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Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development.

ABSTRACT: Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.

SUBMITTER: Roberts CC

PROVIDER: S-EPMC6816404 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development.

Roberts Christine C CC

Human vaccines & immunotherapeutics 20190716 10

Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to trac ...[more]

PMID: 31268394

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Project description:Vaccines are considered one of the greatest advances in modern medicine. The global burden of numerous infectious diseases has been significantly reduced, and in some cases, effectively eradicated through the deployment of specific vaccines. However, efforts to develop effective new vaccines against infectious pathogens such as influenza, Human immunodeficiency virus (HIV), dengue virus (DENV), chikungunya virus (CHIKV), Ebola virus, and Zika virus (ZIKV) have proven challenging. Zika virus is a mosquito-vectored flavivirus responsible for periodic outbreaks of disease in Africa, Southeast Asia, and the Pacific Islands dating back over 50 years. Over this period, ZIKV infections were subclinical in most infected individuals and resulted in mild cases of fever, arthralgia, and rash in others. Concerns about ZIKV changed over the past two years, however, as outbreaks in Brazil, Central American countries, and Caribbean islands revealed novel aspects of infection including vertical and sexual transmission modes. Cases have been reported showing dramatic neurological pathologies including microcephaly and other neurodevelopmental problems in babies born to ZIKV infected mothers, as well as an increased risk of Guillain-Barre syndrome in adults. These findings prompted the World Health Organization to declare ZIKV a public health emergency in 2016, which resulted in expanded efforts to develop ZIKV vaccines and immunotherapeutics. Several ZIKV vaccine candidates that are immunogenic and effective at blocking ZIKV infection in animal models have since been developed, with some of these now being evaluated in the clinic. Additional therapeutics under investigation include anti-ZIKV monoclonal antibodies (mAbs) that have been shown to neutralize infection in vitro as well as protect against morbidity in mouse models of ZIKV infection. In this review, we summarize the current understanding of ZIKV biology and describe our efforts to rapidly develop a vaccine against ZIKV.

Project description:BackgroundThe major emerging infectious diseases (MEIDs) have occurred frequently and become increasingly serious in the world. Sufficient personal emergency preparedness is critical for the general people in efficiently responding to and recovering from MEIDs. Nevertheless, few specific indicators are available for assessing the individual emergency preparedness of the general public during these periods. Therefore, the aim of this study was to construct an index system for comprehensively evaluating the personal emergency preparedness of the public regarding MEIDs.MethodsBased on the global national-level emergency preparedness index framework and a literature review, a preliminary index system was constructed. From June 2022 to September 2022, a panel of 20 experts from nine provinces and municipalities across multiple research areas participated in this Delphi study. They rated the importance of pre-defined indicators using a five-point Likert scale and provided their qualitative comments. According to the feedback of each round of experts, the indicators of the evaluation index system were revised.ResultsAfter two rounds of expert consultation the evaluation index system reached a consensus, containing five first-level indicators, cooperating with prevention and control work, improving emergency response capacity, securing supplies and equipment, preparing economic resources, maintaining physical and mental health with affiliated 20 s-level indicators and 53 third-level indicators. The expert authority coefficient of consultation was 0.88 and 0.90. The Kendall's coefficient of concordance of expert consultations was 0.294 and 0.322, respectively. The differences were statistically significant (P < 0.05).ConclusionA valid, reliable and scientific evaluation index system was established. This personal emergency preparedness index system, as a precursor form, will further lay the foundation for the formation of an assessment instrument. At the same time, it could provide a reference for future education and training of emergency preparedness for the general public.

Project description:BackgroundAs demonstrated during the global Ebola crisis of 2014-2016, healthcare institutions in high resource settings need support concerning preparedness during threats of infectious disease outbreaks. This study aimed to exploratively develop a standardized preparedness system to use during unfolding threats of severe infectious diseases.MethodsA qualitative three-step study among infectious disease prevention and control experts was performed. First, interviews (n = 5) were conducted to identify which factors trigger preparedness activities during an unfolding threat. Second, these triggers informed the design of a phased preparedness system which was tested in a focus group discussion (n = 5) were conducted to identify which factors trigger preparedness activities during an unfolding threat. Second, these triggers informed the design of a phased preparedness system which was tested in a focus group discussion (n = 5) were conducted to identify which factors trigger preparedness activities during an unfolding threat. Second, these triggers informed the design of a phased preparedness system which was tested in a focus group discussion (.ResultsFour preparedness phases were identified: preparedness phase green is a situation without the presence of the infectious disease threat that requires centralized care, anywhere in the world. Phase yellow is an outbreak in the world with some likelihood of imported cases. Phase orange is a realistic chance of an unexpected case within the country, or unrest developing among population or staff; phase red is cases admitted to hospitals in the country, potentially causing a shortage of resources. Specific preparedness activities included infection prevention, diagnostics, patient care, staff, and communication. Consensus was reached on the need for the development of a preparedness system and national coordination during threats.ConclusionsIn this study, we developed a standardized system to support institutional preparedness during an increasing threat. Use of this system by both curative healthcare institutions and the (municipal) public health service, could help to effectively communicate and align preparedness activities during future threats of severe infectious diseases.

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Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development.

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Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development.

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