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Fully Human Immunoglobulin G From Transchromosomic Bovines Treats Nonhuman Primates Infected With Ebola Virus Makona Isolate.
Luke, Thomas; Bennett, Richard S; Gerhardt, Dawn M; Burdette, Tracey; Postnikova, Elena; Mazur, Steven; Honko, Anna N; Oberlander, Nicholas; Byrum, Russell; Ragland, Dan; St Claire, Marisa; Janosko, Krisztina B; Smith, Gale; Glenn, Gregory; Hooper, Jay; Dye, John; Pal, Subhamoy; Bishop-Lilly, Kimberly A; Hamilton, Theron; Frey, Kenneth; Bollinger, Laura; Wada, Jiro; Wu, Hua; Jiao, Jin-An; Olinger, Gene G; Gunn, Bronwyn; Alter, Galit; Khurana, Surender; Hensley, Lisa E; Sullivan, Eddie; Jahrling, Peter B.
Affiliation
  • Luke T; Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation for the Advancement of Military Medicine, Silver Spring, Maryland.
  • Bennett RS; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Gerhardt DM; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Burdette T; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Postnikova E; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Mazur S; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Honko AN; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Oberlander N; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Byrum R; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Ragland D; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • St Claire M; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Janosko KB; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Smith G; Novavax, Inc., Gaithersburg, Maryland.
  • Glenn G; Novavax, Inc., Gaithersburg, Maryland.
  • Hooper J; Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland.
  • Dye J; Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland.
  • Pal S; Viral and Rickettsial Diseases Department, Naval Medical Research Center, The Henry Jackson Foundation for the Advancement of Military Medicine, Silver Spring, Maryland.
  • Bishop-Lilly KA; Biological Defense Research Directorate, Naval Medical Research Center, Ft. Detrick, Maryland.
  • Hamilton T; Biological Defense Research Directorate, Naval Medical Research Center, Ft. Detrick, Maryland.
  • Frey K; Biological Defense Research Directorate, Naval Medical Research Center, Ft. Detrick, Maryland.
  • Bollinger L; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Wada J; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Wu H; SAB Biotherapeutics Inc., Sioux Falls, South Dakota.
  • Jiao JA; SAB Biotherapeutics Inc., Sioux Falls, South Dakota.
  • Olinger GG; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Gunn B; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard, Boston.
  • Alter G; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard, Boston.
  • Khurana S; Division of Viral Products, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Hensley LE; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
  • Sullivan E; SAB Biotherapeutics Inc., Sioux Falls, South Dakota.
  • Jahrling PB; Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, Maryland.
J Infect Dis ; 218(suppl_5): S636-S648, 2018 11 22.
Article in En | MEDLINE | ID: mdl-30010950
ABSTRACT
Transchromosomic bovines (Tc-bovines) adaptively produce fully human polyclonal immunoglobulin (Ig)G antibodies after exposure to immunogenic antigen(s). The National Interagency Confederation for Biological Research and collaborators rapidly produced and then evaluated anti-Ebola virus IgG immunoglobulins (collectively termed SAB-139) purified from Tc-bovine plasma after sequential hyperimmunization with an Ebola virus Makona isolate glycoprotein nanoparticle vaccine. SAB-139 was characterized by several in vitro production, research, and clinical level assays using wild-type Makona-C05 or recombinant virus/antigens from different Ebola virus variants. SAB-139 potently activates natural killer cells, monocytes, and peripheral blood mononuclear cells and has high-binding avidity demonstrated by surface plasmon resonance. SAB-139 has similar concentrations of galactose-α-1,3-galactose carbohydrates compared with human-derived intravenous Ig, and the IgG1 subclass antibody is predominant. All rhesus macaques infected with Ebola virus/H.sapiens-tc/GIN/2014/Makona-C05 and treated with sufficient SAB-139 at 1 day (n = 6) or 3 days (n = 6) postinfection survived versus 0% of controls. This study demonstrates that Tc-bovines can produce pathogen-specific human Ig to prevent and/or treat patients when an emerging infectious disease either threatens to or becomes an epidemic.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Immunoglobulin G / Hemorrhagic Fever, Ebola / Ebolavirus / Antibodies, Viral Limits: Animals / Female / Humans / Male Language: En Journal: J Infect Dis Year: 2018 Type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Immunoglobulin G / Hemorrhagic Fever, Ebola / Ebolavirus / Antibodies, Viral Limits: Animals / Female / Humans / Male Language: En Journal: J Infect Dis Year: 2018 Type: Article