,4 por ciento por aseo y un 17,8 por ciento por transportación. Los hogares con mejor situación económica gastaron más (< 0,001). El 87,2 por ciento de las familias utilizó alguna fuente de recursos adicional a sus ingresos habituales. Se afectaron 2,39 personas (IC 95 por ciento 2,27 - 2,52) y se reportó una pérdida de 5,51 días laborales (IC 95 por ciento 5,21 - 5,8). El costo indirecto promedio fue de CUP 418,8 (IC 95 por ciento 382,36 - 455,24). Conclusiones: La hospitalización de un menor de cinco años por gastroenteritis aguda a causa de rotavirus en Cienfuegos significa una carga económica considerable para los hogares, en especial para los de mejor situación económica(AU)


Introduction: Hospitalization for acute diarrheal diseases in children under five years of age can generate significant expenses for the family. Objective: To assess the out-of-pocket expense and the indirect cost for the care of patients under five years of age hospitalized for gastroenteritis due to rotavirus. Methods: This is cost description study. Microcosting was used to estimate the direct medical cost (service and medication) and non-medical cost (transportation, food, cleaning), as well as the productivity losses for patients and their family and the sources of financing. We worked with 132 patients hospitalized at Cienfuegos Pediatric Hospital from September 2019 to February 2020 with gastroenteritis and a positive rotavirus rapid test. Expenditure was analyzed according to the economic situation referred to and the age of the patient. Results: The mean total out-of-pocket expense was CUP 809.66 (95percent CI 757.57 - 861.75); 50.8percent for food, 31.4percent for cleaning and 17.8percent for transportation. Households with better economic situation spent more (<0.001). 87.2percent of the families used some source of resources in addition to their usual income. 2.39 people were affected (95percent CI 2.27 - 2.52) and a loss of 5.51 working days was reported (95percent CI 5.21 - 5.8). The average indirect cost was CUP 418.8 (95percent CI 382.36 - 455.24). Conclusions: The hospitalization of a child under five years of age for acute gastroenteritis due to rotavirus in Cienfuegos represents a considerable economic burden for families, especially for those with better economic situation(AU)


Subject(s)
Humans , Male , Female , Child, Preschool , Pediatrics , Health Expenditures , Gastroenteritis/epidemiology , Hospitalization/economics
3.
Medisur ; 19(6)dic. 2021.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1405867

ABSTRACT

RESUMEN Fundamento El estudio de los costos de la hospitalización por gastroenteritis por rotavirus es un tema estratégico ante la disyuntiva de introducir o no una vacuna contra rotavirus en Cuba. Objetivo estimar el costo institucional de hospitalización de pacientes menores de cinco años de edad por gastroenteritis a causa de rotavirus. Métodos estudio descriptivo, específicamente una evaluación económica parcial del tipo descripción de costos. Se utilizó el costo modelado por protocolo de atención ajustado a la práctica habitual. Fueron revisados los documentos normativos y se aplicó un ejercicio de ajuste a la práctica de rutina mediante consulta a expertos. El costo fue expresado en CUP de 2018. Resultados se estimó el ingreso en sala de Gastroenterología para el 93,1 % de los pacientes, de los cuales el 99,4 % resolvería el problema de salud. El salario resultó la partida de mayor aporte al gasto, aunque en la sala de Gastroenterología lo fueron los exámenes complementarios. El costo de hospitalización promedio modelado para la gastroenteritis por rotavirus fue de 435,13 CUP; este varió según la condición clínica con que arribe el paciente, entre 415,72 CUP y 1057,60 CUP. El costo fue sensible a la variación de la estadía en los servicios. Conclusión La hospitalización de un paciente menor de cinco años por gastroenteritis a causa de rotavirus representa altos gastos para el hospital. El servicio de atención a pacientes críticos y el ingreso previo en una sala clínica distinta a la de gastroenterología incrementan el costo de la atención.


