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Background: Vaccination is an extremely safe public health intervention, but rare IgE-mediated adverse events must be identified to avoid the risk of anaphylaxis in the event of reexposure. However, using only clinical history to diagnose previous allergic reactions may lead to overdiagnosis of vaccine allergy and even to the use of medical exemptions as a subterfuge to mandatory vaccination. Methods: We conducted a retrospective study to describe the outcomes of patients with a history of vaccine or vaccine component allergy who were evaluated at our unit from 2011 to 2017. Data on allergy history, skin test results, vaccines prescribed, and adverse events were retrieved from the medical records at the Centro de Referência para Imunobiológicos Especiais (Reference Center of Special Immunobiologicals)–Fiocruz, in Rio de Janeiro, Brazil. Results: Of 34 adults with history of allergy to vaccine or vaccine components, 32 (94.1%) were successfully vaccinated without serious adverse events after our evaluation. In 12 patients (35%), the time elapsed between the allergy symptoms and evaluation in the Centro de Referência para Imunobiológicos Especiais–Fiocruz was more than 10 years. Conclusion: Specialized care and use of skin tests allowed safe vaccination of the majority of patients. An objective, systematic evaluation of a history of vaccine allergy can prevent its improper use to avoid mandatory vaccination and reduce missed opportunities for immunization.

Monitoring of clinical trials is critical to the protection of human subjects and the conduct of high-quality research. Even though the adoption of risk-based monitoring (RBM) has been suggested for many years, the RBM approach has been less widespread than expected. Centralized monitoring is one of the RMB pillars, together with remote-site monitoring visits, reduced Source Data Verification (SDV) and Source Document Reviews (SDR). The COVID-19 pandemic promoted disruptions in the conduction of clinical trials, as on-site monitoring visits were adjourned. In this context, the transition to RBM by all actors involved in clinical trials has been encouraged. In order to ensure the highest quality of data within a COVID-19 clinical trial, a centralized monitoring tool alongside Case Report Forms (CRFs) and synchronous automated routines were developed at the clinical research platform, Fiocruz, Brazilian Ministry of Health. This paper describes how these tools were developed, their features, advantages, and limitations. The software codes, and the CRFs are available at the Fiocruz Data Repository for Research-Arca Dados, reaffirming Fiocruz's commitment to Open Science practices.

En los últimos años la República Dominicana ha experimentado una importante reducción en las coberturas de vacunación, producto de esta situación son los casos de tétanos y difteria que han surgido recientemente. Con el objetivo de identificar las barreras para la inmunización y determinar el impacto de la COVID-19 en la adherencia a la vacunación, 2.584 dominicanos completaron una encuesta en línea sobre el historial de vacunación personal y las razones para no vacunarse. Además, respondieron preguntas sobre la aceptación de la vacuna contra la COVID-19 y la influencia de la pandemia en su percepción/adherencia a la vacunación. La mayoría de los encuestados no se vacunó durante la pandemia, el principal motivo fue: “no tenía ninguna vacuna programada para este año”. Lo que indica que a pesar de que la pandemia dificultó el acceso a los servicios de vacunación, esta no fue la principal barrera para la inmunización en República Dominicana en el 2020. A pesar de que la mayoría de los participantes están a favor de la vacunación, de las vacunas incluidas en nuestro estudio, la vacuna contra sarampión, rubéola y parotiditis (en niños) fue la única que alcanzó el objetivo del Plan de Acción Mundial sobre Vacunas, de lograr una cobertura de vacunación del 90% para el 2020. La principal barrera para la inmunización es el olvido de vacunarse. Es necesario adoptar un sistema de recordatorio eficaz para aumentar la adherencia y mejorar las tasas de inmunización.

