Abstract
We evaluated MEDI8852, a human IgG1 monoclonal antibody that binds a highly conserved influenza A hemagglutinin stalk epitope, in outpatients with uncomplicated influenza A infection. A total of 126 subjects aged 18 to 65 years were enrolled during the 2015 to 2016 Northern and 2016 Southern Hemisphere seasons. Subjects with symptom onset ≤5 days before dosing were randomized to four cohorts: 750 mg (cohort 1) or 3,000 mg (cohort 2) MEDI8852 (single intravenous infusion) plus 75 mg oseltamivir, placebo plus 75 mg oseltamivir (cohort 3), and 3,000 mg MEDI8852 alone (cohort 4). Subjects were monitored through day 10 for solicited influenza symptoms, day 28 for adverse events (AEs), and day 101 for serious AEs and AEs of special interest. Nasopharyngeal samples were collected through day 7 for confirmation of influenza A infection, viral shedding, and oseltamivir and MEDI8852 susceptibility. Slightly more AEs were reported in subjects receiving MEDI8852 (cohorts 1, 2, and 4 combined: 39/93, 41.9%) than oseltamivir only (cohort 3: 10/32, 31.3%). Most AEs were mild or moderate. The most common AE was bronchitis (11/93, 11.8%; 1/32, 3.1%). The median (range) decrease in viral shedding (log10 virus genome copies/ml) was similar betwee...Continue Reading
References
Sep 26, 1997·The New England Journal of Medicine·F G HaydenK Wightman
Mar 4, 2000·JAMA : the Journal of the American Medical Association·J J TreanorR G Mills
Jun 24, 2000·Lancet·K G NicholsonP Ward
Dec 21, 2002·The Journal of Antimicrobial Chemotherapy·F Y AokiUNKNOWN IMPACT Study Group
Aug 28, 2007·Veterinary Microbiology·Amy L VincentJuergen A Richt
Oct 3, 2009·Vaccine·Pierre J T De VilliersUNKNOWN LAIV Elderly Study Trial Network
Feb 12, 2011·Vaccine·Phillip C GaugerJames A Roth
Jul 31, 2012·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Janice K LouieTimothy M Uyeki
Aug 30, 2013·Science Translational Medicine·Surender KhuranaHana Golding
Sep 2, 2015·Human Vaccines & Immunotherapeutics·Po-Ying Chan-Hui, Kristine M Swiderek
Feb 14, 2016·Antiviral Research·Jennifer L McKimm-Breschkin, Alicia M Fry
May 22, 2016·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Shobana Balasingam, Annelies Wilder-Smith
Jul 28, 2016·Cell·Nicole L KallewaardJohn J Skehel
Oct 19, 2016·Trends in Microbiology·Boopathy RamakrishnanRam Sasisekharan
Mar 3, 2017·Bulletin of the World Health Organization·Erin SparrowSiranda Torvaldsen
Jun 22, 2017·The Journal of Infectious Diseases·Catharine I PaulesKanta Subbarao
Jun 24, 2017·Clinical Pharmacokinetics·Rong DengWilliam D Hanley
Aug 29, 2017·Biologicals : Journal of the International Association of Biological Standardization·Raburn M MalloryLeo Tseng
Citations
Jun 21, 2019·Vaccines·Erasmus KoteyMunir Iqbal
Dec 31, 2019·Pediatric Transplantation·Annabelle de St Maurice, Natasha Halasa
Mar 7, 2020·Vaccines·Deimante LukosaityteMunir Iqbal
Jun 28, 2020·The Journal of Immunology : Official Journal of the American Association of Immunologists·Adam McNeeElma Tchilian
Jul 6, 2019·Frontiers in Microbiology·Mohammad Amin Behzadi, Victor H Leyva-Grado
Mar 9, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Tianyu NiuDanqing Song
Aug 2, 2019·Current Drug Targets·Doreen Szollosi, Ashley Bill
Dec 5, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Samuel K LaiRaymond J Pickles
Jul 20, 2019·Antiviral Research·Koen Sedeyn, Xavier Saelens
Dec 15, 2020·Advanced Drug Delivery Reviews·Carlos Cruz-TeranSamuel K Lai
Oct 26, 2020·Drug Discovery Today·Rick HeidaHenderik W Frijlink
Nov 22, 2020·Drug Discovery Today·Hershna Patel, Andreas Kukol
Dec 18, 2020·Expert Opinion on Pharmacotherapy·Qiao ZhangShuwen Liu
Apr 8, 2021·Nature Reviews. Microbiology·Tim FlerlageStacey Schultz-Cherry
Dec 6, 2020·Seminars in Immunology·Simone PecettaAnja Seubert
May 24, 2021·Drug Discovery Today·Zeenat A ShyrWei Zheng
Jun 5, 2021·Cell·Davide CortiDavid Veesler
Sep 27, 2021·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Philippe BuchyEskild Petersen