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Volume 393, Issue 10174, Pages (March 2019)

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Presentation on theme: "Volume 393, Issue 10174, Pages (March 2019)"— Presentation transcript:

1 Volume 393, Issue 10174, Pages 889-898 (March 2019)
Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study  Martin R Gaudinski, MD, Emily E Coates, PhD, Laura Novik, MA, Alicia Widge, MD, Katherine V Houser, PhD, Eugeania Burch, MPH, LaSonji A Holman, FNP, Ingelise J Gordon, RN, Grace L Chen, MD, Cristina Carter, MD, Martha Nason, PhD, Sandra Sitar, MS, Galina Yamshchikov, MS, Nina Berkowitz, MPH, Charla Andrews, MS, Sandra Vazquez, MS, Carolyn Laurencot, PhD, John Misasi, MD, Frank Arnold, PhD, Kevin Carlton, MBA, Heather Lawlor, MS, Jason Gall, PhD, Robert T Bailer, PhD, Prof Adrian McDermott, PhD, Prof Edmund Capparelli, PharmD, Prof Richard A Koup, MD, Prof John R Mascola, MD, Prof Barney S Graham, MD, Prof Nancy J Sullivan, PhD, Prof Julie E Ledgerwood, DO Cynthia Starr Hendel, Sarah H. Plummer, Pamela Costner, Jamie Saunders, Floreliz Mendoza, Aba Mensima Eshun, Joseph Casazza, Abidemi Ola, William Whalen, Xiaolin Wang, Jennifer Cunningham, Olga Vasilenko, Catina R. Boyd, Olga Trofymenko, Maria Claudia Burgos Florez, Somia Hickman, Ro Shauna Rothwell, Iris R Pittman, Lam Ngan Le, Brenda D Larkin, Josephine H Cox, Preeti J Apte, Renunda T Hicks, Cora Trelles Cartagena, Pernell V Williams, LaShawn Requilman, Thuy Nguyen, Colin Tran, Sandra Vazquez, Michelle Conan-Cibotti, Judy Stein, Tatiana Beresnev Martin R Gaudinski, MD, Emily E Coates, PhD, Laura Novik, MA, Alicia Widge, MD, Katherine V Houser, PhD, Eugeania Burch, MPH, LaSonji A Holman, FNP, Ingelise J Gordon, RN, Grace L Chen, MD, Cristina Carter, MD, Martha Nason, PhD, Sandra Sitar, MS, Galina Yamshchikov, MS, Nina Berkowitz, MPH, Charla Andrews, MS, Sandra Vazquez, MS, Carolyn Laurencot, PhD, John Misasi, MD, Frank Arnold, PhD, Kevin Carlton, MBA, Heather Lawlor, MS, Jason Gall, PhD, Robert T Bailer, PhD, Prof Adrian McDermott, PhD, Prof Edmund Capparelli, PharmD, Prof Richard A Koup, MD, Prof John R Mascola, MD, Prof Barney S Graham, MD, Prof Nancy J Sullivan, PhD, Prof Julie E Ledgerwood, DO Cynthia Starr Hendel, Sarah H. Plummer, Pamela Costner, Jamie Saunders, Floreliz Mendoza, Aba Mensima Eshun, Joseph Casazza, Abidemi Ola, William Whalen, Xiaolin Wang, Jennifer Cunningham, Olga Vasilenko, Catina R. Boyd, Olga Trofymenko, Maria Claudia Burgos Florez, Somia Hickman, Ro Shauna Rothwell, Iris R Pittman, Lam Ngan Le, Brenda D Larkin, Josephine H Cox, Preeti J Apte, Renunda T Hicks, Cora Trelles Cartagena, Pernell V Williams, LaShawn Requilman, Thuy Nguyen, Colin Tran, Sandra Vazquez, Michelle Conan- Cibotti, Judy Stein, Tatiana Beresnev  The Lancet  Volume 393, Issue 10174, Pages (March 2019) DOI: /S (19) Copyright © 2019 Elsevier Ltd Terms and Conditions

2 Figure 1 Study profile *Withdrew because of time commitments (n=2), concern over potential risks (n=1), investigators unable to contact the individual (n=6), the study was full and no longer open to new participants (n=1), chose to participate in another US Vaccine Research Center study (n=2), and for other reasons (n=1). The Lancet  , DOI: ( /S (19) ) Copyright © 2019 Elsevier Ltd Terms and Conditions

3 Figure 2 mAb114 serum concentrations of participants by dose group with time (A) Serum concentrations of mAb114 for all individuals in each dose group and (B) mean mAb114 serum concentration by group, with SD. (C) mAb114 serum concentrations and coefficients of variation. Study drug was administered on day 0, and in panels A and B horizontal lines indicate the lower limit of detection (LOD) by enzyme-linked immunosorbent assay. Pharmacokinetic data in panel C are calculated using data from all participants with 28 days of pharmacokinetic data (n=13). Cmax=maximum serum concentration. Tmax=time to Cmax. The Lancet  , DOI: ( /S (19) ) Copyright © 2019 Elsevier Ltd Terms and Conditions


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