title: Immunologic monitoring during a phase 2a trial of the GNbAC1 antibody in patients with MS.
abstract: OBJECTIVE
  To monitor the systemic immune responses of patients with multiple sclerosis (MS) under treatment with GNbAC1, a monoclonal antibody against the envelope protein of the MS- associated retrovirus, during a phase 2a trial.
  
  
  METHODS
  We analyzed the composition of immune cell subsets and the activation level of monocytes by flow cytometry and the response against viral and vaccine antigens by ELISpot.
  
  
  RESULTS
  None of the endpoints measured revealed any immunosuppressive effect of the therapeutic antibody. Activation of monocytes slightly decreased during treatment as predicted by the hypothesized mechanism of action of GNbAC1.
  
  
  CONCLUSIONS
  These results support the conclusion that the antibody is safe for use in patients with MS.
  
  
  METHODS
  This study provides Class III evidence that in patients with MS GNbAC1 does not significantly affect several biomarkers of systemic immune response.
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Maria
authors.initials: M
authors.lastname: Zimmermann
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Nicholas S R
authors.initials: NS
authors.lastname: Sanderson
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Maria
authors.initials: M
authors.lastname: Rasenack
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Patrice H
authors.initials: PH
authors.lastname: Lalive
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Alois B
authors.initials: AB
authors.lastname: Lang
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Francois
authors.initials: F
authors.lastname: Curtin
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Raija L P
authors.initials: RL
authors.lastname: Lindberg
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.affiliation: Laboratory of Clinical Neuroimmunology (M.Z., N.S.R.S., M.R., R.L.P.L., L.K., T.D.), Department of Biomedicine, University Hospital Basel and University of Basel, Switzerland; Department of Neurology (M.R., L.K., T.D.), University Hospital Basel, Switzerland; Department of Neurosciences (P.H.L.), Division of Neurology, University Hospital Geneva and Faculty of Medicine, Geneva, Switzerland; and GeNeuro SA (A.B.L., F.C.), Plan-les-Ouates/Geneva, Switzerland.
authors.forename: Tobias
authors.initials: T
authors.lastname: Derfuss