ABSTRACT
La existencia de agentes biológicos como el virus de la peste porcina clásica para la producción de vacunas veterinarias, entre otros de igual importancia para nuestro país y la región en general, justifica una buena gestión de la seguridad biológica, ya que el desconocimiento del riesgo por parte del personal que labora en estas vacunas puede provocar contaminaciones de graves consecuencias medio ambientales, en el proceso de producción y a nivel personal si son causantes de accidentes fatales. El objetivo de la investigación fue realizar un análisis de la percepción de riesgo existente en el personal responsable del proceso de producción de la vacuna contra la peste porcina clásica. La aplicación del RISKPERCEP en el personal de la instalación de producción de la vacuna de la peste porcina clásica mostró como resultados el comportamiento de diferentes variables que hacen evidente la alta subestimación del riesgo existente en el personal evaluado y que existe la necesidad de profundizar en la formación en bioseguridad para todo el personal que labora en el proceso. Finalmente, se relacionan estos temas y su importancia para mejorar la calidad de la producción en estos procesos, así como incrementar el conocimiento acerca del riesgo biológico a todos los niveles(AU)
The existence of high-risk biological agents such as the classical swine fever virus for the production of veterinary vaccines, among others of equal importance for our country and the region in general, justifies good management of biological safety, since ignorance of the risk on part of the personnel who work in them, can cause contamination with serious consequences both at personal and environmental level, causing fatal accidents. The objective of the research was to carry out an analysis of the perception of existing risk in the personnel responsible for the production process of the vaccine against classical swine fever. The application of RISKPERCEP in the classical swine fever vaccine production facility showed as results the behavior of different variables that make evident the high underestimation of the existing risk in the evaluated personnel and that there is a need to deepen the training in biosafety to all staff working in the process. Finally, these issues and their importance to improve the quality of production in these processes are related, as well as to increase knowledge about biological risk at all levels(AU)
Subject(s)
Animals , Bacterial Vaccines/adverse effects , Viral Vaccines/adverse effects , Risk Factors , Classical Swine Fever/prevention & control , SwineABSTRACT
OBJETIVO: avaliar a compreensão das informações do Termo de Consentimento Livre e Esclarecido pelos participantes de uma pesquisa clínica de vacina contra o Zika vírus. MÉTODO: estudo transversal com amostra por conveniência e participação de 101 voluntários de uma pesquisa clínica em Belo Horizonte, Minas Gerais. Utilizou-se um questionário estruturado. A análise dos dados foi realizada no programa R, segundo a estatística descritiva e inferencial. RESULTADOS: a média de acertos dos participantes sobre as informações do documento de consentimento foi de 66,9%. A maioria dos participantes assinou o documento sem o conhecimento suficiente das informações da pesquisa. O Índice de compreensão foi maior entre os participantes que tinham se voluntariado em pesquisas prévias (p=0,039). CONCLUSÃO: verificaram-se limitações importantes na compreensão dos participantes sobre informações do termo de consentimento, o que comprometeu a decisão autônoma. São necessárias adaptações e melhorias nos processos de consentimento informado em prol da sua validade.
OBJECTIVE: to assess the understanding of the information contained in the Informed Consent Form by the participants of a clinical trial of a vaccine against the Zika virus. METHOD: cross-sectional study using intentional sampling, including a total of 101 volunteers in clinical research in Belo Horizonte, Minas Gerais. A structured questionnaire was used. Data analysis was performed using R software, according to descriptive and inferential statistics. RESULTS: the mean of correct answers of the participants regarding the information in the consent form was 66.9%. Most participants signed the document without sufficient knowledge of the research information. The comprehension index was higher among participants who had volunteered in previous research (p=0.039). CONCLUSION: there were important limitations in the participants' understanding of information in the consent form, which compromised the autonomous decision. Adaptations and improvements are necessary in the processes of informed consent for its validity.
