#Limiting factors for wearing personal protective equipment (#PPE) in a #healthcare #environment evaluated in a randomised study (PLoS One, abstract)

[Source: PLoS One, full page: (LINK). Abstract, edited.]

OPEN ACCESS /  PEER-REVIEWED / RESEARCH ARTICLE

Limiting factors for wearing personal protective equipment (PPE) in a health care environment evaluated in a randomised study

Martina Loibner, Sandra Hagauer, Gerold Schwantzer, Andrea Berghold, Kurt Zatloukal

Published: January 22, 2019 / DOI: https://doi.org/10.1371/journal.pone.0210775

 

Abstract

Pandemics and re-emerging diseases put pressure on the health care system to prepare for patient care and sample logistics requiring enhanced personnel protective equipment (PPE) for health care workers. We generated quantifiable data on ergonomics of PPE applicable in a health care setting by defining error rates and physically limiting factors due to PPE-induced restrictions. Nineteen study volunteers tested randomly allocated head- or full body-ventilated PPE suits equipped with powered-air-purifying-respirators and performed four different tasks (two laboratory tutorials, a timed test of selective attention and a test investigating reaction time, mobility, speed and physical exercise) during 6 working hours at 22°C on one day and 4 working hours at 28°C on another day. Error rates and physical parameters (fluid loss, body temperature, heart rate) were determined and ergonomic-related parameters were assessed hourly using assessment sheets. Depending on the PPE system the most restrictive factors, which however had no negative impact on performance (speed and error rate), were: reduced dexterity due to multiple glove layers, impaired visibility by flexible face shields and back pain related to the respirator of the fully ventilated suit. Heat stress and liquid loss were perceived as restrictive at a working temperature of 28°C but not 22°C.

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Citation: Loibner M, Hagauer S, Schwantzer G, Berghold A, Zatloukal K (2019) Limiting factors for wearing personal protective equipment (PPE) in a health care environment evaluated in a randomised study. PLoS ONE 14(1): e0210775. https://doi.org/10.1371/journal.pone.0210775

Editor: Regan Marsh, Brigham and Women’s Hospital, Harvard Medical School, UNITED STATES

Received: January 12, 2017; Accepted: December 29, 2018; Published: January 22, 2019

Copyright: © 2019 Loibner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the paper and its Supporting Information files.

Funding: We would like to acknowledge the Christian Doppler Research Fund (Austrian Federal Ministry of Science, Research and Economy, the National Foundation for Research, Technology and Development) and ERINHA (European Research Infrastructure on Highly Pathogenic Agents, FP7-INFRA-2010-2-2.8) for financial support of our research project to KZ. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Keywords: Pandemic Preparedness; Infectious Diseases; PPE; Healthcare workers.

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#H2 #influenza viruses: designing #vaccines against future H2 #pandemics (Biochem Soc Trans., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Biochem Soc Trans. 2019 Jan 15. pii: BST20180602. doi: 10.1042/BST20180602. [Epub ahead of print]

H2 influenza viruses: designing vaccines against future H2 pandemics.

Reneer ZB1, Ross TM2,3.

Author information: 1 Center for Vaccines and Immunology, University of Georgia, Athens, GA 30602, U.S.A. 2 Center for Vaccines and Immunology, University of Georgia, Athens, GA 30602, U.S.A. tedross@uga.edu. 3 Department of Infectious Diseases, University of Georgia, Athens, GA 30602, U.S.A.

 

Abstract

Influenza-related pathologies affect millions of people each year and the impact of influenza on the global economy and in our everyday lives has been well documented. Influenza viruses not only infect humans but also are zoonotic pathogens that infect various avian and mammalian species, which serve as viral reservoirs. While there are several strains of influenza currently circulating in animal species, H2 influenza viruses have a unique history and are of particular concern. The 1957 ‘Asian Flu’ pandemic was caused by H2N2 influenza viruses and circulated among humans from 1957 to 1968 before it was replaced by viruses of the H3N2 subtype. This review focuses on avian influenza viruses of the H2 subtype and the role these viruses play in human infections. H2 influenza viral infections in humans would present a unique challenge to medical and scientific researchers. Much of the world’s population lacks any pre-existing immunity to the H2N2 viruses that circulated 50-60 years ago. If viruses of this subtype began circulating in the human population again, the majority of people alive today would have no immunity to H2 influenza viruses. Since H2N2 influenza viruses have effectively circulated in people in the past, there is a need for additional research to characterize currently circulating H2 influenza viruses. There is also a need to stockpile vaccines that are effective against both historical H2 laboratory isolates and H2 viruses currently circulating in birds to protect against a future pandemic.

