Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18–64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials

[1]  D. Skowronski,et al.  Influenza Vaccine Effectiveness by A(H3N2) Phylogenetic Subcluster and Prior Vaccination History: 2016–2017 and 2017–2018 Epidemics in Canada , 2020, The Journal of infectious diseases.

[2]  Manish M Patel,et al.  Effects of Influenza Vaccination in the United States during the 2018-2019 Influenza Season. , 2020, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[3]  Gavin J. D. Smith,et al.  Divergent evolutionary trajectories of influenza B viruses underlie their contemporaneous epidemic activity , 2019, Proceedings of the National Academy of Sciences.

[4]  Donald J. Trump.  Executive Order 13887: Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health , 2019 .

[5]  A. D. De Groot,et al.  Highly conserved influenza T cell epitopes induce broadly protective immunity. , 2019, Vaccine.

[6]  C. Reed,et al.  Waning of influenza vaccine protection: Exploring the trade-offs of changes in vaccination timing among older adults. , 2019, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[7]  I. Barr,et al.  A Tale of Two Mutations: Beginning to Understand the Problems with Egg-Based Influenza Vaccines? , 2019, Cell host & microbe.

[8]  B. Guy,et al.  Immunogenicity and safety of a quadrivalent plant-derived virus like particle influenza vaccine candidate—Two randomized Phase II clinical trials in 18 to 49 and ≥50 years old adults , 2019, PloS one.

[9]  I. Rouiller,et al.  Plant-derived virus-like particle vaccines drive cross-presentation of influenza A hemagglutinin peptides by human monocyte-derived macrophages , 2019, npj Vaccines.

[10]  A. Sant.  The Way Forward: Potentiating Protective Immunity to Novel and Pandemic Influenza Through Engagement of Memory CD4 T Cells , 2019, The Journal of infectious diseases.

[11]  A. Melidou,et al.  Co-circulation of influenza A(H1N1)pdm09 and influenza A(H3N2) viruses, World Health Organization (WHO) European Region, October 2018 to February 2019 , 2019, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.

[12]  A. Monto,et al.  Effects of Influenza Vaccination in the United States during the 2017-2018 Influenza Season. , 2019, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[13]  C. Krawczyk,et al.  Characterization of the innate stimulatory capacity of plant-derived virus-like particles bearing influenza hemagglutinin. , 2018, Vaccine.

[14]  D. Skowronski,et al.  Vaccine Effectiveness Against Lineage-matched and -mismatched Influenza B Viruses Across 8 Seasons in Canada, 2010–2011 to 2017–2018 , 2018, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[15]  M. Kulldorff,et al.  Intra-season Waning of Influenza Vaccine Effectiveness. , 2018, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[16]  G. Poland.  Influenza vaccine failure: failure to protect or failure to understand? , 2018, Expert review of vaccines.

[17]  M. Valenciano,et al.  Interim 2017/18 influenza seasonal vaccine effectiveness: combined results from five European studies , 2018, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.

[18]  A. Gordon,et al.  The Burden of Influenza: a Complex Problem , 2018, Current Epidemiology Reports.

[19]  D. Skowronski,et al.  Early season co-circulation of influenza A(H3N2) and B(Yamagata): interim estimates of 2017/18 vaccine effectiveness, Canada, January 2018 , 2018, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.

[20]  B. Yassine-Diab,et al.  Humoral and cell-mediated immune responses to H5N1 plant-made virus-like particle vaccine are differentially impacted by alum and GLA-SE adjuvants in a Phase 2 clinical trial , 2018, npj Vaccines.

[21]  S. Pillet,et al.  The establishment of surrogates and correlates of protection: Useful tools for the licensure of effective influenza vaccines? , 2018, Human vaccines & immunotherapeutics.

[22]  J. Gilbert.  Seasonal and pandemic influenza: global fatigue versus global preparedness. , 2017, The Lancet. Respiratory medicine.

[23]  S. Pillet,et al.  A Single Intramuscular Dose of a Plant-Made Virus-Like Particle Vaccine Elicits a Balanced Humoral and Cellular Response and Protects Young and Aged Mice from Influenza H1N1 Virus Challenge despite a Modest/Absent Humoral Response , 2017, Clinical and Vaccine Immunology.

[24]  E. Montomoli,et al.  Egg-Independent Influenza Vaccines and Vaccine Candidates , 2017, Vaccines.

[25]  Cheng-Ying Wu,et al.  Plant-made virus-like particle vaccines bearing the hemagglutinin of either seasonal (H1) or avian (H5) influenza have distinct patterns of interaction with human immune cells in vitro. , 2017, Vaccine.

[26]  O. González-Ortega,et al.  Plant-Made Vaccines in the Fight Against Cancer. , 2017, Trends in biotechnology.

[27]  B. Flannery,et al.  Intraseason Waning of Influenza Vaccine Protection: Evidence From the US Influenza Vaccine Effectiveness Network, 2011–2012 Through 2014–2015 , 2016, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[28]  Michael A Proschan,et al.  A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection. , 2016, The New England journal of medicine.

[29]  George P. Lomonossoff,et al.  Plant-produced biopharmaceuticals: A case of technical developments driving clinical deployment , 2016, Science.

[30]  Michael G Hudgens,et al.  Invited Commentary: Beware the Test-Negative Design. , 2016, American journal of epidemiology.

[31]  B. Yassine-Diab,et al.  A plant-derived quadrivalent virus like particle influenza vaccine induces cross-reactive antibody and T cell response in healthy adults. , 2016, Clinical immunology.

[32]  T. Mor,et al.  Molecular pharming’s foot in the FDA’s door: Protalix’s trailblazing story , 2015, Biotechnology Letters.

[33]  M. Cox,et al.  Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults , 2015, Therapeutic advances in vaccines.

[34]  P. Lerouge,et al.  Biochemical composition of haemagglutinin-based influenza virus-like particle vaccine produced by transient expression in tobacco plants. , 2015, Plant biotechnology journal.

[35]  G. Rimmelzwaan,et al.  Virus-specific T cells as correlate of (cross-)protective immunity against influenza. , 2015, Vaccine.

[36]  L. Vézina,et al.  Human antibody response to N-glycans present on plant-made influenza virus-like particle (VLP) vaccines. , 2014, Vaccine.

[37]  C. Diazgranados,et al.  Immunogenicity and safety of Fluzone(®) intradermal and high-dose influenza vaccines in older adults ≥65 years of age: a randomized, controlled, phase II trial. , 2014, Vaccine.

[38]  A. Waltenberger,et al.  Egg- or cell culture-derived hemagglutinin mutations impair virus stability and antigen content of inactivated influenza vaccines. , 2014, Biotechnology journal.

[39]  J. Oxford,et al.  Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans , 2012, Nature Medicine.

[40]  M. Kieny,et al.  WHO initiative to increase global and equitable access to influenza vaccine in the event of a pandemic: supporting developing country production capacity through technology transfer. , 2011, Vaccine.

[41]  T. Vesikari,et al.  Clinical efficacy of cell culture–derived and egg‐derived inactivated subunit influenza vaccines in healthy adults. , 2010, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[42]  Brian J Ward,et al.  Influenza virus-like particles produced by transient expression in Nicotiana benthamiana induce a protective immune response against a lethal viral challenge in mice. , 2008, Plant biotechnology journal.