ABSTRACT Background The study of the hospitalization costs for rotavirus gastroenteritis is a strategic issue given the dilemma of introducing or not a rotavirus vaccine in Cuba. Objective to estimate the institutional cost of hospitalization of patients younger than five years of age because of gastroenteritis due to rotavirus. Methods descriptive study, specifically a partial economic evaluation of the costs description type. Modeled cost per care protocol adjusted to standard practice was used. The normative documents were reviewed and an adjustment exercise was applied to routine practice by consulting experts. The cost was expressed in 2018 Cuban pesos. Results admission to the Gastroenterology ward was estimated for 93.1% of the patients, of which 99.4% would solve the health problem. The salary was the item with the highest contribution to spending, although in the Gastroenterology ward it was the complementary examinations. The average cost of hospitalization modeled for rotavirus gastroenteritis was 435.13 Cuban pesos; this varied according to the clinical condition with which the patient arrives, between 415.72 pesos and 1057.60 pesos. The cost was sensitive to the variation of the stay in the services. Conclusion Hospitalization of a patient younger than five years of age for gastroenteritis due to rotavirus represents high costs for the hospital. The attention service to critical patients and the previous admission to a clinical room other than that of Gastroenterology, increase the cost of care.

4.
Vaccimonitor (La Habana, Print) ; 30(2)mayo.-ago. 2021. tab, graf
Article in Spanish | CUMED, LILACS | ID: biblio-1252327

ABSTRACT

La gastroenteritis causada por rotavirus constituye un importante problema de salud mundial, por lo que se recomienda incluir la vacunación contra el rotavirus en los programas de inmunización. Para evaluar el impacto de una futura introducción en Cuba de una vacuna contra este patógeno, resulta necesario crear una línea de base pre-vacunación de la carga de la gastroenteritis causada por este virus. Entre noviembre 2017 a abril 2018 se implementó en el Hospital Pediátrico de Centro Habana un sistema de vigilancia para la gastroenteritis causada por rotavirus. Se establecieron las definiciones para las categorías de caso sospechoso, probable y confirmado. Por cada niño captado se recogió una muestra de heces que se analizó con tiras rápidas y se confirmó la presencia de rotavirus por ELISA. Para determinar la severidad de la enfermedad se utilizó la escala de Vesikari. Los resultados fueron expresados en cifras absolutas y relativas, el análisis se realizó a través de la prueba de chi-cuadrado. Del total de ingresos por enfermedad diarreica aguda, el 26 por ciento cumplió los criterios de inclusión y el 46 por ciento resultó confirmado como rotavirus. El hacinamiento en el hogar y asistir al círculo infantil se comportaron como factores de riesgo. El servicio de gastroenterología absorbió la mayor carga de ingresos hospitalarios por esta causa. Los resultados mostrados validan la funcionalidad del sistema de vigilancia implementado y brindan nuevas evidencias sobre la carga de la enfermedad y la utilización de los servicios de un hospital pediátrico cubano, debido a la gastroenteritis provocada por rotavirus, lo que justifica la introducción de la vacuna(AU)


Gastroenteritis caused by rotavirus is a major global health problem, therefore it is recommended that vaccination against rotavirus be included in immunization programs. To evaluate the impact of a future introduction in Cuba of a vaccine against this pathogen, it is necessary to have a pre-vaccination baseline of the burden of gastroenteritis caused by rotavirus. Between November 2017 and April 2018, a surveillance system for gastroenteritis caused by rotavirus was implemented in the Paediatric Hospital of Centro Habana. Definitions were established for the categories of suspected, probable and confirmed cases. For each captured child, stool samples were collected, analyzed with rapid strips and confirmated by ELISA. To determine the severity of the disease, the Vesikari score was used. The results were expressed in absolute and relative figures; the analysis was performed through chi-square. Of the total admissions for acute diarrheal disease, 26 percent met the inclusion criteria and 46 percent were confirmed for rotavirus. Overcrowding at home and attending a day care center were risk factors. The gastroenterology service absorbed the greatest burden of hospital admissions for this cause. The results shown validate the role of the implemented surveillance system and provide new evidence on the burden of disease and use of services for rotavirus gastroenteritis in a cuban pediatric hospital(AU)


Subject(s)
Humans , Male , Female , Child, Preschool , Rotavirus Infections/prevention & control , Risk Factors , Rotavirus Vaccines , Diarrhea/etiology , Gastroenteritis/epidemiology , Epidemiology, Descriptive , Prospective Studies , Cuba , Observational Studies as Topic
5.
Rev. habanera cienc. méd ; 20(2): e3759, mar.-abr. 2021. tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1251799

