Research

SCIENCE By Kai Kupferschmidt                                                                       March 11, 2015

Researchers in Sierra Leone today started a new phase II trial of an experimental drug in Ebola patients. The first participant received an injection of the therapeutic, called TKM-Ebola, this morning at an Ebola treatment unit in Kerry Town. The trial may expand to other sites; the study team hopes to have an answer fast so that it can either move on to another drug or start a phase III study of TKM-Ebola.

Produced by Tekmira Pharmaceuticals in Burnaby, Canada, TKM-Ebola is made of synthetic, small interfering RNAs packaged into lipid nanoparticles. The RNAs target three of Ebola’s seven genes, blocking the virus’s replication. TKM-Ebola has been shown to work well in monkeys; the efficacy trial in humans is only starting now because there was not enough of the drug available earlier. Also, the RNAs have been adapted to the strain circulating at the moment.

The study does not have a placebo arm; all patients at the trial site are eligible for the drug, and researchers hope to determine whether it works by comparing them with patients treated elsewhere.

Researchers are scrambling to start trials before the outbreak fades, but establishing faith in vaccines will take time

AL JAZEERA AMERICA  by Amy Maxmen                       March 11, 2015

FREETOWN, Sierra Leone — Since Ebola hit this coastal city last summer, nurses at Connaught Hospital have put their lives on the line by working with patients at risk of the deadly disease. Now researchers aim to recruit them as well as ambulance drivers and other hospital staff as subjects in one of the largest Ebola vaccine trials to date.

But just a few weeks before the trial begins enrollment, many health care workers are voicing discomfort about the shot. “It would be really good to have a vaccine, but we’re scared because it’s new,” said Kadiatu Nubieu, a nurse at Connaught.

A CDC study suggests that the Ebola virus may still be able to cause disease a week after a person infected with the virus has died.

CDC  EMERGING INFECTIOUSNESS DISEASE JOURNAL        March, 2015
Abstract

http://wwwnc.cdc.gov/eid/article/21/5/15-0041_article

FORBES   by   David Kroll                                                                                          March 1, 2015

The widely-discussed antibody cocktail, ZMapp, is finally going to be tested under standardized, controlled conditions for its safety and efficacy in Ebola virus disease-infected patients in Liberia and, potentially, the United States.

Late Friday, the NIH National Institute of Allergy and Infectious Disease (NIAID) announced the launch of a randomized trial in up to 200 patient volunteers with confirmed Ebola virus infections.

The two-arm study will compare supportive standard of care with or without three intravenous infusions of ZMapp spaced three days apart. This is the same dosing regimen published in Nature that protected 18 of 18 monkeys when given up to five days after experimental infection.

LeafBio, the commercial arm of San Diego-based Mapp Biopharmaceutical, announced concomitantly that the FDA had approved their IND for this trial. The three antibodies that comprise ZMapp target both distinct and overlapping parts of the Ebola virus glycoprotein (GP) that it uses to infect humans.