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human influenza challenge

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https://www.readbyqxmd.com/read/28639229/pharmacokinetics-of-mhaa4549a-an-anti-influenza-a-monoclonal-antibody-in-healthy-subjects-challenged-with-influenza%C3%A2-a-virus-in-a-phase-iia-randomized-trial
#1
Rong Deng, Ai Ping Lee, Mauricio Maia, Jeremy J Lim, Tracy Burgess, Priscilla Horn, Michael A Derby, Elizabeth Newton, Jorge A Tavel, William D Hanley
BACKGROUND AND OBJECTIVES: MHAA4549A, a human anti-influenza immunoglobulin (Ig) G1 monoclonal antibody, is being developed to treat patients hospitalized for influenza A infection. This study examined the pharmacokinetics (PKs) of MHAA4549A in a phase IIa, randomized, double-blind, dose-ranging trial in healthy volunteers challenged with influenza A virus. METHODS: Serum PK data were collected from 60 subjects in three single-dose groups (400, 1200, or 3600 mg) who received MHAA4549A intravenously 24-36 h after inoculation with the influenza A virus...
June 21, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28606804/a-human-challenge-model-for-respiratory-syncytial-virus-kinetics-the-pharmacological-effect-of-a-novel-fusion-inhibitor-and-the-modeling-of-symptoms-scores
#2
Julia Korell, Bruce Green, John DeVincenzo, Dymphy Huntjens
Respiratory syncytial virus (RSV) causes acute lower respiratory tract infections, and is a major cause of hospital admissions and death in young children. Limited treatments currently exist that can prevent or minimise exacerbation of the disease. The aims of this work were: 1) to develop a population pharmacodynamic model to describe RSV kinetics (RSVK) in nasal lavage, 2) evaluate the impact of an investigational fusion inhibitor, JNJ-53718678, on RSVK, and 3) determine the relationship between RSVK and symptoms scores...
June 9, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28604586/influenza-omics-and-the-host-response-recent-advances-and-future-prospects
#3
REVIEW
Joshua D Powell, Katrina M Waters
Influenza A viruses (IAV) continually evolve and have the capacity to cause global pandemics. Because IAV represents an ongoing threat, identifying novel therapies and host innate immune factors that contribute to IAV pathogenesis is of considerable interest. This review summarizes the relevant literature as it relates to global host responses to influenza infection at both the proteome and transcriptome level. The various-omics infection systems that include but are not limited to ferrets, mice, pigs, and even the controlled infection of humans are reviewed...
June 10, 2017: Pathogens
https://www.readbyqxmd.com/read/28595644/development-of-an-objective-gene-expression-panel-as-an-alternative-to-self-reported-symptom-scores-in-human-influenza-challenge-trials
#4
Julius Muller, Eneida Parizotto, Richard Antrobus, James Francis, Campbell Bunce, Amanda Stranks, Marshall Nichols, Micah McClain, Adrian V S Hill, Adaikalavan Ramasamy, Sarah C Gilbert
BACKGROUND: Influenza challenge trials are important for vaccine efficacy testing. Currently, disease severity is determined by self-reported scores to a list of symptoms which can be highly subjective. A more objective measure would allow for improved data analysis. METHODS: Twenty-one volunteers participated in an influenza challenge trial. We calculated the daily sum of scores (DSS) for a list of 16 influenza symptoms. Whole blood collected at baseline and 24, 48, 72 and 96 h post challenge was profiled on Illumina HT12v4 microarrays...
June 8, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28592526/novel-cross-reactive-monoclonal-antibodies-against-ebolavirus-glycoproteins-show-protection-in-a-murine-challenge-model
#5
Jim Duehr, Teddy John Wohlbold, Lisa Oestereich, Veronika Chromikova, Fatima Amanat, Madhusudan Rajendran, Sergio Gomez-Medina, Ignacio Mena, Benjamin R TenOever, Adolfo García-Sastre, Christopher F Basler, Cesar Munoz-Fontela, Florian Krammer
Out of an estimated 31,100 cases since its discovery in 1976, ebolaviruses have caused approximately 13,000 deaths. The vast majority (∼11,000) of these occurred during the 2013-2016 West African epidemic. Three out of five species in the genus are known to cause Ebola Virus Disease in humans. Several monoclonal antibodies against the ebolavirus glycoprotein are currently in development as therapeutics. However, there is still a paucity of monoclonal antibodies that can cross-react between the glycoproteins of different ebolavirus species and the mechanism of these monoclonal antibody therapeutics are still not understood in detail...