ABSTRACT

Introducción: La colonización nasofaríngea por neumococo se define como el momento inicial en el que la bacteria se aloja en la nasofaringe del individuo. Objetivo: Estimar la proporción de factores de riesgo asociados a la colonización nasofaríngea por neumococo en niños vacunados con vacunas conjugadas antineumocócicas (PCV). Material y Métodos: Un año después de la vacunación antineumócocica mediante un ensayo clínico fase II/III, controlado, aleatorizado y doble ciego en niños de 1 a 5 años, se ejecutó un estudio de seguimiento con un diseño casos y controles, tipo caso-caso. El horizonte temporal fue desde noviembre de 2015 hasta abril de 2016. Se incluyó 50 por ciento del total de vacunados en el estudio experimental. El universo lo constituyó los 1 135 niños vacunados en el ensayo clínico. Se siguió un muestreo aleatorio simple y se incluyeron 555 sujetos. Se realizó una encuesta y una toma de muestra de exudado nasofaríngeo. Se presentaron tablas de frecuencias. Se utilizó la razón de prevalencia como medida de asociación. Se calcularon los intervalos de confianza a 95 por ciento para cada proporción. Resultados: Tener entre 2 y 5 años actúa como factor protector para la colonización nasofaríngea con respecto al niño pequeño. Convivir con personas mayores de 65 años constituye un factor de riesgo significativamente relacionado con la colonización nasofaríngea. Conclusiones: La introducción de vacunas antineumocócicas en niños preescolares puede impactar de manera significativa la carga de colonización y en la trasmisión de la enfermedad neumocócica(AU)


Introduction: Nasopharyngeal colonization by pneumococci is defined as the initial moment when the bacterium lodges in the nasopharynx of the person. Objective: To estimate the proportion of risk factors associated with nasopharyngeal colonization by pneumococci in children vaccinated with conjugate pneumococcal vaccines (CPV). Material and Methods: One year after pneumococcal vaccination, a follow-up case-case-control study was conducted in children aged 1-5 years by means of a phase II/III controlled, randomized, double-blind clinical trial. The time horizon was from November 2015 to April 2016. The study included 50 percent of the total of children vaccinated during the experimental study. The universe consisted of 1135 children who were vaccinated during the clinical trial. A simple random sampling that included 555 persons was applied. A survey was conducted and nasopharyngeal exudate samples were taken. Tables of frequencies were presented. Prevalence ratio was used as a measure of association. Also, 95 percent confidence intervals were calculated for each proportion. Results: Being between the ages of 2-5 years acts as protective factor against nasopharyngeal colonization with respect to the young child. Living with persons older than 65 years is a significantly associated risk factor with nasopharyngeal colonization. Conclusions: The introduction of pneumococcal vaccines in pre-school children can have a significant impact on colonization burden and the transmission of pneumococcal diseases(AU)


Subject(s)
Humans , Male , Child, Preschool , Pneumococcal Infections , Simple Random Sampling , Pneumococcal Vaccines , Case-Control Studies , Risk Factors , Prevalence Ratio
6.
Vaccimonitor (La Habana, Print) ; 30(1)ene.-abr. 2021. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1150251

ABSTRACT

Contar con datos confiables de la incidencia de la invaginación intestinal en la población infantil cubana es un paso necesario previo a la introducción de la vacuna contra el rotavirus. Con el objetivo de profundizar en el conocimiento de los hallazgos clínicos y epidemiológicos de la invaginación intestinal en niños menores de 1 año, se realizó un estudio epidemiológico en el servicio de cirugía pediátrica del Hospital Pediátrico Docente Centro Habana entre noviembre de 2017 a abril de 2018. El estudio constituye el precursor de un sistema de vigilancia centinela de base hospitalaria que será parte del proyecto Vacuna contra rotavirus promovido por el Instituto Finlay de Vacunas. Los datos de todos los casos notificados se recolectaron por los cirujanos a través de la Ficha de vigilancia centinela de la invaginación intestina. Se notificaron un total de nueve casos con diagnóstico de invaginación intestinal, principalmente a los 5 meses de edad (44,4 por ciento), todos confirmados por ecografía de abdomen. La incidencia de invaginación intestinal en este período fue estimada de 1,41 por ciento. Los síntomas y signos más frecuentes fueron las deposiciones con sangre (77,8 por ciento), la irritabilidad (66,7 por ciento) y el vómito (55,6 por ciento). La desinvaginación por técnicas no quirúrgicas fue empleada en ocho casos y de ellas, el enema con aire fue la más usada (62,5 por ciento). Los resultados presentados aportan información necesaria para la construcción de la línea base de la invaginación intestinal en niños menores de 1 año de edad, antes de la introducción de la vacunación contra rotavirus en Cuba(AU)