© 2019 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

KEYWORDS: H2N2; influenza; pandemic; vaccine; virus

PMID: 30647144 DOI: 10.1042/BST20180602

Keywords: Pandemic Influenza; H2N2; Avian Influenza; Vaccines.

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#Access by Design, Benefits if Convenient: A Closer Look at the #PIP Framework’s #SMTA (Milbank Q., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Milbank Q. 2019 Jan 13. doi: 10.1111/1468-0009.12364. [Epub ahead of print]

Access by Design, Benefits if Convenient: A Closer Look at the Pandemic Influenza Preparedness Framework’s Standard Material Transfer Agreements.

Rourke MF1.

Author information: 1 Griffith Law School, Griffith University and Australian Defence Force Malaria and Infectious Disease Institute.

 

Abstract

Policy Points Securing access to pathogen samples for research purposes is crucial for pandemic preparedness and responding to infectious disease outbreaks. The Pandemic Influenza Preparedness Framework (PIP Framework) is the only pathogen-specific international access and benefit-sharing (ABS) instrument. This analysis reveals that during an influenza pandemic, the PIP Framework will safeguard access to virus samples but may not be as effective in delivering the associated benefits, like vaccines and antivirals, to countries in need. The PIP Framework’s deficiencies must be addressed before an influenza pandemic and before this ABS model is extended to other human pathogens.

CONTEXT:

The World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework (PIP Framework) after being forced to grapple with the demands of developing countries for the fairer distribution of vaccines and antivirals created using influenza viruses isolated from within their territories. Though adopted as a nonbinding resolution, the PIP Framework has been praised for its novel legal approach to access and benefit-sharing (ABS), using Standard Material Transfer Agreements (SMTAs) to create binding terms and conditions on both providers and users of PIP biological materials. The PIP Framework’s SMTA1 regulates the movement of influenza viruses with human pandemic potential through the WHO’s Global Influenza Surveillance and Response System (GISRS) as it operates to monitor the spread of seasonal influenza and detect the emergence of pandemic strains. Member States give consent to the WHO to transfer their materials to third parties under the terms of a negotiated SMTA2. The SMTA2 details benefits such as vaccines and antivirals to be made available to the WHO for distribution in the event of an influenza pandemic.

METHODS:

I analyzed the PIP Framework, its SMTAs, and secondary sources to determine whether the PIP Framework will effectively function as an ABS instrument during an influenza pandemic.

FINDINGS:

The SMTAs do not create any direct or binding agreements between Member States and third-party recipients of influenza viruses. In the lead-up to and during a pandemic, the SMTA1 secures access to influenza viruses for the WHO, and the SMTA2 secures access for commercial users of virus samples, but the SMTA2 may be ineffective in securing tangible benefits for the sovereign providers of those materials.

CONCLUSIONS:

As the international community starts to consider how to best regulate access to nonpandemic influenza pathogen samples, it is imperative that we first address the shortcomings of the only pathogen-specific international ABS instrument available, and we should do so before it is put to the ultimate test.

© 2019 Milbank Memorial Fund.

KEYWORDS: PIP Framework; World Health Organization; access and benefit-sharing; genetic resources; pandemic influenza

PMID: 30637812 DOI: 10.1111/1468-0009.12364

Keywords: Pandemic Influenza; Pandemic Preparedness; International Cooperation.

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The #Geographic Variation of #Surveillance and #Zoonotic #Spillover Potential of #Influenza Viruses in Domestic #Poultry and #Swine (Open Forum Infect Dis., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Open Forum Infect Dis. 2018 Nov 27;5(12):ofy318. doi: 10.1093/ofid/ofy318. eCollection 2018 Dec.

The Geographic Variation of Surveillance and Zoonotic Spillover Potential of Influenza Viruses in Domestic Poultry and Swine.

Berger KA1,2, Pigott DM3, Tomlinson F1, Godding D1, Maurer-Stroh S4,5, Taye B4,6, Sirota FL4, Han A4,5, Lee RTC4, Gunalan V4, Eisenhaber F4,5, Hay SI3, Russell CA7.

Author information: 1 Department of Veterinary Medicine, University of Cambridge, United Kingdom. 2 Agrimetrics Ltd., Harpenden, United Kingdom. 3 Institute for Health Metrics and Evaluation, University of Washington, Seattle. 4 Bioinformatics Institute, ASTAR, Singapore. 5 National University of Singapore. 6 European Molecular Biology Laboratory, Deutsches Elektronen-Synchrotron, Hamburg, Germany. 7 Academic Medical Center, University of Amsterdam, The Netherlands.

