State-of-the-Art Workshops on Medical Countermeasures Potentially Available for Human Use Following Accidental Exposures to Ebola Virus

被引:10
作者
Jahrling, Peter B. [1 ]
Hensley, Lisa E. [1 ]
Barrett, Kevin [2 ]
Lane, Henry Clifford [2 ]
Davey, Richard T. [2 ]
机构
[1] NIAID, Integrated Res Facil, Bethesda, MD 20892 USA
[2] NIAID, Div Clin Res, Bethesda, MD 20892 USA
基金
美国国家卫生研究院;
关键词
antisense; Ebola virus; medical countermeasures; monoclonal antibody; randomized clinical trial; siRNA; NONHUMAN-PRIMATES; HEMORRHAGIC-FEVER; POSTEXPOSURE PROTECTION; INFECTION; INHIBITOR; THERAPIES; MONKEYS; DISEASE;
D O I
10.1093/infdis/jiv115
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The ongoing outbreak of Ebola in West Africa has raised a general awareness that at present there are no Ebola-specific medical countermeasures (MCMs) with proven effectiveness. This paper recapitulates discussions held at the 6th International Filovirus Symposium in March 2014 as well as the subsequent design of a randomized clinical trial design for treating Ebola virus-infected patients evacuated from West Africa to the United States. A number of different drugs or biologics were critically reviewed and 3 different postexposure strategies were identified as being farthest along in development; passive immunotherapy with monoclonal antibodies, postexposure vaccination with constructs involving viral vectors (such as vesicular stomatitis virus), and antisense compounds directly targeting the viral genome such as modified phosphorodiamidate morpholino oligomer-based compounds and small interfering RNA products. At the time of the meetings, there were no investigational new drugs (INDs) in place for the candidate MCMs. Developers and sponsors of these candidate products were strongly encouraged to prepare pre-IND packets and submit pre-IND meeting requests to the Food and Drug Administration. Some of these investigational products have already been used under emergency authorizations to treat patients in Africa as well as patients evacuated to the United States or Western Europe.
引用
收藏
页码:S84 / S90
页数:7
相关论文
共 26 条
[1]  
(BRN) WBRN, 2014, CONS WHO BLOOD REG N, P1
[2]   Evaluating Ebola Therapies - The Case for RCTs [J].
Cox, Edward ;
Borio, Luciana ;
Temple, Robert .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (25) :2350-2351
[3]   Postexposure antibody prophylaxis protects nonhuman primates from filovirus disease [J].
Dye, John M. ;
Herbert, Andrew S. ;
Kuehne, Ana I. ;
Barth, James F. ;
Muhammad, Majidat A. ;
Zak, Samantha E. ;
Ortiz, Ramon A. ;
Prugar, Laura I. ;
Pratt, William D. .
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2012, 109 (13) :5034-5039
[4]   Effective post-exposure treatment of Ebola infection [J].
Feldmann, Heinz ;
Jones, Steven M. ;
Daddario-DiCaprio, Kathleen M. ;
Geisbert, Joan B. ;
Stroher, Ute ;
Grolla, Allen ;
Bray, Mike ;
Fritz, Elizabeth A. ;
Fernando, Lisa ;
Feldmann, Friederike ;
Hensley, Lisa E. ;
Geisbert, Thomas W. .
PLOS PATHOGENS, 2007, 3 (01) :54-61
[5]   Postexposure protection of non-human primates against a lethal Ebola virus challenge with RNA interference: a proof-of-concept study [J].
Geisbert, Thomas W. ;
Lee, Amy C. H. ;
Robbins, Marjorie ;
Geisbert, Joan B. ;
Honko, Anna N. ;
Sood, Vandana ;
Johnson, Joshua C. ;
de Jong, Susan ;
Tavakoli, Iran ;
Judge, Adam ;
Hensley, Lisa E. ;
MacLachlan, Ian .
LANCET, 2010, 375 (9729) :1896-1905
[6]   Treatment of Ebola virus infection with a recombinant inhibitor of factor Vila/tissue factor: a study in rhesus monkeys [J].
Geisbert, TW ;
Hensley, LE ;
Jahrling, PB ;
Larsen, T ;
Geisbert, JB ;
Paragas, J ;
Young, HA ;
Fredeking, TM ;
Rote, WE ;
Vlasuk, GP .
LANCET, 2003, 362 (9400) :1953-1958
[7]   A MODEL OF FEDERAL INTERAGENCY COOPERATION: THE NATIONAL INTERAGENCY CONFEDERATION FOR BIOLOGICAL RESEARCH [J].
Gilman, James K. ;
Wright, Mary ;
Lane, H. Clifford ;
Schoomaker, Eric B. .
BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE, 2014, 12 (03) :144-150
[8]   Recombinant human activated protein C for the postexposure treatment of Ebola hemorrhagic fever [J].
Hensley, Lisa E. ;
Stevens, Edward L. ;
Yan, S. Betty ;
Geisbert, Joan B. ;
Macias, William L. ;
Larsen, Tom ;
Daddario-DiCaprio, Kathleen M. ;
Cassell, Gail H. ;
Jahrling, Peter B. ;
Geisbert, Thomas W. .
JOURNAL OF INFECTIOUS DISEASES, 2007, 196 :S390-S399
[9]   Evaluation of immune globulin and recombinant interferon-α2b for treatment of experimental Ebola virus infections [J].
Jahrling, PB ;
Geisbert, TW ;
Geisbert, JB ;
Swearengen, JR ;
Bray, M ;
Jaax, NK ;
Huggins, JW ;
LeDuc, JW ;
Peters, CJ .
JOURNAL OF INFECTIOUS DISEASES, 1999, 179 :S224-S234
[10]  
Jahrling PB, 1996, ARCH VIROL, P135