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  1. Article ; Online: Protecting Olympic Participants from Covid-19 - The Urgent Need for a Risk-Management Approach.

    Sparrow, Annie K / Brosseau, Lisa M / Harrison, Robert J / Osterholm, Michael T

    The New England journal of medicine

    2021  Volume 385, Issue 1, Page(s) e2

    MeSH term(s) Athletes ; COVID-19/prevention & control ; COVID-19/transmission ; Communicable Disease Control/methods ; Communicable Disease Control/standards ; Disease Transmission, Infectious/prevention & control ; Humans ; International Agencies ; Internationality ; Risk Assessment ; Sports ; Tokyo ; World Health Organization
    Language English
    Publishing date 2021-05-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMp2108567
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: One vaccine to counter many diseases? Modeling the economics of oral polio vaccine against child mortality and COVID-19.

    Chang, Angela Y / Aaby, Peter / Avidan, Michael S / Benn, Christine S / Bertozzi, Stefano M / Blatt, Lawrence / Chumakov, Konstantin / Khader, Shabaana A / Kottilil, Shyam / Nekkar, Madhav / Netea, Mihai G / Sparrow, Annie / Jamison, Dean T

    Frontiers in public health

    2022  Volume 10, Page(s) 967920

    Abstract: Introduction: Recent reviews summarize evidence that some vaccines have heterologous or non-specific effects (NSE), potentially offering protection against multiple pathogens. Numerous economic evaluations examine vaccines' pathogen-specific effects, ... ...

    Abstract Introduction: Recent reviews summarize evidence that some vaccines have heterologous or non-specific effects (NSE), potentially offering protection against multiple pathogens. Numerous economic evaluations examine vaccines' pathogen-specific effects, but less than a handful focus on NSE. This paper addresses that gap by reporting economic evaluations of the NSE of oral polio vaccine (OPV) against under-five mortality and COVID-19.
    Materials and methods: We studied two settings: (1) reducing child mortality in a high-mortality setting (Guinea-Bissau) and (2) preventing COVID-19 in India. In the former, the intervention involves three annual campaigns in which children receive OPV incremental to routine immunization. In the latter, a susceptible-exposed-infectious-recovered model was developed to estimate the population benefits of two scenarios, in which OPV would be co-administered alongside COVID-19 vaccines. Incremental cost-effectiveness and benefit-cost ratios were modeled for ranges of intervention effectiveness estimates to supplement the headline numbers and account for heterogeneity and uncertainty.
    Results: For child mortality, headline cost-effectiveness was $650 per child death averted. For COVID-19, assuming OPV had 20% effectiveness, incremental cost per death averted was $23,000-65,000 if it were administered simultaneously with a COVID-19 vaccine <200 days into a wave of the epidemic. If the COVID-19 vaccine availability were delayed, the cost per averted death would decrease to $2600-6100. Estimated benefit-to-cost ratios vary but are consistently high.
    Discussion: Economic evaluation suggests the potential of OPV to efficiently reduce child mortality in high mortality environments. Likewise, within a broad range of assumed effect sizes, OPV (or another vaccine with NSE) could play an economically attractive role against COVID-19 in countries facing COVID-19 vaccine delays.
    Funding: The contribution by DTJ was supported through grants from Trond Mohn Foundation (BFS2019MT02) and Norad (RAF-18/0009) through the Bergen Center for Ethics and Priority Setting.
    MeSH term(s) Child ; Humans ; COVID-19 Vaccines ; Child Mortality ; Poliomyelitis/prevention & control ; COVID-19/prevention & control ; Immunization Programs ; Poliovirus Vaccine, Oral
    Chemical Substances COVID-19 Vaccines ; Poliovirus Vaccine, Oral
    Language English
    Publishing date 2022-10-05
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2711781-9
    ISSN 2296-2565 ; 2296-2565
    ISSN (online) 2296-2565
    ISSN 2296-2565
    DOI 10.3389/fpubh.2022.967920
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  3. Article ; Online: Defining Polio: Closing the Gap in Global Surveillance.

    Tajaldin, Bachir / Almilaji, Khaled / Langton, Paul / Sparrow, Annie

    Annals of global health

    2015  Volume 81, Issue 3, Page(s) 386–395

    Abstract: Background: By late 2012 the Global Polio Eradication Initiative (GPEI) had nearly eradicated this ancient infectious disease. Successful surveillance programs for acute flaccid paralysis however rely on broad governmental support for implementation. ... ...