 

Abstract

BACKGROUND:

Avian and swine influenza viruses circulate worldwide and pose threats to both animal and human health. The design of global surveillance strategies is hindered by information gaps on the geospatial variation in virus emergence potential and existing surveillance efforts.

METHODS:

We developed a spatial framework to quantify the geographic variation in outbreak emergence potential based on indices of potential for animal-to-human and secondary human-to-human transmission. We then compared our resultant raster model of variation in emergence potential with the global distribution of recent surveillance efforts from 359105 reports of surveillance activities.

RESULTS:

Our framework identified regions of Southeast Asia, Eastern Europe, Central America, and sub-Saharan Africa with high potential for influenza virus spillover. In the last 15 years, however, we found that 78.43% and 49.01% of high-risk areas lacked evidence of influenza virus surveillance in swine and domestic poultry, respectively.

CONCLUSIONS:

Our work highlights priority areas where improved surveillance and outbreak mitigation could enhance pandemic preparedness strategies.

KEYWORDS: avian influenza; outbreak; spillover; surveillance; swine influenza

PMID: 30619908 PMCID: PMC6309522 DOI: 10.1093/ofid/ofy318

Keywords: Avian Influenza; Poultry; Pigs; Pandemic preparedness.

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#PublicHealth–Driven #Research and Innovation for Next-Generation #Influenza #Vaccines, #EU (Emerg Infect Dis., abstract)

[Source: US Centers for Disease Control and Prevention (CDC), Emerging Infectious Diseases Journal, full page: (LINK). Abstract, edited.]

Volume 25, Number 2—February 2019 / Online Report

Public Health–Driven Research and Innovation for Next-Generation Influenza Vaccines, European Union

Adoración Navarro-Torné  , Finnian Hanrahan, Barbara Kerstiëns, Pilar Aguar, and Line Matthiessen

Author affiliations: European Commission Directorate-General for Research and Innovation, Brussels, Belgium

 

Abstract

Influenza virus infections are a major public health threat. Vaccination is available, but unpredictable antigenic changes in circulating strains require annual modification of seasonal influenza vaccines. Vaccine effectiveness has proven limited, particularly in certain groups, such as the elderly. Moreover, preparedness for upcoming pandemics is challenging because we can predict neither the strain that will cause the next pandemic nor the severity of the pandemic. The European Union fosters research and innovation to develop novel vaccines that evoke broadly protective and long-lasting immune responses against both seasonal and pandemic influenza, underpinned by a political commitment to global public health.

Keywords: Pandemic Influenza; Pandemic Preparedness; Vaccines; EU.

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The association between #socioeconomic status and #pandemic #influenza: protocol for a systematic review and meta-analysis (Syst Rev., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Syst Rev. 2019 Jan 4;8(1):5. doi: 10.1186/s13643-018-0931-2.

The association between socioeconomic status and pandemic influenza: protocol for a systematic review and meta-analysis.

Mamelund SE1, Shelley-Egan C2, Rogeberg O3.

Author information: 1 Work Research Institute at OsloMet – Oslo Metropolitan University, PO. Box 4, St. Olavs plass, 0130, Oslo, Norway. Svenn-Erik.Mamelund@oslomet.no. 2 Work Research Institute at OsloMet – Oslo Metropolitan University, PO. Box 4, St. Olavs plass, 0130, Oslo, Norway. 3 Frisch Centre, Gaustadalleen 21, 0349, Oslo, Norway.

 

Abstract

BACKGROUND:

Pandemic mortality rates in 1918 and in 2009 were highest among those with the lowest socioeconomic status (SES). Despite this, low SES groups are not included in the list of groups prioritized for pandemic vaccination, and the ambition to reduce social inequality in health does not feature in international and national pandemic preparedness plans. We describe plans for a systematic review and meta-analysis of the association between SES and pandemic outcomes during the last five pandemics.