OBJETIVO: evaluar la comprensión de las informaciones contenidas en el Término de Consentimiento Libre e Informado por los participantes de un ensayo clínico de una vacuna contra el virus del Zika. MÉTODO: estudio transversal con muestra de conveniencia y participación de 101 voluntarios en una investigación clínica en Belo Horizonte, Minas Gerais. Se utilizó un cuestionario estructurado. El análisis de datos se realizó mediante el programa R, según estadística descriptiva e inferencial. RESULTADOS: el promedio de aciertos de los participantes con respecto a las informaciones del documento de consentimiento fue de 66,9%. La mayoría de los participantes firmó el documento sin conocimiento suficiente de las informaciones de la investigación. El índice de comprensión fue mayor entre los participantes que se habían ofrecido como voluntarios en investigaciones anteriores (p=0,039). CONCLUSIÓN: hubo limitaciones importantes en la comprensión de las informaciones del formulario de consentimiento por parte de los participantes, lo que comprometió la decisión autónoma. Son necesarias adecuaciones y mejoras en los procesos de consentimiento informado para su validez.
Subject(s)
Humans , Male , Female , Adult , Young Adult , Viral Vaccines , Comprehension , Zika Virus , Informed Consent , Cross-Sectional Studies , Controlled Clinical Trials as Topic , Ethics, ResearchABSTRACT
OBJECTIVES@#To investigate the serum level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific RBD IgG antibody (SARS-CoV-2 IgG antibody for short) in children with SARS-CoV-2 Omicron variant infection during the recovery stage, as well as the protective effect of SARS-CoV-2 vaccination against Omicron infection.@*METHODS@#A retrospective analysis was performed on 110 children who were diagnosed with coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 Omicron variant infection in Tianjin of China from January 8 to February 7, 2022. According to the status of vaccination before diagnosis, they were divided into a booster vaccination (3 doses) group with 2 children, a complete vaccination (2 doses) group with 90 children, an incomplete vaccination (1 dose) group with 5 children, and a non-vaccination group with 13 children. The clinical data and IgG level were compared among the 4 groups.@*RESULTS@#The complete vaccination group had a significantly higher age than the non-vaccination group at diagnosis (P<0.05), and there was a significant difference in the route of transmission between the two groups (P<0.05). There were no significant differences among the four groups in sex, clinical classification, and re-positive rate of SARS-CoV-2 nucleic acid detection (P>0.05). All 97 children were vaccinated with inactivated vaccine, among whom 85 children (88%) were vaccinated with BBIBP-CorV Sinopharm vaccine (Beijing Institute of Biological Products, Beijing, China). At 1 month after diagnosis, the booster vaccination group and the complete vaccination group had a significantly higher level of SARS-CoV-2 IgG antibody than the non-vaccination group (P<0.05), and at 2 months after diagnosis, the complete vaccination group had a significantly higher level of SARS-CoV-2 IgG antibody than the non-vaccination group (P<0.05). For the complete vaccination group, the level of SARS-CoV-2 IgG antibody at 2 months after diagnosis was significantly lower than that at 1 month after diagnosis (P<0.05).@*CONCLUSIONS@#Vaccination with inactivated SARS-CoV-2 vaccine has a protective effect against Omicron infection in children. For children vaccinated with 2 doses of the vaccine who experience Omicron infection, there may be a slight reduction in the level of SARS-CoV-2 IgG antibody at 2 months after diagnosis. Citation:Chinese Journal of Contemporary Pediatrics, 2022, 24(7): 736-741.
