title: State-of-the-Art Workshops on Medical Countermeasures Potentially Available for Human Use Following Accidental Exposures to Ebola Virus.
abstract: 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.
authors.affiliation: Integrated Research Facility.
authors.forename: Peter B
authors.initials: PB
authors.lastname: Jahrling
authors.affiliation: Integrated Research Facility.
authors.forename: Lisa E
authors.initials: LE
authors.lastname: Hensley
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland.
authors.forename: Kevin
authors.initials: K
authors.lastname: Barrett
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland.
authors.forename: Henry Clifford
authors.initials: HC
authors.lastname: Lane
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland.
authors.forename: Richard T
authors.initials: RT
authors.lastname: Davey
mesh_terms: D000354:Africa, Western / Q000453:epidemiology; D000998:Antiviral Agents / Q000627:therapeutic use*; D004196:Disease Outbreaks; D018562:Disease Transmission, Infectious; D029043:Ebolavirus / Q000187:drug effects* / Q000276:immunology*; D019142:Hemorrhagic Fever, Ebola / Q000188:drug therapy / Q000453:epidemiology* / Q000276:immunology* / Q000821:virology; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014611:Vaccination / Q000379:methods
chemical_list: D000998:Antiviral Agents
keywords: Ebola virus; antisense; medical countermeasures; monoclonal antibody; randomized clinical trial; siRNA