ABSTRACT
A single dose of standard yellow fever (YF) vaccine is considered to provide life-long protection. In this study, we evaluate the seropositivity conferred by lower doses 10 years post-vaccination. In 2009, Bio-Manguinhos/Fiocruz performed a dose-response study with the 17DD yellow fever vaccine, administering the vaccine in the usual mean dose of 27.476 IU and in decreasing doses (10.447 IU, 3.013 IU, 587 IU, 158 IU and 31 IU), with the usual volume and route (0,5 ml subcutaneous). The decreasing doses were obtained by dilution in the laboratory of the manufacturer and the lots in test had standard quality control and were produced by good manufacturing practices (GMP). Around 30 days after the vaccination, doses down to 587 IU had similar immunogenicity and the 158 IU and 31 IU were inferior to the full dose. The seropositivity was maintained for 10 months, except on the 31 IU group. Eight years after, 85 % of 318 participants evaluated in a follow-up, maintained seropositivity that was similar across groups. Consistently, antibody titers in the reduced-dose groups were also comparable to those of the full-dose group. The current study, 10 years later, showed similarity between the vaccine groups (six arms who received the YF vaccine in decreasing doses: 27.476 IU, 10.447 IU, 3.013 IU, 587 IU, 158 IU, 31 IU) both in relation of seropositivity and in the evaluation of the geometric mean titers. The seropositivity rates across subgroups were 83,1%, 90 %, 87 %, 93 %, 83,8% and 85 %, correspondingly. These findings provides further support to the long-term immunogenicity of lower doses. Clinical trial registry: NCT04416477.
ABSTRACT
O interesse da presente Dissertação surgiu com o intuito de avaliar as Unidades de Terapia Intensiva Pediátricas no aspecto de estrutura do serviço. O inquérito do estudo foi colhido de 01/07/2020 a 31/10/2020 através de um questionário autopreenchido pelos 29 médicos responsáveis técnicos e pelos 1084 profissionais de saúde atuantes nas unidades. O objetivo primário da Dissertação foi avaliar a adequabilidade de aspectos estruturais de 29 Unidades de Terapia Intensiva Pediátricas de sete estados no Brasil à regulamentação normativa que já estava vigente no país antes da pandemia, e às normativas e demandas impostas durante a pandemia. Foram analisados seletos indicadores de estrutura (recursos humanos, protocolos, estrutura física, orientações e rotinas na pandemia, educação continuada e treinamento, e recursos materiais). Na análise de indicadores para verificação de adequação à normativa regulamentadora, avaliou-se que na dimensão de recursos humanos e protocolos ao menos um terço das unidades não cumpriam requisitos previstos em norma. Em recursos humanos, as menores proporções observadas foram para a categoria de técnicos de enfermagem, médicos diaristas e fisioterapeutas (65.5%, 69.1%, 82.7%). Para protocolos clínicos, há 55.2% de unidades que têm protocolos de sepse, sedação e dor instalados e vigentes. Apesar de já haver essa defasagem em questões estruturais, quando se analisou a adequação para as normativas e demandas da pandemia, verificou-se que a resposta das unidades nas diferentes dimensões de estrutura analisadas foi em geral melhor ou semelhante ao observado em estudos feitos na mesma época na América Latina. Foram entrevistados 1084 profissionais de saúde e 60% tiveram disponibilidade de Equipamentos de Proteção Individual (EPI) para assistência em procedimentos geradores de aerossol. As unidades com financiamento privado obtiveram maiores proporções de adequação em recursos humanos para algumas categorias profissionais durante a pandemia como para médicos intensivistas (44.8% x 17.2%; p<0.01). Também houve diferença significativa em recursos materiais, como para assistência em procedimentos geradores de aerossol (31.3% x 28.8%; p=0.02). A categoria profissional que teve mais inadequação à normativa para disponibilidade de EPI foi a de técnicos de enfermagem (14.4% x 11.3%; p<0.01). O que se observou, portanto, foi que nos aspectos avaliados a situação pré-pandemia era razoável, mas já com espaços para melhorias, e durante a crise sanitária houve uma resposta comparável a resultados encontrados em outros estudos na região. Porém, se tivesse havido uma gestão mais eficiente com deslocamento adequado de recursos, é provável que a reação tivesse sido melhor. (AU)
The interest of this dissertation arose to evaluate Pediatric Intensive Care Units (PICU) in terms of service structure. The study survey was collected from 07/01/2020 to 10/31/2020 through a self-completed questionnaire by the 29 technical responsible physicians and 1084 health professionals working in the unit. The primary objective was to describe and evaluate the suitability of structural aspects of 29 Pediatric Intensive Care Units from seven states in Brazil to the normative regulation that was already in course in Brazil before the pandemic, and to the norms and demands imposed during the pandemic. It is proposed to analyze structure indicators (human resources, protocols, physical structure, guidelines and routines in the pandemic, continuing education and training, and material resources). In the analysis of indicators for verification of adequacy to the regulatory norms, it was evaluated that in the dimension of human resources and protocols, at least one third of the units did not fulfill requirements foressen in the norm. In human resources, the lowest proportions observed were for the category of nursing technicians, diarist doctors and physiotherapists (65.5%, 69.1%, 82.7%). For protocols and routines, there are 55.2% of units that have sepsis sedation and pain protocols installed and current. Despite this lag, already existing, when the suitability for the pandemic's regulations and demands was analyzed, it was found that the response of the units in the different structural dimensions analyzed was generally better or similar to that observed in studies carried out at that period in Latin America. There were 1084 health professionals interviewed and 60% had personal protective Equipment (PPE) available for assistance in aerosol- generating procedures. Units with private funding had higher proportions of adequacy in human resources for some professional categories during the pandemic such as intensive care physicians (44.8% x 17.2%; p<0.01), and material resources, such as assistance in aerosol-generating procedures (31.3% x 28.8%; p=0.02). The professional category that had the most inadequacy to the regulations for the availability for of PPE (personal protective equipment) was that of nursing technicians (14.4% x 11.3%; p<0.01). What was observed, therefore, was that in the aspects evaluated, the pre-pandemic situation was reasonable, but already with room for improvement, and during the health crisis there was a response comparable to results found in other studies in the region. However, if there had been more efficient management with adequate allocation of resources, it is likely that the reaction would have been better. (AU)