Subject(s)
Antibodies, Viral , COVID-19 , COVID-19 Vaccines , Child , Humans , Immunoglobulin G , Retrospective Studies , SARS-CoV-2 , Viral VaccinesABSTRACT
In order to construct a recombinant replication deficient human type 5 adenovirus (Ad5) expressing a foot-and-mouth disease virus (FMDV) capsid protein, specific primers for P12A and 3B3C genes of FMDV-OZK93 were synthesized. The P12A and 3B3C genes were then amplified and connected by fusion PCR, and a recombinant shuttle plasmid pDC316-mCMV-EGFP-P12A3B3C expressing the FMDV-OZK93 capsid protein precursor P12A and 3B3C protease were obtained by inserting the P12A3B3C gene into the pDC316-mCMV-EGFP plasmid. The recombinant adenovirus rAdv-P12A3B3C-OZK93 was subsequently packaged, characterized and amplified using AdMaxTM adenovirus packaging system, and the expression was verified by infecting human embryonic kidney cell HEK-293. The humoral and cellular immunity levels of well-expressed and purified recombinant adenovirus immunized mice were evaluated. The results showed that rAdv-P12A3B3C-OZK93 could be stably passaged and the maximum virus titer reached 1×109.1 TCID50/mL. Western blotting and indirect immunofluorescence showed that rAdv-P12A3B3C-OZK93 expressed the FMDV-specific proteins P12A and VP1 in HEK-293 cells. In addition, the PK cell infection experiment confirmed that rAdv-P12A3B3C-OZK93 could infect porcine cells, which is essential for vaccination in pigs. Comparing with the inactivated vaccine group, the recombinant adenovirus could induce higher FMDV-specific IgG antibodies, γ-IFN and IL-10. This indicates that the recombinant adenovirus has good immunity for animal, which is very important for the subsequent development of foot-and-mouth disease vaccine.
Subject(s)
Adenoviridae/genetics , Adenoviruses, Human/genetics , Animals , Antibodies, Viral , Capsid/metabolism , Capsid Proteins , Foot-and-Mouth Disease/prevention & control , Foot-and-Mouth Disease Virus/genetics , HEK293 Cells , Humans , Mice , Recombinant Proteins/genetics , Serogroup , Swine , Viral Proteins , Viral Vaccines/geneticsABSTRACT
In order to obtain virus-like particles (VLPs) for prevention of bovine viral diarrhea virus 1 (BVDV-1), the C-Erns-E1-E2 region was cloned into a pFastBacDaul vector for generating the recombinant Bacmid-BVDV-1 in DH10Bac Escherichia coli. The recombinant baculovirus Baculo-BVDV-1 was produced by transfecting the Sf9 cells with Bacmid-BVDV-1. The expressed protein and the assembled VLPs were determined by immunofluorescence, Western blotting and electron microscopy. Guinea pigs were immunized with inactivated VLPs coupled with the Montanide ISA-201 adjuvant. The immunogenicity of VLPs was evaluated by monitoring the humoral immune response with neutralizing antibody titer determination, as well as by analyzing the cell-mediated immune response with lymphocyte proliferation assay. The protective efficacy of VLPs was evaluated by challenging with 106 TCID50 virulent BVDV-1 strain AV69. The results showed that the recombinant Baculo-BVDV-1 efficiently expressed BVDV structural protein and form VLPs in infected Sf9 cells. The immunization of guinea pigs with VLPs resulted in a high titer (1:144) of neutralizing antibody, indicating an activated cellular immunity. Significantly lower viral RNA in the blood of the post-challenged immunized guinea pigs was observed. The successful preparation of BVDV VLPs with insect cell expression system and the observation of the associated immunogenicity may facilitate further development of a VLPs-based vaccine against BVD.
Subject(s)
Animals , Antibodies, Viral , Diarrhea , Diarrhea Virus 1, Bovine Viral , Guinea Pigs , Mineral Oil , Viral Envelope Proteins , Viral VaccinesSubject(s)
Humans , Pneumonia, Viral/prevention & control , Viral Vaccines/immunology , Coronavirus Infections/immunology , Pandemics/prevention & control , Betacoronavirus/immunology , Brazil/epidemiology , Immunization Programs/organization & administration , Epidemiological Monitoring , Health PolicyABSTRACT
En las campañas de vacunación, como en la actual situación de COVID-19, es habitual que los países señalen posibles efectos adversos después de la vacunación. Esto no significa necesariamente que los eventos estén relacionados con la vacunación en sí, pero es necesario investigarlos. También muestra que el sistema de vigilancia funciona y que existen controles efectivos. La Organización Mundial de la Salud (OMS) está en contacto regular con la Agencia Europea de Medicamentos (EMA) y otras autoridades reguladoras del mundo para obtener la información más reciente sobre la seguridad de todas las vacunas para COVID-19.