The knowledge of the baseline incidence rates of intussusception among infants in Cuba are necessary to introduce the rotavirus vaccine into the Cuban immunization schedule. With the aim of characterizing the clinical presentation and epidemiology of intussusception a surveillance study was performed in children less than 1 years old with intussusception, in the pediatric surgery service at the Centro Habana Pediatric Hospital in Havana city between November 2017 and April, 2018. This study is the precursor of an active sentinel hospital surveillance for intussusception in children under 1 year of age, as a part of the project Rotavirus vaccine promoted by Instituto Finlay de Vacunas. Data were collected for each notified case by surgeons using a brief study questionnaire (Sentinel surveillance file for intussusception). A total of nine patients were diagnosed with intussusception, most cases presented at 5 months of age (44.4 percent), and all cases were confirmed by abdominal ultrasonography. The incidence of intussusception was 1.41 percent. The most frequent symptoms were rectal bleeding (77.8 percent), irritability (66.7 percent) and vomiting (55.6 percent). Intussusceptions reduction by non-surgical methods was used in eight cases, mainly air enema (62.5 percent). These results are now available to build the body of scientific evidence for baseline rates of intussusception in children less than 1 year of age, prior to the introduction of the rotavirus vaccine in Cuba(AU)


Subject(s)
Humans , Male , Female , Child, Preschool , Child , Rotavirus Vaccines/therapeutic use , Intussusception , Epidemiology, Descriptive , Cuba
8.
Int J Infect Dis ; 97: 182-189, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32474199

ABSTRACT

OBJECTIVES: To evaluate the cost-effectiveness of introducing a domestic pneumococcal conjugate vaccine (PCV7-TT) into the Cuban National Immunization Program (NIP). METHODS: We compared PCV7-TT given at two, four and six months of age to a scenario without PCV7-TT, over a ten-year period (2020-2029). We calculated the cost (Cuban pesos - CUP) per Disability Adjusted Life Year (DALY) averted from a Government perspective. We compared results from a static cohort model and a parsimonious prediction model informed by the serotype distribution among pneumococcal carriers and cases. We ran probabilistic and deterministic uncertainty analyses. RESULTS: PCV7-TT could prevent 6897 (95% uncertainty interval, 4344-8750) hospitalizations and 189 (115-253) deaths in children <5 years of age, over the period 2020-2029. This could cost around 25 million (20-31) discounted CUP but would be offset by treatment cost savings of around 23 million (14-31). A parsimonious model predicted less favourable impact and cost-effectiveness but the cost per DALY averted was still less than 0.4 times the current GDP per capita. CONCLUSIONS: PCV7-TT is likely to be cost-effective in Cuba. The impact of the vaccine would need to be carefully monitored following its introduction into the NIP.


Subject(s)
Immunization Programs/economics , Pneumococcal Infections/economics , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/administration & dosage , Pneumococcal Vaccines/economics , Algorithms , Child, Preschool , Cohort Studies , Cost-Benefit Analysis , Cuba , Female , Health Care Costs , Hospitalization/economics , Humans , Infant , Male , Pneumococcal Infections/immunology , Pneumococcal Infections/microbiology , Pneumococcal Vaccines/immunology , Quality-Adjusted Life Years , Streptococcus pneumoniae/immunology , Vaccines, Conjugate/administration & dosage , Vaccines, Conjugate/economics , Vaccines, Conjugate/immunology
10.
In. Hernández Rodríguez, Alberto Inocente; Orta Hernández, Santa Deybis. Consideraciones sobre ensayos clínicos. Experiencias en Cuba. La Habana, Editorial Ciencias Médicas, 2020. , tab, ilus.
Monography in Spanish | CUMED | ID: cum-76400
11.
Rev. cuba. salud pública ; 45(3)jul.-sep. 2019.
Article in Spanish | LILACS, CUMED | ID: biblio-1508503