    Abstract Background: By late 2012 the Global Polio Eradication Initiative (GPEI) had nearly eradicated this ancient infectious disease. Successful surveillance programs for acute flaccid paralysis however rely on broad governmental support for implementation. With the onset of conflict, public health breakdown has contributed to the resurgence of polio in a number of regions. The current laboratory based case definition may be a contributory factor in these regions.
    Objective: We sought to compare case definition rates using strict laboratory based criteria to rates obtained using the clinical criteria in modern day Syria. We also sought to examine this distribution of cases by sub-region.
    Methods: We examined the World Health Organization (WHO) reported figures for Syria from 2013-2014 using laboratory based criteria. We compared these with cases obtained when clinical criteria were applied. In addition we sought data from the opposition controlled Assistance Coordination Unit which operates in non-Government controlled areas where WHO data maybe incomplete. Cases were carefully examined for potential overlap to avoid double reporting.
    Findings: Whilst the WHO data clearly confirmed the polio outbreak in Syria, it did so with considerable delay and with under reporting of cases, particularly from non-government controlled areas. In addition, laboratory based case definition led to a substantial underestimate of polio (36 cases) compared with those found with the clinically compatible definition (an additional 46 cases). Rates of adequate diagnostic specimens from suspected cases are well below target, no doubt reflecting the effect of conflict in these areas.
    Conclusions: We have identified a gap in the surveillance of polio, a global threat. The current laboratory based definition, in the setting of conflict and insecurity, leads to under diagnosis of polio with potential delays and inadequacies in coordinating effective responses to contain outbreaks and eradicate polio. Breakdown in public health measures as a contributing factor is likely to result in a resurgence of previously controlled infectious diseases. The clinical definition should be reinstituted to supplement the lab-based definition.
    MeSH term(s) Armed Conflicts ; Child ; Disease Eradication ; Disease Outbreaks ; Epidemiological Monitoring ; Global Health ; Humans ; Poliomyelitis/diagnosis ; Poliomyelitis/epidemiology ; Poliomyelitis/prevention & control ; Poliovirus Vaccines/therapeutic use ; Syria/epidemiology ; World Health Organization
    Chemical Substances Poliovirus Vaccines
    Language English
    Publishing date 2015-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2821756-1
    ISSN 2214-9996 ; 2214-9996
    ISSN (online) 2214-9996
    ISSN 2214-9996
    DOI 10.1016/j.aogh.2015.06.007
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  4. Article: Cholera in the time of war: implications of weak surveillance in Syria for the WHO's preparedness-a comparison of two monitoring systems.

    Sparrow, Annie / Almilaji, Khaled / Tajaldin, Bachir / Teodoro, Nicholas / Langton, Paul

    BMJ global health

    2016  Volume 1, Issue 3, Page(s) e000029

    Abstract: Background: Public health breakdown from the Syrian government's targeting of healthcare systems in politically unsympathetic areas has yielded a resurgence of infectious diseases. Suspected cholera recently reappeared but conflict-related constraints ... ...

    Abstract Background: Public health breakdown from the Syrian government's targeting of healthcare systems in politically unsympathetic areas has yielded a resurgence of infectious diseases. Suspected cholera recently reappeared but conflict-related constraints impede laboratory confirmation. Given the government's previous under-reporting of infectious outbreaks and the reliance of the WHO on government reporting, we sought to assess the reliability of current surveillance systems.
    Methods: We compared weekly surveillance reports of waterborne diseases from the Syrian government's (WHO-associated) Early Warning and Response System (EWARS), based in Damascus, and the independent, non-governmental Early Warning and Response Network (EWARN) headquartered in Gaziantep, Turkey. We compared raw case rates by EWARS and EWARN and assessed the quality of reporting against the WHO benchmarks.
    Results: We identified significant under-reporting and delays in the government's surveillance. On average, EWARS reports were published 24 days (range 12-61) after the reference week compared with 11 days (5-21) for EWARN. Average completeness for EWARS was 75% (55-84%), compared with 92% for EWARN (85-99%). Average timeliness for EWARS was 79% (51-100%), compared with 88% for EWARN (70-97%). EWARS made limited use of rapid diagnostic tests, and rates of collection of stool samples for laboratory cholera testing were well below reference levels.
    Conclusions: In the context of the current Syrian war, the government's surveillance is inadequate due to lack of access to non-government held territory, an incentive to under-report the consequence of government attacks on health infrastructure, and an impractical insistence on laboratory confirmation. These findings should guide the WHO reform for surveillance in conflict zones.
    Language English
    Publishing date 2016
    Publishing country England
    Document type Journal Article
    ISSN 2059-7908
    ISSN 2059-7908
    DOI 10.1136/bmjgh-2016-000029
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  5. Article ; Online: Old vaccines for new infections: Exploiting innate immunity to control COVID-19 and prevent future pandemics.

