American researchers have started the first-in-human trial evaluating an experimental treatment for Ebola virus disease, the National Institute of Health (NIH) Clinical Centre, the nation’s largest hospital for clinical research, has said.
The Phase I clinical trial is examining the safety and tolerability of a single monoclonal antibody called mAb114, which was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), under NIH, and their collaborators. Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60.
The trial will not expose participants to Ebola virus.
Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain and hemorrhage (severe bleeding). It was first discovered in humans in 1976 in the Democratic Republic of the Congo (DRC) and has caused periodic cases and outbreaks in several African countries since then.
According to WHO, the largest outbreak, which occurred in West Africa from 2014 to 2016, caused more than 28,600 infections and more than 11,300 deaths. In May 2018, the DRC reported a new Ebola outbreak.
There are currently no licensed treatments available for Ebola virus disease, although multiple experimental therapies are being developed.
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 NIAID Director Anthony Fauci.
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 Kikwit, a city in the DRC.
Nancy Sullivan, chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC), and her team, in collaboration with researchers from the National Institute of Biomedical Research (INRB) in the DRC and the Institute for Biomedical Research in Switzerland, discovered that the survivor retained antibodies against Ebola 11 years after infection.
They isolated the antibodies and tested the most favorable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising.
The researchers illustrated that 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.
Martin Gaudinski, medical director in the VRC’s Clinical Trials Programme, is the principal investigator of the new trial.
The first three participants will receive a five mg per kg intravenous infusion of mAb114 for 30 minutes.
The study monitoring 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 change.