ABSTRACT

En la actualidad, existe la certeza de que las vacunas comerciales disponibles contra rotavirus producen un impacto en la reducción de las hospitalizaciones y consultas médicas asociadas a la enfermedad diarreica que causa este virus. Se conoce que, en los países pobres, e incluso en los en vía de desarrollo, los costos para sostener un programa de inmunización que incluya vacunas contra rotavirus son relativamente elevados. En el presente trabajo se realiza la revisión de algunos estudios de costo-efectividad relacionados con la introducción de estas vacunas en contextos diversos, a partir de que se reconoce su efectividad e impacto en la población infantil vacunada. El objetivo es contribuir al conocimiento de investigadores, médicos, profesionales de la salud, directivos y autoridades encargados de la toma de decisiones para la introducción de una vacuna contra rotavirus en Cuba(AU)


The available evidence for commercial rotavirus vaccines supports an impact on the reduction in hospitalizations and medical consultations associated with rotavirus diarrheal disease. However, it is also known that for poor and even developing countries, the costs of sustaining an immunization program that includes rotavirus vaccines are relatively high. This paper presents a synthesis of cost-effectiveness studies related to the introduction of rotavirus vaccination in diverse contexts, based on the recognition of existing evidence on the effectiveness and impact of the vaccinated child population. In this way, it seeks to contribute to the body of knowledge and information among researchers, physicians, and health professionals, but also directors and authorities in charge of making decisions for the introduction of a rotavirus vaccine in Cuba(AU)


Subject(s)
Humans , Rotavirus Infections/epidemiology , Rotavirus Vaccines , Cost-Effectiveness Analysis/methods , Vaccines , Cuba
12.
MEDICC Rev ; 21(1): 37-38, 2019 01.
Article in English | MEDLINE | ID: mdl-31242151

ABSTRACT

The process of research and evaluation of new products and technologies requires a combination of transdisciplinary theoretical and methodological approaches for managing and achieving objectives. The research, development and evaluation strategy of the new Cuban pneumococcal vaccine combines the approaches of team science and accelerated vaccine introduction. These frameworks are proposed for discussions regarding biotech product evaluation, using their application to the Pneumococcus Project as an example. Emphasis is on the use of team science to eliminate obstacles to obtaining a product of great scientific and technological complexity while establishing robust scientific evidence to support its use and marketing. All of this is in support of opportune and efficient decisions for accelerated introduction of new vaccines in Cuba.


Subject(s)
Biomedical Research , Interdisciplinary Research , Pneumococcal Vaccines/therapeutic use , Biomedical Research/methods , Biomedical Research/organization & administration , Cuba , Humans , Interdisciplinary Research/methods , Interdisciplinary Research/organization & administration , Pneumococcal Infections/prevention & control
13.
F1000Res ; 8: 1922, 2019.
Article in English | MEDLINE | ID: mdl-35340438

ABSTRACT

In the African meningitis belt (region from Senegal to Ethiopia), there are around 30,000 reported cases of meningococcal disease per year. The main aetiological agent is Neisseria meningitidis of serogroup A. Since 2010, vaccination efforts have increased and hundreds of millions of people have been vaccinated. There are indications that the epidemiology of meningococcal disease is changing. This is the protocol of a scoping review, the objective of which is to describe the extent and nature of the research evidence about the impact of vaccination on meningitis frequency. Primary studies and reviews are eligible for inclusion in the review if they assess the impact of interventions that include N. meningitidis vaccination in countries of the African meningitis belt, report meningitis frequencies, and include an element of comparison. The sources of records are electronic databases (MEDLINE, Cochrane register of clinical trials, African Index Medicus, and clinicaltrials.gov), surveillance reports at country level, online resources of large stakeholders involved in vaccination, reference lists of included records, and experts in the field. The search strategy is based on the combination of the condition of interest, the intervention, and the geographical region. The findings of this review will be presented using figures, tables, and thematic narrative synthesis. This review will not produce a pooled estimate of what the impact of vaccination is, but will give insight in how the authors of the included records assessed the impact.