    Chumakov, Konstantin / Avidan, Michael S / Benn, Christine S / Bertozzi, Stefano M / Blatt, Lawrence / Chang, Angela Y / Jamison, Dean T / Khader, Shabaana A / Kottilil, Shyam / Netea, Mihai G / Sparrow, Annie / Gallo, Robert C

    Proceedings of the National Academy of Sciences of the United States of America

    2021  Volume 118, Issue 21

    Abstract: The COVID-19 pandemic triggered an unparalleled pursuit of vaccines to induce specific adaptive immunity, based on virus-neutralizing antibodies and T cell responses. Although several vaccines have been developed just a year after SARS-CoV-2 emerged in ... ...

    Abstract The COVID-19 pandemic triggered an unparalleled pursuit of vaccines to induce specific adaptive immunity, based on virus-neutralizing antibodies and T cell responses. Although several vaccines have been developed just a year after SARS-CoV-2 emerged in late 2019, global deployment will take months or even years. Meanwhile, the virus continues to take a severe toll on human life and exact substantial economic costs. Innate immunity is fundamental to mammalian host defense capacity to combat infections. Innate immune responses, triggered by a family of pattern recognition receptors, induce interferons and other cytokines and activate both myeloid and lymphoid immune cells to provide protection against a wide range of pathogens. Epidemiological and biological evidence suggests that the live-attenuated vaccines (LAV) targeting tuberculosis, measles, and polio induce protective innate immunity by a newly described form of immunological memory termed "trained immunity." An LAV designed to induce adaptive immunity targeting a particular pathogen may also induce innate immunity that mitigates other infectious diseases, including COVID-19, as well as future pandemic threats. Deployment of existing LAVs early in pandemics could complement the development of specific vaccines, bridging the protection gap until specific vaccines arrive. The broad protection induced by LAVs would not be compromised by potential antigenic drift (immune escape) that can render viruses resistant to specific vaccines. LAVs might offer an essential tool to "bend the pandemic curve," averting the exhaustion of public health resources and preventing needless deaths and may also have therapeutic benefits if used for postexposure prophylaxis of disease.
    MeSH term(s) Adaptive Immunity ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/immunology ; Immunity, Heterologous ; Immunity, Innate ; Immunologic Memory ; Pandemics/prevention & control ; SARS-CoV-2/immunology ; Vaccines/immunology ; Vaccines, Attenuated/immunology
    Chemical Substances COVID-19 Vaccines ; Vaccines ; Vaccines, Attenuated
    Language English
    Publishing date 2021-05-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 209104-5
    ISSN 1091-6490 ; 0027-8424
    ISSN (online) 1091-6490
    ISSN 0027-8424
    DOI 10.1073/pnas.2101718118
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    Zs.A 1148: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  6. Article ; Online: One vaccine to counter many diseases? Modelling the economics of oral polio vaccine against child mortality and COVID-19

    Chang, Angela Y / Aaby, Peter / Avidan, Michael S / Benn, Christine S / Bertozzi, Stefano M / Blatt, Lawrence / Chumakov, Konstantin / Khader, Shabaana A / Kottilil, Shyam / Nekkar, Madhav / Netea, Mihai G / Sparrow, Annie / Jamison, Dean T

    medRxiv

    Abstract: Background: Recent reviews summarize evidence that some vaccines have heterologous or non-specific effects (NSE), potentially offering protection against multiple pathogens. Numerous economic evaluations examine vaccines9 pathogen-specific effects, but ... ...

