id author title date pages extension mime words sentences flesch summary cache txt cord-333882-zrdsr3nh Beigel, John H Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study 2018-04-30 .txt text/plain 4886 236 49 title: Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study We report the safety of a fully human polyclonal IgG antibody (SAB-301) produced from the hyperimmune plasma of transchromosomic cattle immunised with a MERS coronavirus vaccine. We recruited healthy participants aged 18–60 years who had normal laboratory parameters at enrolment, a body-mass index of 19–32 kg/m2, and a creatinine clearance of 70 mL/min or more, and who did not have any chronic medical problems that required daily oral medications, a positive rheumatoid factor (≥15 IU/mL), IgA deficiency (<7 mg/dL), or history of allergy to intravenous immunoglobulin or human blood products. One novel alternative method of manufacturing neutralising intravenous antibodies of consistently high affinity and avidity is to use the hyperimmune plasma of transchromosomic cattle, which produce highly potent and antigen-specific, fully human polyclonal IgG de novo, and which mount a robust antibody immune response after vaccination. SAB-301 is a novel anti-MERS-CoV intravenous immunoglobulin manufactured from the hyperimmune plasma of transchromosomic cattle that produce fully human polyclonal IgG. ./cache/cord-333882-zrdsr3nh.txt ./txt/cord-333882-zrdsr3nh.txt