BackgroundA vaccination campaign targeted adults in response to the pandemic in the City of Rio de Janeiro.ObjectiveWe aimed to evaluate the seroprevalence of SARS-CoV-2 antibodies and identify factors associated with seropositivity on vaccinated and unvaccinated residents.MethodsWe performed a seroepidemiologic survey in all residents of Paquetá Island, a neighborhood of Rio de Janeiro city, during the COVID-19 vaccine roll-out. Serological tests were performed from June 16 to June 19, 2021, and adjusted seropositivity rates were estimated by age and epidemiological variables. Logistic regression models were used to estimate adjusted ORs for risk factors to SARS-CoV-2 seropositivity in non-vaccinated individuals, and potential determinants of the magnitude of antibody responses in the seropositive population.ResultsWe included in the study 3,016 residents of Paquetá (83.5% of the island population). The crude seroprevalence of COVID-19 antibodies in our sample was 53.6% (95% CI = 51.0, 56.3). The risk factors for SARS-CoV-2 seropositivity in non-vaccinated individuals were history of confirmed previous COVID-19 infection (OR = 4.74; 95% CI = 3.3, 7.0), being a household contact of a case (OR = 1.93; 95% CI = 1.5, 2.6) and in-person learning (OR = 2.01; 95% CI = 1.4, 3.0). Potential determinants of the magnitude of antibody responses among the seropositive were hybrid immunity, the type of vaccine received, and time since the last vaccine dose. Being vaccinated with Pfizer or AstraZeneca (Beta = 2.2; 95% CI = 1.8, 2.6) determined higher antibody titers than those observed with CoronaVac (Beta = 1.2; 95% CI = 0.9, 1.5).ConclusionsOur study highlights the impact of vaccination on COVID-19 collective immunity even in a highly affected population, showing the difference in antibody titers achieved with different vaccines and how they wane with time, reinforcing how these factors should be considered when estimating effectiveness of a vaccination program at any given time. We also found that hybrid immunity was superior to both infection-induced and vaccine-induced immunity alone, and online learning protected students from COVID-19 exposure.

The coronavirus disease 2019 pandemic abruptly changed the dynamics of basic health care, with the consequent need for adjustments in essential services. The objective of this study was to evaluate the acceptance and impact of telemedicine at a Reference Center for Special Immunobiologicals (CRIE). Methods: Patients aged 18 years or older who had a medical referral to CRIE and agreed to have a telemedicine consultation were included. After the medical appointments, participants answered a satisfaction survey. Results: From April 2021 to February 2022, 702 telemedicine consultation were conducted. Over 3,380 vaccines were prescribed via telemedicine. Of all the participants who answered the satisfaction questionnaire, 99.8% stated that they would recommend the service to other people. Conclusions: Telemedicine proved to be promising tool for healthcare at CRIE and had good acceptance by users, potentially improving access and extending the reach of the National Immunization Program.

Introducción: la especialidad Medicina del Viajero existe hace más de 40 años. Sin embargo, esta es prácticamente desconocida por los dominicanos a pesar de la gran cantidad de personas que viajan desde y hacia nuestro país. Material y métodos: Con el objetivo de determinar el conocimiento de los dominicanos sobre la existencia de la Medicina del Viajero y sus actitudes en relación a esta, realizamos una encuesta virtual de 8 preguntas, de la cual participaron 2,584 dominicanos. Resultados: a pesar de que más del 80 % de los encuestados sabían que para viajar a determinados países debían tomar ciertas vacunas, menos del 25 % había escuchado hablar de la especialidad Medicina del Viajero. Tras conocer la definición y objetivos de la especialidad más del 90 % de los participantes consideró importante realizar una consulta previa al viaje con un especialista. Conclusión: el desconocimiento de la especialidad y la ausencia de este servicio en el sistema público de salud son las principales barreras para el acceso de los dominicanos a la consulta de Medicina del Viajero. Es necesario dar a conocer la especialidad, utilizando evidencia científica y tomando como ejemplo la difusión mundial de la COVID-19 a través de los viajeros, concienciar a la población de la importancia de la consulta pre y post viaje, así como la creación de este servicio en hospitales públicos.