    Abstract Background: Recent reviews summarize evidence that some vaccines have heterologous or non-specific effects (NSE), potentially offering protection against multiple pathogens. Numerous economic evaluations examine vaccines9 pathogen-specific effects, but we have found only two economic evaluations of NSE. This paper starts to fill this gap by reporting economic evaluations of the NSE of oral polio vaccine (OPV) against under-five mortality and COVID-19. Methods: We studied two settings: (1) reducing child mortality in a high-mortality setting (Guinea-Bissau) and (2) preventing COVID-19 in India. In the former, the intervention involves three annual campaigns in which children receive OPV incremental to routine immunization. In the latter, a susceptible-exposed-infectious-recovered model was developed to estimate the population benefits of two scenarios, in which OPV would be co-administered alongside COVID-19 vaccines. Incremental cost-effectiveness and benefit-cost ratios were modelled for ranges of intervention effectiveness estimates to supplement the headline numbers and account for heterogeneity and uncertainty. Results: For child mortality, headline cost-effectiveness was $650 per child death averted. For COVID-19, assuming OPV had 20% effectiveness, incremental cost per death averted was $23,000-65,000 if it were administered simultaneously with a COVID-19 vaccine less than 200 days into a wave of the epidemic. If the COVID-19 vaccine availability were delayed, the cost per averted death would decrease to $2600-6100. Estimated benefit-to-cost ratios vary but are consistently high. Conclusion: Economic evaluation suggests the potential of OPV to efficiently reduce child mortality in high mortality environments. Likewise, within a broad range of assumed effect sizes OPV could play an economically attractive role against COVID-19.
    Keywords covid19
    Language English
    Publishing date 2022-01-21
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2022.01.19.22269560
    Database COVID19

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  7. Article ; Online: Epigenome-wide DNA methylation in leukocytes and toenail metals: The normative aging study.

    Wang, Cuicui / Xu, Zongli / Qiu, Xinye / Wei, Yaguang / Peralta, Adjani A / Yazdi, Mahdieh Danesh / Jin, Tingfan / Li, Wenyuan / Just, Allan / Heiss, Jonathan / Hou, Lifang / Zheng, Yinan / Coull, Brent A / Kosheleva, Anna / Sparrow, David / Amarasiriwardena, Chitra / Wright, Robert O / Baccarelli, Andrea A / Schwartz, Joel D

    Environmental research

    2022  Volume 217, Page(s) 114797

    Abstract: ... with the Illumina HumanMethylation450 K BeadChip. We first performed median regression to evaluate the effects ...

    Abstract Background: Environmental metal exposures have been associated with multiple deleterious health endpoints. DNA methylation (DNAm) may provide insight into the mechanisms underlying these relationships. Toenail metals are non-invasive biomarkers, reflecting a medium-term time exposure window.
    Objectives: This study examined variation in leukocyte DNAm and toenail arsenic (As), cadmium (Cd), lead (Pb), manganese (Mn), and mercury (Hg) among elderly men in the Normative Aging Study, a longitudinal cohort.
    Methods: We repeatedly collected samples of blood and toenail clippings. We measured DNAm in leukocytes with the Illumina HumanMethylation450 K BeadChip. We first performed median regression to evaluate the effects of each individual toenail metal on DNAm at three levels: individual cytosine-phosphate-guanine (CpG) sites, regions, and pathways. Then, we applied a Bayesian kernel machine regression (BKMR) to assess the joint and individual effects of metal mixtures on DNAm. Significant CpGs were identified using a multiple testing correction based on the independent degrees of freedom approach for correlated outcomes. The approach considers the effective degrees of freedom in the DNAm data using the principal components that explain >95% variation of the data.
    Results: We included 564 subjects (754 visits) between 1999 and 2013. The numbers of significantly differentially methylated CpG sites, regions, and pathways varied by metals. For example, we found six significant pathways for As, three for Cd, and one for Mn. The As-associated pathways were associated with cancer (e.g., skin cancer) and cardiovascular disease, whereas the Cd-associated pathways were related to lung cancer. Metal mixtures were also associated with 47 significant CpG sites, as well as pathways, mainly related to cancer and cardiovascular disease.
    Conclusions: This study provides an approach to understanding the potential epigenetic mechanisms underlying observed relations between toenail metals and adverse health endpoints.
    MeSH term(s) Male ; Humans ; Aged ; DNA Methylation ; Cadmium ; Epigenome ; Nails ; Cardiovascular Diseases ; Bayes Theorem ; Metals/toxicity ; Aging ; Arsenic/toxicity ; Leukocytes ; Mercury ; Manganese
    Chemical Substances Cadmium (00BH33GNGH) ; Metals ; Arsenic (N712M78A8G) ; Mercury (FXS1BY2PGL) ; Manganese (42Z2K6ZL8P)
    Language English
    Publishing date 2022-11-12
    Publishing country Netherlands
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 205699-9
    ISSN 1096-0953 ; 0013-9351
    ISSN (online) 1096-0953
    ISSN 0013-9351
    DOI 10.1016/j.envres.2022.114797
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    Zs.A 726: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  8. Book ; Online: Ideas and perspectives

