Washington, US researchers have started the first-in-human trial evaluating an experimental treatment for Ebola virus disease, the National Institutes of Health (NIH) Clinical Centre said in a statement.
The Phase 1 clinical trial, named as VRC 608, is examining the safety and tolerability of a single monoclonal antibody called mAb114, developed from an Ebola survivor.
Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60. The trial will not expose participants to Ebola virus.
“We hope this trial will establish the safety of this experimental treatment for Ebola virus disease — an important first step in a larger evaluation process,” said Anthony S. Fauci, Director at the National Institute of Allergy and Infectious Diseases (NIAID) in Maryland, US
“Ebola is highly lethal, and reports of another outbreak in the DRC (the Democratic Republic of Congo) remind us that we urgently need Ebola treatments.
“This study adds to NIAID efforts in conducting scientifically and ethically sound biomedical research to develop countermeasures against Ebola virus disease,” Fauci added.
MAb114 is a monoclonal antibody — a protein that binds to a single target on a pathogen — isolated from a human survivor of the 1995 Ebola outbreak in a city in the DRC.
Researchers from the NIAID discovered that survivor retained antibodies against Ebola 11 years after infection.
They isolated the antibodies and tested the most favourable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising.
The researchers illustrated that MAb114 binds to the hard-to-reach core of the Ebola virus surface protein and blocks the protein’s interaction with its receptor on human cells.
A single dose of mAb114 protected non-human primates days after lethal Ebola virus infection.
In the trial, which would be fully enrolled by July 2018, the first three participants will receive a 5 milligram per kilogram intravenous infusion of mAb114 for 30 minutes.
The team will evaluate safety data to determine if the remaining participants can receive higher doses (25 mg/kg and 50 mg/kg).
Participants will have blood taken before and after the infusion and will bring a diary card home to record their temperature and any symptoms for three days.
Participants will visit the clinic approximately 14 times over six months to have their blood drawn to see if mAb114 is detectable and to be checked for any health changes, the report said.
Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain and haemorrhage (severe bleeding).
First discovered in humans in 1976 in the DRC, the largest outbreak, occurred in West Africa from 2014 to 2016. It caused more than 28,600 infections and more than 11,300 deaths, according to the World Health Organization.
In May 2018, the DRC reported new Ebola outbreak. While there are no licensed treatments available for Ebola virus disease yet, multiple experimental therapies are being developed.