METHOD:

The planned review will cover studies of pandemic influenza that report associations between morbidity, hospitalization, or mortality with socioeconomic factors such as education and income. The review will include published studies in the English, Danish, Norwegian, and Swedish languages, regardless of geographical location. Relevant records were identified through systematic literature searches in MEDLINE, Embase, Cinahl, SocIndex, Scopus, and Web of Science. Reference lists of relevant known studies will be screened and experts in the field consulted in order to identify other additional sources. Two investigators will independently screen and select studies, and discrepancies will be resolved through discussion until consensus is reached. Covidence will be used. Results will be summarized narratively and using three meta-analytic strategies: coefficients expressing the difference between the highest and lowest socioeconomic groups reported will be pooled using (a) fixed and random effects meta-analysis where studies involve similar outcome and exposure measures and (b) meta-regression where studies involve similar outcome measures. In addition, we will attempt to use all reported estimates for SES differences in (c) a Bayesian meta-analysis to estimate the underlying SES gradient and how it differs by outcome and exposure measure.

DISCUSSION:

This study will provide the first systematic review of research on the relation between SES and pandemic outcomes. The findings will be relevant for health policy in helping to assess whether people of low socioeconomic status should be prioritized for vaccines in preparedness plans for pandemic influenza. The review will also contribute to the research literature by providing pooled estimates of effect sizes as inputs into power calculations of future studies.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO 87922.

KEYWORDS: Education; Hospitalization; Housing conditions; Income; Morbidity; Mortality; Occupational social class; Pandemic influenza; Poverty; Socioeconomic status

PMID: 30609940 DOI: 10.1186/s13643-018-0931-2

Keywords: Pandemic Influenza; Pandemic Preparedness.

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Safety and #immunogenicity of #influenza A(#H5N1) #vaccine stored up to twelve years in the National Pre-#Pandemic Influenza Vaccine #Stockpile (NPIVS) (Vaccine, abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Vaccine. 2018 Dec 12. pii: S0264-410X(18)31632-3. doi: 10.1016/j.vaccine.2018.11.069. [Epub ahead of print]

Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS).

Oshansky CM1, Zhou J1, Gao Y1, Schweinle JE1, Biscardi K1, DeBeauchamp J2, Pavetto C1, Wollish A3; BRITE Study Coordination Team, Webby RJ2, Cioce V4, Donis RO5, Bright RA1.

Author information: 1 Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), Washington, DC, USA. 2 St. Jude Children’s Research Hospital, Memphis, TN, USA. 3 PPD, Wilmington, NC, USA. 4 Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), Washington, DC, USA. Electronic address: vittoria.cioce@hhs.gov. 5 Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), Washington, DC, USA. Electronic address: ruben.donis@hhs.gov.

 

Abstract

BACKGROUND:

As part of the U.S. Department of Health and Human Services (HHS) Pandemic Influenza Plan preparedness and response strategy, the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program was established by the Biomedical Advanced Research and Development Authority (BARDA) in 2005 with the goal of building and maintaining a stockpile of vaccines for influenza viruses with pandemic potential to vaccinate 20 million people in the critical workforce in the event of a pandemic. The NPIVS program continuously monitors the integrity of influenza vaccine antigens and adjuvants stored within the stockpile. In addition to monitoring physical and chemical properties in stability studies, it is important to regularly assess the safety and immunogenicity of stockpiled vaccines and adjuvants to maintain preparedness for use in the event of an influenza pandemic.

METHODS:

BARDA conducted a randomized, double-blinded Phase 2 clinical study with the oldest stockpiled influenza A(H5N1) antigen, stored over the previous 10-12 years administered with or without MF59® adjuvant, stored over the previous 2-7 years at the time of vaccination.

RESULTS:

Stockpiled vaccines were well-tolerated, adverse events were generally mild, and there was no drop in immunogenicity to the oldest stockpiled A(H5N1) vaccine. Compared to unadjuvanted vaccine, greater peak antibody responses were observed in subjects who were vaccinated with MF59-adjuvanted vaccines, regardless of antigen dose. Vaccination with the A(H5N1) vaccine antigen also results in cross-reactive antibody responses to contemporary circulating strains of A(H5) influenza viruses.

CONCLUSIONS:

The frequency, type, and severity of AEs observed during this study are similar to historical clinical study data with A(H5N1) vaccines and MF59 adjuvant indicating that a stockpiled A(H5N1) vaccine appears to remain safe and tolerable. The vaccines were immunogenic when administered as a two-dose vaccine regimen in healthy adults, despite extended storage of HA antigen or MF59 adjuvant within the NPIVS.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT02680002.

Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

KEYWORDS: Avian influenza; MF59; NPIVS; Stockpile; Vaccine

PMID: 30553570 DOI: 10.1016/j.vaccine.2018.11.069

Keywords: Pandemic Influenza; Pandemic Preparedness; USA; Vaccines; H5N1.

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