14.
Vaccine ; 36(32 Pt B): 4944-4951, 2018 08 06.
Article in English | MEDLINE | ID: mdl-30005948

ABSTRACT

BACKGROUND: Cuba has a new pneumococcal conjugate vaccine candidate (PCV7-TT). This study evaluates the safety and immunogenicity in healthy infants using 2p+1 vaccination schedule. METHODS: A phase I, controlled, randomized and double blind clinical trial was designed. 30 unvaccinated healthy infants were included. 20 subjects were assigned to study group (PCV7-TT) and 10 to control group (Synflorix®) to receive the vaccines at 7, 8 months of age (primary series) and 11 months (booster dose). Blood samples were collected 30 days after second dose and post booster for antibodies measure analysis by ELISA and OPA. The statistics analysis included the frequency of occurrence for adverse events and the immune response. Non-parametric tests were used to compare the immune response. The clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173 available at http://registroclinico.sld.cu. RESULTS: Overall, the safety profile of PCV7-TT was similar to Synflorix®. Local reactions were predominant and systemic events were mild in severity. Swelling and redness were frequently associated with PCV7-TT mainly after the first dose (50% and 40% respectively). 15% and 10% of subject reported severe swelling after first dose with PCV7-TT and after second dose with Synflorix®. Mild fever (≥38-≤39), vomiting and sleep disturb were the systemic events reported. 100% of infants achieved pneumococcal IgG antibody concentrations ≥0.35 µg/ml after booster dose for serotypes 1, 14, 18C and 19F in each vaccine group. For serotypes 5, 6B and 23F, more than 80% infants vaccinated with Synflorix® or PCV7-TT achieved protective IgG GMC ≥ 0.35 µg/ml after booster dose. OPA proportion's responders to the seven common serotypes were 89.5% or more after the primary dose and 100% after booster dose in vaccinated with PCV7-TT. CONCLUSIONS: The Cuban PCV7-TT is safe, well tolerated and immunogenic in healthy infants.


Subject(s)
Heptavalent Pneumococcal Conjugate Vaccine/therapeutic use , Pneumococcal Infections/prevention & control , Vaccines, Conjugate/therapeutic use , Antibodies, Bacterial/immunology , Double-Blind Method , Female , Heptavalent Pneumococcal Conjugate Vaccine/administration & dosage , Humans , Immunization Schedule , Infant , Male , Pneumococcal Infections/immunology , Vaccines, Conjugate/administration & dosage
15.
Medisur ; 16(3): 410-416, may.-jun. 2018.
Article in Spanish | LILACS | ID: biblio-955071

ABSTRACT

Fundamento: El Streptococcus pneumoniae forma parte de la flora bacteriana normal de la mucosa nasal y faríngea. La colonización nasofaríngea antecede a la enfermedad neumocócica y los individuos afectados constituyen el reservorio a nivel comunitario.Objetivo: determinar la prevalencia de colonización nasofaríngea global y por serotipos de Streptococcus pneumoniae en niños de 1 a 5 años institucionalizados, previo a la vacunación antineumocócica.Métodos: se realizó un estudio descriptivo de corte transversal en el municipio de Cienfuegos, en el período comprendido de junio del 2014 hasta abril del 2015, en niños de edades entre 1 y 5 años, que asisten a círculos infantiles (N=1 129). Las muestras de exudado nasofaríngeo se tomaron siguiendo los protocolos establecidos. Se estimó la prevalencia de colonización y se identificaron los serotipos más frecuentes.Resultados: la prevalencia global de colonización nasofaríngea por neumococos fue de 32,32 %. Los serotipos vacunales más frecuentes fueron el 19F (6,02 %) y el 6B (3,99 %); de los relacionados con la vacuna, predominó el 6A (5,49 %) y de los no vacunales, el más observado fue el 14B.Conclusión: la colonización nasofaríngea en niños preescolares no vacunados contra el neumococo presentó una prevalencia elevada, a expensas de los serotipos incluidos en las vacunas conjugadas antineumocócicas.