June 7, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28581455/attenuation-of-rna-viruses-by-redirecting-their-evolution-in-sequence-space
#6
Gonzalo Moratorio, Rasmus Henningsson, Cyril Barbezange, Lucia Carrau, Antonio V Bordería, Hervé Blanc, Stephanie Beaucourt, Enzo Z Poirier, Thomas Vallet, Jeremy Boussier, Bryan C Mounce, Magnus Fontes, Marco Vignuzzi
RNA viruses pose serious threats to human health. Their success relies on their capacity to generate genetic variability and, consequently, on their adaptive potential. We describe a strategy to attenuate RNA viruses by altering their evolutionary potential. We rationally altered the genomes of Coxsackie B3 and influenza A viruses to redirect their evolutionary trajectories towards detrimental regions in sequence space. Specifically, viral genomes were engineered to harbour more serine and leucine codons with nonsense mutation targets: codons that could generate Stop mutations after a single nucleotide substitution...
June 5, 2017: Nature Microbiology
https://www.readbyqxmd.com/read/28567036/nasal-iga-provides-protection-against-human-influenza-challenge-in-volunteers-with-low-serum-influenza-antibody-titre
#7
Victoria M W Gould, James N Francis, Katie J Anderson, Bertrand Georges, Alethea V Cope, John S Tregoning
In spite of there being a number of vaccines, influenza remains a significant global cause of morbidity and mortality. Understanding more about natural and vaccine induced immune protection against influenza infection would help to develop better vaccines. Virus specific IgG is a known correlate of protection, but other factors may help to reduce viral load or disease severity, for example IgA. In the current study we measured influenza specific responses in a controlled human infection model using influenza A/California/2009 (H1N1) as the challenge agent...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28559489/in-vivo-imaging-of-influenza-virus-infection-in-immunized-mice
#8
Rita Czakó, Leatrice Vogel, Elaine W Lamirande, Kevin W Bock, Ian N Moore, Ali H Ellebedy, Rafi Ahmed, Andrew Mehle, Kanta Subbarao
Immunization is the cornerstone of seasonal influenza control and represents an important component of pandemic preparedness strategies. Using a bioluminescent reporter virus, we demonstrate the application of noninvasive in vivo imaging system (IVIS) technology to evaluate the preclinical efficacy of candidate vaccines and immunotherapy in a mouse model of influenza. Sequential imaging revealed distinct spatiotemporal kinetics of bioluminescence in groups of mice passively or actively immunized by various strategies that accelerated the clearance of the challenge virus at different rates and by distinct mechanisms...
May 30, 2017: MBio
https://www.readbyqxmd.com/read/28536432/nuclear-translocation-of-hif-1%C3%AE-induced-by-influenza-a-h1n1-infection-is-critical-to-the-production-of-proinflammatory-cytokines
#9
Xinkun Guo, Zhaoqin Zhu, Wanju Zhang, Xiaoxiao Meng, Yong Zhu, Peng Han, Xiaohui Zhou, Yunwen Hu, Ruilan Wang
Infection with the influenza A (H1N1) virus is a major challenge for public health because it can cause severe morbidity and even mortality in humans. The over-secretion of inflammatory cytokines (cytokine storm) is considered to be a key contributor to the severe pneumonia caused by H1N1 infection. It has been reported that hypoxia-inducible factor 1-alpha (HIF-1α) is associated with the production of proinflammatory molecules, but whether HIF-1α participates in the acute inflammatory responses against H1N1 infection is still unclear...
May 24, 2017: Emerging Microbes & Infections
https://www.readbyqxmd.com/read/28505524/inactivated-influenza-virus-vaccines-the-future-of-tiv-and-qiv
#10
REVIEW
Michael Schotsaert, Adolfo García-Sastre
Influenza viruses continue to be a major public health concern, despite the availability of vaccines. Currently licensed influenza vaccines aim at the induction of antibodies that target hemagglutinin, the major antigenic determinant on the surface of influenza virions that is responsible for attachment of the virus to the host cell that is to be infected. Currently licensed influenza vaccines come as inactivated or live attenuated influenza vaccines and are trivalent or quadrivalent as they contain antigens of two influenza A and one or two influenza B strains that circulate in the human population, respectively...
May 12, 2017: Current Opinion in Virology
https://www.readbyqxmd.com/read/28500340/both-haemagglutinin-specific-antibody-and-t-cell-responses-induced-by-a-chimpanzee-adenoviral-vaccine-confer-protection-against-influenza-h7n9-viral-challenge
#11
Xiang Wang, Weihui Fu, Songhua Yuan, Xi Yang, Yufeng Song, Lulu Liu, Yudan Chi, Tao Cheng, Man Xing, Yan Zhang, Chao Zhang, Yong Yang, Caihong Zhu, Xiaoyan Zhang, Sidong Xiong, Jianqing Xu, Dongming Zhou
Since 2013, the outbreak or sporadic infection of a new reassortant H7N9 influenza virus in China has resulted in hundreds of deaths and thousands of illnesses. An H7N9 vaccine is urgently needed, as a licensed human vaccine against H7N9 influenza is currently not available. Here, we developed a recombinant adenovirus-based vaccine, AdC68-H7HA, by cloning the H7N9 haemagglutinin (HA) gene into the chimpanzee adenoviral vector AdC68. The efficacy of AdC68-H7HA was evaluated in mice as well as guinea pigs. For comparison, an H7N9 DNA vaccine based on HA was also generated and tested in mice and guinea pigs...