A pandemia causada pelo SARS-CoV-2 mudou de forma abrupta toda a dinâmica da assistência básica de saúde, havendo a necessidade de adaptações dos serviços considerados essenciais. O objetivo desse trabalho é avaliar a aplicabilidade e o impacto da telemedicina em um Centro de Referência para Imunobiológicos Especiais (CRIE). Métodos Foram incluídos pacientes com 18 anos ou mais de idade que, após leitura e assinatura do TCLE eletrônico, completaram formulário de solicitação de consulta online com o upload do encaminhamento para o CRIE. Após avaliação de elegibilidade, a confirmação do agendamento é enviada por e-mail com o link e orientações para o acesso à consulta virtual. A consulta entre médico e paciente acontece com hora marcada em uma sala virtual privada por meio da Rede Universitária de Telemedicina (RUTE). As fichas para registro das informações foram construídas utilizando o REDCap. Resultados De abril a setembro/2021, foram atendidos 410 pacientes por telemedicina, sendo 90% para programação vacinal, 4,4% eventos adversos pós-vacinais, 5,1% para orientações e 0,5% para interconsulta entre profissionais de saúde. A idade média dos pacientes foi de 54,8 anos, 63,2% eram do sexo feminino, 31% tinham nível superior ou mais de escolaridade, 29,9% residiam fora do Município do RJ. As indicações mais frequentes para o encaminhamento ao CRIE foram: nefropatia crônica (n 75), pneumopatia (n 69), doença autoimune (n 43), cardiopatia (n 40) e diabetes mellitus (n 35). Foram prescritas por mais de 1.700 vacinas por este canal, sendo as mais frequentes: pneumo 23 (n 344), pneumo 13 (n 328), dT (231) e meningo C (197). Do total dos participantes que responderam ao questionário de satisfação (n 319), 99,7% dos participantes recomendariam o serviço para outras pessoas. Conclusões O CRIE é a unidade do Programa Nacional de Imunização que atende indivíduos que necessitam receber imunobiológicos especiais. A centralização do atendimento no CRIE permite um maior controle do uso desses imunobiológicos que, em geral, são de maior custo e/ou menor disponibilidade no mercado; entretanto dificulta o acesso da população às vacinas especiais. Nos primeiros meses da pandemia pelo SARS-CoV-2, houve uma redução significativa do número de atendimentos no CRIE. A telemedicina se mostrou uma ferramenta útil para o atendimento no CRIE e com boa aceitação pelos usuários, com potencial de facilitar o acesso e aumentar o alcance do atendimento do CRIE.

Introdução: Nos últimos anos a América Latina tem experimentado uma redução importante das coberturas vacinais. Desde 2017, os surtos de febre amarela, sarampo e difteria que tem acontecido em diferentes países da região são consequências desta situação. Métodos: Com o objetivo de determinar as barreiras para a imunização, o impacto da pandemia na percepção da vacinação e a aceitação da vacina contra a COVID-19, realizamos um estudo tranversal online que incluiu 9.487 participantes de 9 países da América Latina (Argentina, Brasil, Colômbia, República Dominicana, Equador, Honduras, México, Panamá e Peru). Todos os participantes responderam um questionario sobre seu histórico de imunização/motivos de não ter tomado as vacinas contra sarampo-caxumba-rubéola (MMR) e tétano-difteria (dT). Pessoas com doenças crônicas também responderam sobre a vacina contra Influenza; profissionais de saúde responderam sobre vacinas contra Hepatite B e Influenza. Pais de crianças menores de 15 anos responderam sobre a situação vacinal de seus filhos para o calendário completo, com destaque para vacinas contra Papilomavírus Humano (HPV), MMR e Influenza. Também foram respondidas perguntas sobre a influência da pandemia na percepção da vacinação e a aceitação da vacina contra a COVID-19. Resultados: A principal barreira para a imunização contra sarampo-caxumba-rubéola e tétano-difteria, assim como contra Influenza para profissionais de saúde, foi o esquecimento da vacinação. Já para vacinas do calendário infantil, como HPV e MMR, e contra Influenza em adultos com doenças crônicas, o principal motivo foi o medo de eventos adversos. A pandemia teve impacto positivo em relação à mudança na percepção da vacinação para 12% dos participantes, o principal motivo dessa mudança foi “alguém próximo teve COVID-19 grave ou morreu devido a esta doença”. Mais de 80% dos participantes estavam dispostos a tomar a vacina contra a COVID-19. Conclusão: Duas barreiras importantes para a imunização na América Latina são o esquecimento de vacinar-se e o medo de eventos adversos. Para reduzir a baixa adesão e melhorar as taxas de imunização é necessário adotar um sistema de lembrete eficaz e educar a população em relação à vacinação. Apesar da queda das coberturas vacinais nos últimos anos a grande maioria dos latino-americanos são a favor da vacinação e estão dispostos a tomar a vacina contra a COVID-19.

