US begins testing Ebola treatment in early-stage trial
Washington, May 27: 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.
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Dalit couple beaten, made to wear garlands of shoes in MP; 10 persons booked
Ashok Nagar (MP) (PTI): An elderly Dalit couple has been allegedly beaten up and made to wear garlands of shoes in Madhya Pradesh's Ashok Nagar district, police said on Sunday.
The couple's son had allegedly been involved in an eve-teasing incident, they said.
A case has been registered against 10 persons who were at large in connection with the incident of thrashing the couple which took place on Friday in Kilora village under Mungaoli police station limits, an official said.
The couple's son had been allegedly involved in eve-teasing the wife of one of the accused following which the Dalit family left the village, Mungaoli police station in-charge Gabbar Singh Gurjar said.
The couple came to the village recently, he said.
On Friday, the accused allegedly tied the 65-year-old man Dalit man and his wife aged 60 to a pole, beat them up and made them wear garlands of shoes, the official said.
Following a complaint by the victim woman, the police on Saturday registered a case against 10 persons under Indian Penal Code (IPC) sections 147 (rioting), 149 (unlawful assembly with common objective), 323 (voluntarily causing hurt), 294 (obscene act) and 506 (criminal intimidation) as well as provisions of the Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act, he said.
All the accused were absconding and efforts were on to trace them, the police added.
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