May 12, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28499553/nasal-delivery-of-protollin-adjuvanted-h5n1-vaccine-induces-enhanced-systemic-as-well-as-mucosal-immunity-in-mice
#12
Weiping Cao, Jin Hyang Kim, Adrian J Reber, Mary Hoelscher, Jessica A Belser, Xiuhua Lu, Jacqueline M Katz, Shivaprakash Gangappa, Martin Plante, David S Burt, Suryaprakash Sambhara
Sporadic, yet frequent human infections with avian H5N1 influenza A viruses continue to pose a potential pandemic threat. Poor immunogenicity of unadjuvanted H5N1 vaccines warrants developing novel adjuvants and formulations as well as alternate delivery systems to improve their immunogenicity and efficacy. Here, we show that Protollin, a nasal adjuvant composed of Neisseria meningitides outer membrane proteins non-covalently linked to Shigella flexneri 2a lipopolysaccharide, is a potent nasal adjuvant for an inactivated split virion H5N1 clade 1 A/Viet Nam1203/2004 (A/VN/1203/04) vaccine in a mouse model...
June 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28490598/development-of-clade-specific-and-broadly-reactive-live-attenuated-influenza-virus-vaccines-against-rapidly-evolving-h5-subtype-viruses
#13
Kobporn Boonnak, Yumiko Matsuoka, Weijia Wang, Amorsolo L Suguitan, Zhongying Chen, Myeisha Paskel, Mariana Baz, Ian Moore, Hong Jin, Kanta Subbarao
We have developed pandemic live attenuated influenza vaccines (pLAIV) against clade 1 H5N1 viruses on an Ann Arbor cold-adapted (ca) backbone that induced long-term immune memory. In 2015, many human infections caused by a new clade (2.2.1.1) of goose/Guangdong (gs/GD) lineage H5N1 viruses were reported in Egypt that prompted updating of the H5N1 pLAIV. We explored two strategies to generate suitable pLAIVs: first to modify the hemagglutinin gene of a highly pathogenic wild-type (wt) clade 2.2.1.1 virus A/Egypt/N03434/2009 (Egy/09) (H5N1) with its unmodified neuraminidase (NA) gene; this virus was designated Egy/09 ca The second approach was to select a low pathogenicity avian influenza H5 virus that elicited antibodies that cross-reacted with a broad range of H5 viruses, including the Egypt H5N1 viruses and contained a novel NA subtype for humans...
May 10, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28469431/opportunities-and-challenges-of-adolescent-and-adult-vaccination-administration-within-pharmacies-in-the-united-states
#14
REVIEW
Jessica Y Islam, Joann F Gruber, Alexandre Lockhart, Manju Kunwar, Spencer Wilson, Sara B Smith, Noel T Brewer, Jennifer S Smith
Pharmacies have been endorsed as alternative vaccine delivery sites to improve vaccination rates through increased access to services. Our objective was to identify challenges and facilitators to adolescent and adult vaccination provision in pharmacy settings in the United States. We recruited 40 licensed pharmacists in states with different pharmacy vaccination laws. Eligible pharmacists previously administered or were currently administering human papillomavirus (HPV); tetanus, diphtheria, and pertussis (TDAP); or meningitis (meningococcal conjugate vaccine [MCV4]) vaccines to adolescents aged 9 to 17 years...
2017: Biomedical Informatics Insights
https://www.readbyqxmd.com/read/28468875/immune-escape-variants-of-h9n2-influenza-viruses-containing-deletions-at-the-haemagglutinin-receptor-binding-site-retain-fitness-in-vivo-and-display-enhanced-zoonotic-characteristics
#15
Thomas P Peacock, Donald J Benton, Joe James, Jean-Remy Sadeyen, Pengxiang Chang, Joshua E Sealy, Juliet E Bryant, Stephen R Martin, Holly Shelton, Wendy S Barclay, Munir Iqbal
H9N2 avian influenza viruses are enzootic in poultry across Asia and North Africa where they pose a threat to human health, both as zoonotic agents and as potential pandemic candidates. Poultry vaccination against H9N2 viruses has been employed in many regions, however vaccine effectiveness is frequently compromised due to antigenic drift arising from amino acid substitutions in the major influenza antigen, haemagglutinin (HA). Using selection with HA specific monoclonal antibodies, we previously identified H9N2 antibody escape mutants that contained deletions of amino acids in the 220 loop of the HA receptor binding sites (RBS)...