Introdução: A Medicina de Viagem existe há mais de 40 anos. A prática desta especialidade no Brasil começou em 1997 na cidade do Rio de Janeiro. No entanto, essa especialidade é praticamente desconhecida no Brasil, apesar do grande número de brasileiros que viajam anualmente dentro e fora do país. Métodos: Com o objetivo de determinar o conhecimento dos brasileiros sobre a existência da Medicina de Viagem e suas atitudes em relação a ela, realizamos uma enquete online com 10 questões, da qual participaram 3.237 brasileiros. Resultados: Apesar de mais de 95% dos participantes saberem que para viajar a determinados países precisam tomar certas vacinas, apenas 28% dos participantes já ouviu falar em Medicina de Viagem, dos quais 30% tinha realizado uma consulta com um especialista antes de viajar. Depois de conhecer a definição e os objetivos da especialidade, mais de 90% considerou importante realizar uma consulta pré-viagem. Conclusão: A falta de conhecimento é a principal barreira para o acesso dos brasileiros à consulta de Medicina de Viagem. É necessário divulgar a especialidade, utilizando evidências científicas e tendo como exemplo a difusão mundial da COVID-19 por meio dos viajantes, conscientizar a população sobre a importância da consulta pré e pós-viagem.

BackgroundCentral nervous system infections (CNSI) are diseases with high morbidity and mortality, and their diagnosis in the intensive care environment can be challenging. Objective: To develop and validate a diagnostic model to quickly screen intensive care patients with suspected CNSI using readily available clinical data.MethodsDerivation cohort: 783 patients admitted to an infectious diseases intensive care unit (ICU) in Oswaldo Cruz Foundation, Rio de Janeiro RJ, Brazil, for any reason, between 01/01/2012 and 06/30/2019, with a prevalence of 97 (12.4%) CNSI cases. Validation cohort 1: 163 patients prospectively collected, between 07/01/2019 and 07/01/2020, from the same ICU, with 15 (9.2%) CNSI cases. Validation cohort 2: 7,270 patients with 88 CNSI (1.21%) admitted to a neuro ICU in Chicago, IL, USA between 01/01/2014 and 06/30/2019. Prediction model: Multivariate logistic regression analysis was performed to construct the model, and Receiver Operating Characteristic (ROC) curve analysis was used for model validation. Eight predictors-age 2 cells/mm3, fever (≥38°C/100.4°F), focal neurologic deficit, Glasgow Coma Scale ResultsThe pool data's model had an Area Under the Receiver Operating Characteristics (AUC) curve of 0.892 (95% confidence interval 0.864-0.921, PConclusionsA promising and straightforward screening tool for central nervous system infections, with few and readily available clinical variables, was developed and had good accuracy, with internal and external validity.