Foundation: Streptococcus pneumoniae is part of the normal bacterial flora of the nasal and pharingeal mucosa. Naso-pharyngeal colonization precedes the pneumococcal disease and affected individuals are a reservoir at the community level.Objective: to determine the prevalence of global naso-pharyngeal colonization and by serotypes of Streptococcus pneumoniae in children of pre-school age before anti pneumoccocal vaccination.Methods: a cross descriptive study in the Cienfuegos Municipality, within the period of June 2014 and April 2015. in children aged between 1 and 5 years attending preschool educative centers (N=1 129). Samples of naso-pharyngeal exudates were taken following the set guidelines. The prevalence of colonization was estimated and the most frequent serotypes were identified.Results: the global prevalence of naso-pharyngeal colonization was 32,32 %. The most frequent vaccine serotypes were 19F (6,02 %) and 6B (3,99 %); of those related with the vaccine, 6A predominated (5,49 %) and of the not related to the vaccine the most frequently observed was 14B.Conclusion: naso-pharyngeal colonization in preschool children not vaccinated against pneumoccocus presented a high prevalence at the expense of the serotypes included in the conjugated anti-peumococcal vaccines.

16.
Rev. cuba. salud pública ; 44(2)abr.-jun. 2018.
Article in Spanish | CUMED | ID: cum-73482

ABSTRACT

El proceso de investigación y evaluación de nuevos productos y tecnologías necesita de la combinación de enfoques teóricos y metodológicos transdiciplinarios para la gestión y consecución de los objetivos. La estrategia de investigación, desarrollo y evaluación de la nueva vacuna cubana contra neumococo combina las perspectivas de Ciencia en Equipo e Introducción acelerada de nuevas vacunas. Se presenta como debate la adopción de estos marcos en el contexto de evaluación de productos de la biotecnológicos y se ejemplifica su aplicación al Proyecto Neumococo. Se enfatiza en cómo la eliminación de obstáculos en la obtención de un producto de alta complejidad científica y tecnológica y la conformación de un cuerpo de evidencias científicas robustas que soportan su uso y comercialización, constituyen los principales resultados aportados por los que asumen el enfoque de ciencia en equipo, en favor de una toma de decisiones oportunas y eficientes para la introducción acelerada de nuevas vacunas en Cuba(AU)


The process of research and evaluation of new products and technologies requires the combination of theoretical and methodological transdisciplinary approaches for the management and achievement of the objectives. The research, development and evaluation strategy of the new Cuban pneumococcal vaccine combines the perspectives of Team Science and Accelerated introduction of new vaccines. The adoption of these frameworks in the context of evaluation of biotechnological products is presented as a debate and the application to the Pneumococcal Project is exemplified. Emphasis is on how the elimination of obstacles in obtaining a product of high scientific and technological complexity, and the conformation of a body of robust scientific evidence that supports its use and commercialization constitute the main results contributed by those who assume the team science approach, in favor of timely and efficient decision making for the accelerated introduction of new vaccines in Cuba(AU)


Subject(s)
Humans , Pneumococcal Vaccines/therapeutic use , Research Groups , Cuba
17.
Rev. cuba. salud pública ; 44(2)abr.-jun. 2018.
Article in Spanish | LILACS, CUMED | ID: biblio-901568

ABSTRACT

El proceso de investigación y evaluación de nuevos productos y tecnologías necesita de la combinación de enfoques teóricos y metodológicos transdiciplinarios para la gestión y consecución de los objetivos. La estrategia de investigación, desarrollo y evaluación de la nueva vacuna cubana contra neumococo combina las perspectivas de Ciencia en Equipo e Introducción acelerada de nuevas vacunas. Se presenta como debate la adopción de estos marcos en el contexto de evaluación de productos de la biotecnológicos y se ejemplifica su aplicación al Proyecto Neumococo. Se enfatiza en cómo la eliminación de obstáculos en la obtención de un producto de alta complejidad científica y tecnológica y la conformación de un cuerpo de evidencias científicas robustas que soportan su uso y comercialización, constituyen los principales resultados aportados por los que asumen el enfoque de ciencia en equipo, en favor de una toma de decisiones oportunas y eficientes para la introducción acelerada de nuevas vacunas en Cuba(AU)