May 3, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28465097/challenges-in-conducting-post-authorisation-safety-studies-pass-a-vaccine-manufacturer-s-view
#16
Catherine Cohet, Dominique Rosillon, Corinne Willame, Francois Haguinet, Marie-Noëlle Marenne, Sandrine Fontaine, Hubert Buyse, Vincent Bauchau, Laurence Baril
Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates...
April 29, 2017: Vaccine
https://www.readbyqxmd.com/read/28463499/advancing-homogeneous-antimicrobial-glycoconjugate-vaccines
#17
Roberto Adamo
Since 2004, when the first synthetic glycoconjugate vaccine against the pneumonia and meningitis causing bacterium Haemophilus influenza type b (Hib) approved for human use in Cuba was reported, 34 million doses of the synthetic vaccine have been already distributed in several countries under the commercial name of Quimi-Hib. However, despite the success of this product, no other synthetic glycoconjugate vaccine has been licensed in the following 13 years. As well as avoiding the need to handle pathogens, synthetic glycoconjugates offer clear advantages in terms of product characterization and the possibility to understand the parameters influencing immunogenicity...
May 2, 2017: Accounts of Chemical Research
https://www.readbyqxmd.com/read/28457665/preclinical-and-clinical-demonstration-of-immunogenicity-by-mrna-vaccines-against-h10n8-and-h7n9-influenza-viruses
#18
Kapil Bahl, Joe J Senn, Olga Yuzhakov, Alex Bulychev, Luis A Brito, Kimberly J Hassett, Michael E Laska, Mike Smith, Örn Almarsson, James Thompson, Amilcar Mick Ribeiro, Mike Watson, Tal Zaks, Giuseppe Ciaramella
Recently, the World Health Organization confirmed 120 new human cases of avian H7N9 influenza in China resulting in 37 deaths, highlighting the concern for a potential pandemic and the need for an effective, safe, and high-speed vaccine production platform. Production speed and scale of mRNA-based vaccines make them ideally suited to impede potential pandemic threats. Here we show that lipid nanoparticle (LNP)-formulated, modified mRNA vaccines, encoding hemagglutinin (HA) proteins of H10N8 (A/Jiangxi-Donghu/346/2013) or H7N9 (A/Anhui/1/2013), generated rapid and robust immune responses in mice, ferrets, and nonhuman primates, as measured by hemagglutination inhibition (HAI) and microneutralization (MN) assays...
June 7, 2017: Molecular Therapy: the Journal of the American Society of Gene Therapy
https://www.readbyqxmd.com/read/28431812/potency-of-whole-virus-particle-and-split-virion-vaccines-using-dissolving-microneedle-against-challenges-of-h1n1-and-h5n1-influenza-viruses-in-mice
#19
Akihiro Nakatsukasa, Koji Kuruma, Masatoshi Okamatsu, Takahiro Hiono, Mizuho Suzuki, Keita Matsuno, Hiroshi Kida, Takayoshi Oyamada, Yoshihiro Sakoda
Transdermal vaccination using a microneedle (MN) confers enhanced immunity compared with subcutaneous (SC) vaccination. Here we developed a novel dissolving MN patch for the influenza vaccine. The potencies of split virion and whole virus particle (WVP) vaccines prepared from A/Puerto Rico/8/1934 (H1N1) and A/duck/Hokkaido/Vac-3/2007 (H5N1), respectively, were evaluated. MN vaccination induced higher neutralizing antibody responses than SC vaccination in mice. Moreover, MN vaccination with a lower dose of antigens conferred protective immunity against lethal challenges of influenza viruses than SC vaccination in mice...
April 18, 2017: Vaccine
https://www.readbyqxmd.com/read/28429728/a-formulated-tlr7-8-agonist-is-a-flexible-highly-potent-and-effective-adjuvant-for-pandemic-influenza-vaccines
#20
Neal Van Hoeven, Christopher B Fox, Brian Granger, Tara Evers, Sharvari W Joshi, Ghislain I Nana, Sarah C Evans, Susan Lin, Hong Liang, Li Liang, Rie Nakajima, Philip L Felgner, Richard A Bowen, Nicole Marlenee, Airn Hartwig, Susan L Baldwin, Rhea N Coler, Mark Tomai, James Elvecrog, Steven G Reed, Darrick Carter
Since 1997, highly pathogenic avian influenza viruses of the H5N1 subtype have been transmitted from avian hosts to humans. The severity of H5N1 infection in humans, as well as the sporadic nature of H5N1 outbreaks, both geographically and temporally, make generation of an effective vaccine a global public health priority. An effective H5N1 vaccine must ultimately provide protection against viruses from diverse clades. Toll-like receptor (TLR) agonist adjuvant formulations have a demonstrated ability to broaden H5N1 vaccine responses in pre-clinical models...
April 21, 2017: Scientific Reports
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