The clinical trial was first announced during the 2018 outbreak in the Democratic Republic of Congo (DRC). The World Health Organization (WHO) announced on July 24th that this outbreak is officially over, but called for international efforts to stop outbreaks in DRC.
The treatment clinical trial is still in Phase I, where it is set to examine the safety and tolerability of a single monoclonal antibody (mAb), known as mAb114. The National Institute of Allergy and Infectious Diseases (NIAID) told us, “Establishing the safety of this experimental treatment through a Phase I trial is the first step in a larger evaluation process.”
“The Phase I trial is examining a single monoclonal antibody, as opposed to multiple monoclonal antibodies or a cocktail treatment combining multiple monoclonal antibodies,” NIAID spokesperson continued.
The particular antibodies in this trial are taken from an Ebola survivor from 1995 in Kikwit.
Monoclonal antibodies are proteins that bind to a target on a pathogen. This particular antibody is able to bind to the core of the Ebola virus surface protein, according to a report on mAb114.
The largest Ebola outbreak occurred in 2014-2016, in West Africa. In 2018, an Ebola outbreak in the Democratic Republic of Congo showed the NIAID that “this virus will continue to impact human populations, supporting the need for clinical studies aimed at making therapeutics available in future outbreaks.”
Ebola is often fatal and caused more than 11,300 deaths from 2014-2016, with a total of 28,600 cases according to WHO. It is transmitted through the bodily fluids of an infected animal or individual.
There are currently no licensed treatments available for Ebola, palliative care has been the course of treatment for the fatal disease, including blood pressure stabilizing drugs, oxygen, and electrolyte replacement therapy according to WHO.
According to the NIAID the Phase I clinical trial is currently enrolling 18-30 healthy volunteers between the ages of 18-60, with an aim to complete enrollment by early fall.