Subject(s)
Humans , Pneumonia, Viral/immunology , Viral Vaccines/adverse effects , Coronavirus Infections/immunology , Upper Extremity Deep Vein Thrombosis/chemically induced , Pandemics/prevention & control , Betacoronavirus/immunology , Drug Monitoring/adverse effects , Immunization Programs/organization & administration , EuropeABSTRACT
Há quase um ano desde o início da pandemia de COVID-19, e os cientistas de todo o mundo avançaram rapidamente no desenvolvimento de vacinas seguras e eficazes que ajudarão a reduzir doenças, hospitalizações e mortes associadas à COVID-19. Espera-se que essas vacinas contribuam consideravelmente para a proteção e a promoção equitativas do bem-estar humano e que possibilitem o retorno progressivo às atividades sociais, econômicas, profissionais e familiares. O objetivo deste documento é apoiar os países da Região das Américas no planejamento dos componentes operacionais do programa de imunizações em preparação para a vacina contra a COVID-19. Para tanto, seguem-se os princípios e valores recomendados pelo SAGE e pelo GTA bem como as recomendações técnicas da OPAS e da OMS. Essas recomendações destinam-se ao planejamento da introdução das vacinas contra a COVID-19 no nível operacional, seguindo as recomendações do roteiro do SAGE e da priorização dos grupos populacionais estabelecida pelo país. As recomendações são preliminares e serão atualizadas à medida que novas evidências forem disponibilizadas.
A casi un año del inicio de la pandemia de COVID-19, científicos de todo el mundo han avanzado rápidamente en el desarrollo de vacunas seguras y eficaces que contribuirán a reducir las enfermedades, las hospitalizaciones y las muertes asociadas a la COVID-19. Se espera que dichas vacunas ayuden significativamente a proteger y promocionar de manera equitativa el bienestar humano, y que permitan retomar de forma progresiva las actividades sociales, económicas, laborales y familiares. El propósito de este documento es apoyar a los países de la Región de las Américas a planificar los componentes operacionales del programa de inmunizaciones en preparación para la introducción de la vacuna contra la COVID-19. Para ello se siguen los principios y los valores recomendados por el Grupo de Expertos de la Organización Mundial de la Salud (OMS) en Asesoramiento Estratégico sobre Inmunización y el Grupo Técnico Asesor sobre enfermedades prevenibles por vacunación de la Organización Panamericana de la Salud (OPS), así como las recomendaciones técnicas de la OPS y la OMS. El documento contiene recomendaciones relativas a la microplanificación de la introducción de las vacunas y a la priorización de los grupos poblacionales. Las recomendaciones son preliminares y se actualizarán a medida que se disponga de nueva evidencia.
Almost a year into the COVID-19 pandemic, scientists throughout the world have swiftly moved to develop safe and effective vaccines that will help reduce illness, hospitalizations, and deaths associated with COVID-19. These vaccines are expected to make a significant contribution to equitable protection and promotion of human well-being and a gradual return to social, economic, work, and family life. This manual is designed to assist the countries of the Region of the Americas in planning the operational components of the immunization program to ready them for the COVID-19 vaccine. To accomplish this, it follows the principles and values recommended by SAGE and the TAG, as well as the technical recommendations of PAHO and WHO. The aim of these recommendations is to plan for the introduction of COVID-19 vaccines at the operational level and country prioritization of population groups. The recommendations are preliminary and will be updated as new evidence becomes available.