Abstract: Varicella in adults and immunocompromised patients can be severe. The clinical diagnosis of varicella has high accuracy and the history of disease has a high positive predictive value for protection. A significant portion of adults, however, cannot remember if they have had varicella, especially older individuals. We conducted a cross-sectional study to determine the seroprevalence of varicella protective antibodies titers in adults with no clinical history of disease, attended at a Reference Center for Special Immunobiologicals and Travel Medicine in Rio de Janeiro (Brazil). Titration of immunoglobulin G (IgG) antibodies to varicella-zoster was determined by chemiluminescence immunoassay. Among 140 adults without history of varicella, 92% had protective antibody titers. We concluded that seroprevalence of varicella-zoster protection was very high in adults with negative history of disease and the use of serology before vaccination reduced significantly unnecessary vaccine and immunoglobulin use.

Abstract Background Chagas disease control programmes have decreased the prevalence of Chagas disease in Latin America. Together with migration to urban areas and increase in life expectancy, a new scenario for Chagas disease has emerged in Brazil with most patients currently elderly individuals living in urban areas. However, acute Chagas disease cases still occur due to vector transmission by sylvatic vectors and oral transmission by contaminated food. Therefore, we characterized the clinical and epidemiological profile of the patients followed at Evandro Chagas National Institute of Infectious Diseases in Rio de Janeiro, Brazil. We aimed to identify the clinical forms, associated co-morbidities, and geographical areas where younger patients originate from. This will aid in the identification of potential challenges to be currently faced. Results This is a cross-sectional study. Adult patients with chronic Chagas disease were recruited between March 2013 and April 2016. Clinical and epidemiological data were obtained from electronic medical records and interviews. The clinical form of the Chagas disease presented by the patients was determined following the Brazilian Consensus on Chagas disease. Six hundred and nineteen patients (mean age 60 ± 12 years; 56.9% women) were included in this study. Patients’ clinical forms were classified as follows: indeterminate 29.1%; cardiac 55.4%; digestive 5.5%; and mixed 10.0%. Patients aged over 65 years comprised 38% of the population. Hypertension was present in 347 (56%) patients, dyslipidemia in 261 patients (42%) and diabetes mellitus in 185 patients (30%). There were no differences regarding gender, race, comorbidities frequency or place of origin across Chagas disease clinical forms. Most of the elderly population originated from Bahia, Minas Gerais and Pernambuco states, while most of the younger patients were born in Ceará, Paraíba and Rio de Janeiro states. Conclusions We described a great proportion of elderly patients in the composition of an urban Brazilian Chagas disease patient cohort with a high prevalence of comorbidities. We also identified a change in the pattern of the place of origin among younger patients.

Abstract INTRODUCTION: Travel medicine is aimed at promoting health risk reduction. However, travelers’ perception of risk is subjective and may influence implementation of recommendations. This study reports on travelers’ perception of risk, pre-travel characteristics, and recommended interventions. METHODS: This is a descriptive cross-sectional study. RESULTS: This study included 111 individuals. Most travelers (74%) perceived their risk as low. Significant differences in travel-related risk perception between practitioners and travelers were observed (Gwet’s agreement coefficient [AC1] 0.23; standard error 0.10; 95% confidence interval 0.02-0.44). CONCLUSIONS: Future studies should investigate the relationship between travelers’ perception of risk and implementation of recommendations.

Monitoring of clinical trials is critical to the protection of human subjects and the conduct of high-quality research. Even though the adoption of risk-based monitoring (RBM) has been suggested for many years, the RBM approach has been less widespread than expected. Centralized monitoring is one of the RMB pillars, together with remote-site monitoring visits, reduced Source Data Verification (SDV) and Source Document Reviews (SDR). The COVID-19 pandemic promoted disruptions in the conduction of clinical trials, as on-site monitoring visits were adjourned. In this context, the transition to RBM by all actors involved in clinical trials has been encouraged. In order to ensure the highest quality of data within a COVID-19 clinical trial, a centralized monitoring tool alongside Case Report Forms (CRFs) and synchronous automated routines were developed at the clinical research platform, Fiocruz, Brazilian Ministry of Health. This paper describes how these tools were developed, their features, advantages, and limitations. The software codes, and the CRFs are available at the Fiocruz Data Repository for Research—Arca Dados, reaffirming Fiocruz's commitment to Open Science practices. [ABSTRACT FROM AUTHOR]