    Wilson, Samuel T. / Al-Haj, Alia N. / Bourbonnais, Annie / Frey, Claudia / Fulweiler, Robinson W. / Kessler, John D. / Marchant, Hannah K. / Milucka, Jana / Ray, Nicholas E. / Suntharalingam, Parvadha / Thornton, Brett F. / Upstill-Goddard, Robert C. / Weber, Thomas S. / Arévalo-Martínez, Damian L. / Bange, Hermann W. / Benway, Heather M. / Bianchi, Daniele / Borges, Alberto V. / Chang, Bonnie X. /
    Crill, Patrick M. / Valle, Daniela A. / Farías, Laura / Joye, Samantha B. / Kock, Annette / Labidi, Jabrane / Manning, Cara C. / Pohlman, John W. / Rehder, Gregor / Sparrow, Katy J. / Tortell, Philippe D. / Treude, Tina / Valentine, David L. / Ward, Bess B. / Yang, Simon / Yurganov, Leonid N.

    eISSN: 1726-4189

    A strategic assessment of methane and nitrous oxide measurements in the marine environment

    2020  

    Abstract: In the current era of rapid climate change, accurate characterization of climate-relevant gas dynamics – namely production, consumption, and net emissions – is required for all biomes, especially those ecosystems most susceptible to the impact of change. ...

    Abstract In the current era of rapid climate change, accurate characterization of climate-relevant gas dynamics – namely production, consumption, and net emissions – is required for all biomes, especially those ecosystems most susceptible to the impact of change. Marine environments include regions that act as net sources or sinks for numerous climate-active trace gases including methane (CH 4 ) and nitrous oxide (N 2 O). The temporal and spatial distributions of CH 4 and N 2 O are controlled by the interaction of complex biogeochemical and physical processes. To evaluate and quantify how these mechanisms affect marine CH 4 and N 2 O cycling requires a combination of traditional scientific disciplines including oceanography, microbiology, and numerical modeling. Fundamental to these efforts is ensuring that the datasets produced by independent scientists are comparable and interoperable. Equally critical is transparent communication within the research community about the technical improvements required to increase our collective understanding of marine CH 4 and N 2 O. A workshop sponsored by Ocean Carbon and Biogeochemistry (OCB) was organized to enhance dialogue and collaborations pertaining to marine CH 4 and N 2 O. Here, we summarize the outcomes from the workshop to describe the challenges and opportunities for near-future CH 4 and N 2 O research in the marine environment.
    Subject code 333
    Language English
    Publishing date 2020-12-09
    Publishing country de
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Ideas and perspectives

    Wilson, Samuel T. / Al-Haj, Alia N. / Bourbonnais, Annie / Frey, Claudia / Fulweiler, Robinson W. / Kessler, John D. / Marchant, Hannah K. / Milucka, Jana / Ray, Nicholas E. / Suntharalingam, Parvadha / Thornton, Brett F. / Upstill-Goddard, Robert C. / Weber, Thomas S. / Arevalo-Martinez, Damian L. / Bange, Hermann W. / Benway, Heather M. / Bianchi, Daniele / Borges, Alberto V. / Chang, Bonnie X. /
    Crill, Patrick M. / del Valle, Daniela A. / Farías, Laura / Joye, Samantha B. / Kock, Annette / Labidi, Jabrane / Manning, Cara C. / Pohlman, John W. / Rehder, Gregor / Sparrow, Katy J. / Tortell, Philippe D. / Treude, Tina / Valentine, David L. / Ward, Bess B. / Yang, Simon / Yurganov, Leonid N.