Près d'un an après le début de la pandémie de COVID-19, les scientifiques du monde entier ont réalisé des avancées rapides dans la mise au point de vaccins sûrs et efficaces qui contribueront à réduire les maladies, les hospitalisations et les décès associés à la COVID19. Ces vaccins devraient contribuer de manière significative à la protection et à la promotion équitables du bien-être humain, et permettre un retour progressif aux activités sociales, économiques, professionnelles et familiales. Le présent document a pour objet d'aider les pays de la Région des Amériques à planifier les composantes opérationnelles du programme de vaccination en vue des préparatifs concernant le vaccin contre la COVID-19. Il suit les principes et les valeurs recommandés par le SAGE et le GCT, ainsi que les recommandations techniques de l'OPS et de l'OMS. Ces recommandations visent à planifier l'introduction des vaccins contre la COVID-19 au niveau opérationnel et la détermination des groupes de population à vacciner en priorité. Les recommandations sont préliminaires et seront mises à jour à mesure que de nouveaux éléments probants seront disponibles.
Subject(s)
Humans , Pneumonia, Viral/prevention & control , Viral Vaccines/immunology , Immunization Programs/organization & administration , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Betacoronavirus/immunology , Health PrioritiesABSTRACT
El propósito de esta guía es brindar orientación sobre 1) la elaboración y actualización del plan nacional de despliegue y vacunación para las vacunas contra la COVID19; 2) el diseño de estrategias para el despliegue, la imeplementación y el seguimiento; y 3) la armonización del plan y el financiamiento con los demás planes nacionales de recuperación, respuesta y apoyo frente a la COVID-19. Está dirigida a las autoridades nacionales responsables de gestionar el despliegue, la implementación y el seguimiento de las vacunas contra la COVID19, así como a los asociados encargados de prestar el apoyo necesario.
Subject(s)
Humans , Pneumonia, Viral/prevention & control , Viral Vaccines/immunology , Immunization Programs/organization & administration , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Betacoronavirus/immunologyABSTRACT
Todos os países do mundo formularam planos de resposta para enfrentar a pandemia da COVID-19. No entanto, os desafios impostos pela doença os obrigam a aprender e adaptar-se constantemente. Cada vez mais é necessário reforçar o componente de comunicação de riscos como uma ferramenta essencial para transmitir à população, da devida forma, todas as informações sobre o processo de imunização, desde os testes clínicos e a produção de novas vacinas, até a adoção, distribuição e priorização dos grupos aos quais serão administradas uma ou mais vacinas dependendo da definição e disponibilidade de cada país , bem como sobre o acesso universal às vacinas, após os grupos prioritários terem sido imunizados. A Organização Pan-Americana da Saúde, em seu esforço constante e permanente para apoiar os países das Américas, apresenta este documento para facilitar a formulação de uma estratégia de comunicação de riscos e participação comunitária (CRPC) para a vacinação contra o SARS-CoV-2. O intuito é contribuir para o fortalecimento das capacidades de comunicação e planejamento dos ministérios e secretarias de saúde, bem como de outros órgãos responsáveis pela comunicação na área das novas vacinas contra a COVID-19 nas Américas.
Todos los países del mundo han desarrollado planes de respuesta para enfrentar la pandemia de COVID-19; sin embargo, los desafíos que presenta la enfermedad los obliga a un aprendizaje y a una adaptación constantes. Cada vez es más necesario reforzar el componente de comunicación de riesgos como herramienta esencial para transmitir de forma adecuada a la población toda la información sobre el proceso de inmunización, desde los ensayos clínicos y la producción de nuevas vacunas, hasta la introducción, distribución y priorización de grupos a los que hay que administrar una o varias vacunas según la definición y la disponibilidad de cada país así como el acceso universal a ellas, una vez inmunizados los grupos prioritarios. La OPS, dentro de su empeño constante por apoyar a los países de las Américas, publica el presente documento con ánimo de facilitar la elaboración de una estrategia de comunicación de riesgos y participación comunitaria para la vacunación contra la COVID-19. Su finalidad es contribuir a fortalecer las capacidades y la planificación de la comunicación de los ministerios o secretarías de salud, así como de otros organismos encargados de comunicar en el área de las nuevas vacunas contra la COVID-19 en las Américas.
