Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults.

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  • Additional Information
    • Affiliation:
      Novavax, Inc. , Gaithersburg, Maryland, USA
      Institute of Virology , Philipps University of Marburg, Marburg, Germany
      German Center for Infection Research (DZIF) , Partner Site Gießen-Marburg-Langen, Marburg, Germany
      US Army Medical Research Institute of Infectious Diseases , Ft. Detrick, Maryland, USA
    • Abstract:
      Background: Ebola virus (EBOV) epidemics pose a major public health risk. There currently is no licensed human vaccine against EBOV. The safety and immunogenicity of a recombinant EBOV glycoprotein (GP) nanoparticle vaccine formulated with or without Matrix-M adjuvant were evaluated to support vaccine development.Methods: A phase 1, placebo-controlled, dose-escalation trial was conducted in 230 healthy adults to evaluate 4 EBOV GP antigen doses as single- or 2-dose regimens with or without adjuvant. Safety and immunogenicity were assessed through 1-year postdosing.Results: All EBOV GP vaccine formulations were well tolerated. Receipt of 2 doses of EBOV GP with adjuvant showed a rapid increase in anti-EBOV GP immunoglobulin G titers with peak titers observed on Day 35 representing 498- to 754-fold increases from baseline; no evidence of an antigen dose response was observed. Serum EBOV-neutralizing and binding antibodies using wild-type Zaire EBOV (ZEBOV) or pseudovirion assays were 3- to 9-fold higher among recipients of 2-dose EBOV GP with adjuvant, compared with placebo on Day 35, which persisted through 1 year.Conclusions: Ebola virus GP vaccine with Matrix-M adjuvant is well tolerated and elicits a robust and persistent immune response. These data suggest that further development of this candidate vaccine for prevention of EBOV disease is warranted.
    • Journal Subset:
      Biomedical; Editorial Board Reviewed; Peer Reviewed; USA
    • ISSN:
      0022-1899
    • MEDLINE Info:
      PMID: NLM31603201 NLM UID: 0413675
    • Publication Date:
      In Process
    • Publication Date:
      20200727
    • DOI:
      http://dx.doi.org/10.1093/infdis/jiz518
    • Accession Number:
      144727587
  • Citations
    • ABNT:
      FRIES, L. et al. Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults. Journal of Infectious Diseases, [s. l.], v. 222, n. 4, p. 572–582, 2020. DOI 10.1093/infdis/jiz518. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=144727587. Acesso em: 22 set. 2020.
    • AMA:
      Fries L, Cho I, Krähling V, et al. Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults. Journal of Infectious Diseases. 2020;222(4):572-582. doi:10.1093/infdis/jiz518
    • APA:
      Fries, L., Cho, I., Krähling, V., Fehling, S. K., Strecker, T., Becker, S., Hooper, J. W., Kwilas, S. A., Agrawal, S., Wen, J., Lewis, M., Fix, A., Thomas, N., Flyer, D., Smith, G., & Glenn, G. (2020). Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults. Journal of Infectious Diseases, 222(4), 572–582. https://doi.org/10.1093/infdis/jiz518
    • Chicago/Turabian: Author-Date:
      Fries, Louis, Iksung Cho, Verena Krähling, Sarah K Fehling, Thomas Strecker, Stephan Becker, Jay W Hooper, et al. 2020. “Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults.” Journal of Infectious Diseases 222 (4): 572–82. doi:10.1093/infdis/jiz518.
    • Harvard:
      Fries, L. et al. (2020) ‘Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults’, Journal of Infectious Diseases, 222(4), pp. 572–582. doi: 10.1093/infdis/jiz518.
    • Harvard: Australian:
      Fries, L, Cho, I, Krähling, V, Fehling, SK, Strecker, T, Becker, S, Hooper, JW, Kwilas, SA, Agrawal, S, Wen, J, Lewis, M, Fix, A, Thomas, N, Flyer, D, Smith, G & Glenn, G 2020, ‘Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults’, Journal of Infectious Diseases, vol. 222, no. 4, pp. 572–582, viewed 22 September 2020, .
    • MLA:
      Fries, Louis, et al. “Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults.” Journal of Infectious Diseases, vol. 222, no. 4, Aug. 2020, pp. 572–582. EBSCOhost, doi:10.1093/infdis/jiz518.
    • Chicago/Turabian: Humanities:
      Fries, Louis, Iksung Cho, Verena Krähling, Sarah K Fehling, Thomas Strecker, Stephan Becker, Jay W Hooper, et al. “Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults.” Journal of Infectious Diseases 222, no. 4 (August 15, 2020): 572–82. doi:10.1093/infdis/jiz518.
    • Vancouver/ICMJE:
      Fries L, Cho I, Krähling V, Fehling SK, Strecker T, Becker S, et al. Randomized, Blinded, Dose-Ranging Trial of an Ebola Virus Glycoprotein Nanoparticle Vaccine With Matrix-M Adjuvant in Healthy Adults. Journal of Infectious Diseases [Internet]. 2020 Aug 15 [cited 2020 Sep 22];222(4):572–82. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=144727587