Background: Central nervous system infections (CNSI) are diseases with high morbidity and mortality, and their diagnosis in the intensive care environment can be challenging. Objective: To develop and validate a diagnostic model to quickly screen intensive care patients with suspected CNSI using readily available clinical data. Methods: Derivation cohort: 783 patients admitted to an infectious diseases intensive care unit (ICU) in Oswaldo Cruz Foundation, Rio de Janeiro RJ, Brazil, for any reason, between 01/01/2012 and 06/30/2019, with a prevalence of 97 (12.4%) CNSI cases. Validation cohort 1: 163 patients prospectively collected, between 07/01/2019 and 07/01/2020, from the same ICU, with 15 (9.2%) CNSI cases. Validation cohort 2: 7,270 patients with 88 CNSI (1.21%) admitted to a neuro ICU in Chicago, IL, USA between 01/01/2014 and 06/30/2019. Prediction model: Multivariate logistic regression analysis was performed to construct the model, and Receiver Operating Characteristic (ROC) curve analysis was used for model validation. Eight predictors—age <56 years old, cerebrospinal fluid white blood cell count >2 cells/mm3, fever (≥38°C/100.4°F), focal neurologic deficit, Glasgow Coma Scale <14 points, AIDS/HIV, and seizure—were included in the development diagnostic model (P<0.05). Results: The pool data's model had an Area Under the Receiver Operating Characteristics (AUC) curve of 0.892 (95% confidence interval 0.864–0.921, P<0.0001). Conclusions: A promising and straightforward screening tool for central nervous system infections, with few and readily available clinical variables, was developed and had good accuracy, with internal and external validity. [ABSTRACT FROM AUTHOR]

Background: Chagas disease control programmes have decreased the prevalence of Chagas disease in Latin America. Together with migration to urban areas and increase in life expectancy, a new scenario for Chagas disease has emerged in Brazil with most patients currently elderly individuals living in urban areas. However, acute Chagas disease cases still occur due to vector transmission by sylvatic vectors and oral transmission by contaminated food. Therefore, we characterized the clinical and epidemiological profile of the patients followed at Evandro Chagas National Institute of Infectious Diseases in Rio de Janeiro, Brazil. We aimed to identify the clinical forms, associated co-morbidities, and geographical areas where younger patients originate from. This will aid in the identification of potential challenges to be currently faced. Results: This is a cross-sectional study. Adult patients with chronic Chagas disease were recruited between March 2013 and April 2016. Clinical and epidemiological data were obtained from electronic medical records and interviews. The clinical form of the Chagas disease presented by the patients was determined following the Brazilian Consensus on Chagas disease. Six hundred and nineteen patients (mean age 60 ± 12 years; 56.9% women) were included in this study. Patients' clinical forms were classified as follows: indeterminate 29.1%; cardiac 55.4%; digestive 5.5%; and mixed 10.0%. Patients aged over 65 years comprised 38% of the population. Hypertension was present in 347 (56%) patients, dyslipidemia in 261 patients (42%) and diabetes mellitus in 185 patients (30%). There were no differences regarding gender, race, comorbidities frequency or place of origin across Chagas disease clinical forms. Most of the elderly population originated from Bahia, Minas Gerais and Pernambuco states, while most of the younger patients were born in Ceará, Paraíba and Rio de Janeiro states. Conclusions: We described a great proportion of elderly patients in the composition of an urban Brazilian Chagas disease patient cohort with a high prevalence of comorbidities. We also identified a change in the pattern of the place of origin among younger patients. [ABSTRACT FROM AUTHOR]