    A strategic assessment of methane and nitrous oxide measurements in the marine environment

    2020  

    Abstract: In the current era of rapid climate change, accurate characterization of climate-relevant gas dynamics-namely production, consumption, and net emissions-is required for all biomes, especially those ecosystems most susceptible to the impact of change. ... ...

    Abstract In the current era of rapid climate change, accurate characterization of climate-relevant gas dynamics-namely production, consumption, and net emissions-is required for all biomes, especially those ecosystems most susceptible to the impact of change. Marine environments include regions that act as net sources or sinks for numerous climateactive trace gases including methane (CH4) and nitrous oxide (N2O). The temporal and spatial distributions of CH4 and N2O are controlled by the interaction of complex biogeochemical and physical processes. To evaluate and quantify how these mechanisms affect marine CH4 and N2O cycling requires a combination of traditional scientific disciplines including oceanography, microbiology, and numerical modeling. Fundamental to these efforts is ensuring that the datasets produced by independent scientists are comparable and interoperable. Equally critical is transparent communication within the research community about the technical improvements required to increase our collective understanding of marine CH4 and N2O. A workshop sponsored by Ocean Carbon and Biogeochemistry (OCB) was organized to enhance dialogue and collaborations pertaining to marine CH4 and N2O. Here, we summarize the outcomes from the workshop to describe the challenges and opportunities for near-future CH4 and N2O research in the marine environment.
    Subject code 333
    Language English
    Publishing date 2020-11-26
    Publisher Copernicus Publications (EGU)
    Publishing country de
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial.

    Vanni, Tazio / Thomé, Beatriz C / Sparrow, Erin / Friede, Martin / Fox, Christopher B / Beckmann, Anna Marie / Huynh, Chuong / Mondini, Gabriella / Silveira, Daniela H / Viscondi, Juliana Y K / Braga, Patrícia Emilia / Silva, Anderson da / Salomão, Maria da Graça / Piorelli, Roberta O / Santos, Joane P / Gattás, Vera Lúcia / Lucchesi, Maria Beatriz B / Oliveira, Mayra M M de / Koike, Marcelo E /
    Kallas, Esper G / Campos, Lucia M A / Coelho, Eduardo B / Siqueira, Marilda A M / Garcia, Cristiana C / Miranda, Milene Dias / Paiva, Terezinha M / Timenetsky, Maria do Carmo S T / Adami, Eduardo A / Akamatsu, Milena A / Ho, Paulo Lee / Precioso, Alexander R

    PloS one

    2022  Volume 17, Issue 10, Page(s) e0274943

    Abstract: The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion ... ...

    Abstract The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion formulations (IB160 and SE) with influenza A/H7N9 antigen. This phase I, randomized, double-blind, placebo-controlled, dose-finding trial (NCT03330899), enrolled 432 healthy volunteers aged 18 to 59. Participants were randomly allocated to 8 groups: 1A) IB160 + 15μg H7N9, 1B) IB160 + 7.5μg H7N9, 1C) IB160 + 3.75μg H7N9, 2A) SE + 15μg H7N9, 2B) SE + 7.5μg H7N9, 2C) SE + 3.75μg H7N9, 3) unadjuvanted vaccine 15μg H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers ≥40 in 45.2% of participants (MN titers ≥40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers ≥40 in 22.9% of participants (MN titers ≥40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.
    MeSH term(s) Humans ; Influenza, Human ; Squalene ; Influenza A Virus, H7N9 Subtype ; Influenza Vaccines ; Pandemics/prevention & control ; Polysorbates ; Emulsions ; Antibodies, Viral ; Hemagglutination Inhibition Tests ; Adjuvants, Immunologic ; Adjuvants, Pharmaceutic ; Water
    Chemical Substances Squalene (7QWM220FJH) ; Influenza Vaccines ; Polysorbates ; Emulsions ; Antibodies, Viral ; Adjuvants, Immunologic ; Adjuvants, Pharmaceutic ; Water (059QF0KO0R)
    Language English
    Publishing date 2022-10-18
    Publishing country United States
    Document type Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0274943
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    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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