The process of research and evaluation of new products and technologies requires the combination of theoretical and methodological transdisciplinary approaches for the management and achievement of the objectives. The research, development and evaluation strategy of the new Cuban pneumococcal vaccine combines the perspectives of Team Science and Accelerated introduction of new vaccines. The adoption of these frameworks in the context of evaluation of biotechnological products is presented as a debate and the application to the Pneumococcal Project is exemplified. Emphasis is on how the elimination of obstacles in obtaining a product of high scientific and technological complexity, and the conformation of a body of robust scientific evidence that supports its use and commercialization constitute the main results contributed by those who assume the team science approach, in favor of timely and efficient decision making for the accelerated introduction of new vaccines in Cuba(AU)


Subject(s)
Humans , Pneumococcal Vaccines/therapeutic use , Research Groups , Cuba
18.
Int J Infect Dis ; 60: 98-102, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28457742

ABSTRACT

A new pneumococcal conjugate vaccine is currently undergoing advanced clinical evaluation prior to its planned introduction in Cuba. The implementation of the pneumococcal vaccination strategy has been designed with consideration of the need to maximize both its direct and indirect effects. A novel approach is suggested, which addresses preschool children as the first-line target group to generate herd immunity in infants and to have an impact on transmission at the community level. The clinical evaluation pipeline is described herein, including evaluations of effectiveness, cost-effectiveness, and impact. The scientific contribution of the Cuban strategy could support a paradigm shift from individual protection to a population effect based on a rigorous body of scientific evidence.


Subject(s)
Immunity, Herd , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines , Vaccination/standards , Child, Preschool , Cost-Benefit Analysis , Cuba , Humans , Infant , Nasopharynx/microbiology , Pneumococcal Infections/epidemiology , Pneumococcal Vaccines/economics , Pneumococcal Vaccines/immunology , Pneumococcal Vaccines/standards , Streptococcus pneumoniae/immunology , Streptococcus pneumoniae/isolation & purification , Vaccination/economics , Vaccines, Conjugate/economics , Vaccines, Conjugate/immunology , Vaccines, Conjugate/standards
19.
Pediatr Infect Dis J ; 36(1): e22-e28, 2017 01.
Article in English | MEDLINE | ID: mdl-27649366

ABSTRACT

BACKGROUND: A new vaccine candidate against pneumococcus is being developed in Cuba, and it is a priority of the national health system. There is limited information on nasopharyngeal colonization burden, though it is essential for monitoring the impact of the vaccine. The study aims to estimate the prevalence of nasopharyngeal colonization in children 2-18 months of age and identify circulating serotypes, antimicrobial resistance and its association with selected risk factors. METHODS: A cross-sectional study was conducted between October and December 2013 in Cienfuegos municipality. Inclusion criteria were evaluated, and informed consent was obtained from the parents. Clinical and epidemiologic data were collected through a semistructured questionnaire. Nasopharyngeal swabs according to established protocols were taken. Data analysis included frequency distributions and comparison of proportions. The association between colonization and selected risk factors was assessed by multivariate analysis. RESULTS: A total of 984 children (87.2% living in urban areas) were included. The overall prevalence of colonization was 21.6%. The most frequent serotypes isolated were 6A (23.1%), 23F (10.8%), 6B (10.3%), 19F (8.5%) and 14 (3.3%). We found no resistance to ß-lactamases in circulating serotypes. Living with sibling younger than 5 years, previous respiratory infections, previous hospitalization and day-care attendance were determinants of nasopharyngeal carriage. CONCLUSIONS: The findings suggest that the burden of pneumococcal disease and colonization in Cuba could be significantly affected after vaccine introduction.


Subject(s)
Carrier State/epidemiology , Pneumococcal Infections/epidemiology , Pneumococcal Vaccines/immunology , Streptococcus pneumoniae/isolation & purification , Vaccination/statistics & numerical data , Carrier State/immunology , Carrier State/microbiology , Cross-Sectional Studies , Cuba/epidemiology , Female , Humans , Infant , Male , Microbial Sensitivity Tests , Pneumococcal Infections/immunology , Pneumococcal Infections/microbiology , Pneumococcal Infections/prevention & control , Prevalence , Risk Factors , Serogroup , Streptococcus pneumoniae/immunology
SELECTION OF CITATIONS
SEARCH DETAIL
...