All countries around the world have developed response plans to tackle the COVID-19 pandemic. However, the challenges presented by the disease require constant learning and adaptation. It is increasingly necessary to strengthen the risk communication component as an essential tool for providing the population with all of the necessary information about the immunization process. This ranges from clinical trials and the production of new vaccines to the introduction, distribution, and prioritization of groups that need one or more vaccinesaccording to each country's definitions and vaccine availability. It also includes universal access to vaccines, once the priority groups have been immunized. PAHO, in its constant, ongoing effort to support the countries of the Americas, is making this document available to facilitate the preparation of a risk communication and community engagement strategy for vaccination against COVID-19. Its goal is to help to strengthen the communication and planning capacities of the ministries or secretariats of health and other agencies in charge of communicating about new COVID-19 vaccines in the Americas.
Subject(s)
Humans , Pneumonia, Viral/immunology , Viral Vaccines/immunology , Immunization Programs/organization & administration , Coronavirus Infections/immunology , Health Communication , Pandemics/prevention & control , Betacoronavirus/immunologyABSTRACT
Las vacunas seguras y efectivas contra la COVID-19 son una herramienta valiosa para manejar la pandemia de COVID-19. La ejecución de actividades de comunicación y participación de la comunidad para apoyar el despliegue de las vacunas contra la COVID-19 será una tarea esencial, compleja y desafiante para los ministerios de salud y sus asociados. Las actividades de comunicación y participación de la comunidad deben comenzar de inmediato para manejar las expectativas, en particular en torno al suministro y la disponibilidad de vacunas en las primeras fases del despliegue y la preparación del público para la introducción.
Subject(s)
Humans , Pneumonia, Viral/prevention & control , Viral Vaccines/immunology , Immunization Programs/organization & administration , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Betacoronavirus/immunologyABSTRACT
El propósito de estas orientaciones es apoyar el desarrollo de un sistema regional de vigilancia de ESAVI y AESI sensible, oportuno, estandarizado, confiable e integrado, con la participación de todos los actores involucrados en la vacunación segura, con vistas a mantener la confianza en la vacunación y la aceptación de la inmunización en las Américas. El sistema contribuirá a la detección temprana y a la clasificación adecuada de los ESAVI graves y de las señales de riesgo, para generar una respuesta rápida y apropiada a nivel nacional y regional.
The purpose of tthis guidance document is to develop a sensitive, timely, standardized, reliable, and integrated regional AEFI surveillance system with the participation of all actors involved in safe vaccination to maintain trust in vaccination and acceptance of immunization in the Americas. Contribute to the early detection and correct classification of serious AEFIs and risk markers to generate a rapid and appropriate national and regional response.
Subject(s)
Humans , Pneumonia, Viral/immunology , Viral Vaccines/immunology , Immunization Programs/organization & administration , Coronavirus Infections/immunology , Pandemics/prevention & control , Betacoronavirus/immunologyABSTRACT
Para facilitar la introducción de la vacuna contra la COVID-19 el Ministerio de Salud Pblica y Asistencia Social (MSPAS) estableció el Comité Nacional de Coordinación para Vacunación contra COVID-19 (CNVCOVID) a través del Acuerdo Ministerial No 0262-2020, con la finalidad de desarrollar e implementar el plan estratégico nacional de vacunación contra la COVID-19. Este documento representa ese producto, en el cual se integran y describen los componentes esenciales para el despliegue de la vacunación contra la COVID-19 el cual se actualizará periódicamente, a medida que se obtenga información actualizada, científica, legal y técnico-operativa para fortalecer la estrategia de vacunación contra la COVID-19 en Guatemala