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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New Delhi, Nov 21: In a strong defence of the Karnataka government's move to cancel ration cards, Chief Minister Siddaramaiah on Thursday clarified that only government employees and income tax payers are being weeded out from the Below Poverty Line (BPL) list, not eligible poor beneficiaries.
Talking to reporters, Siddaramaiah asserted that the cancellation is in line with the National Food Security Act, which explicitly bars government employees and income tax payers from receiving BPL ration cards.
He accused the Bharatiya Janata Party (BJP) of raising a politically motivated issue despite originally opposing the food security legislation.
"The rights of eligible ration card holders will be fully protected," the chief minister emphasised, dismissing opposition claims that the move was linked to fund constraints for implementing poll promises.
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The controversy stems from the Karnataka government's recent survey identifying 22.63 lakh BPL card-holders as ineligible. This move has triggered a political slugfest between the ruling Congress and the BJP.
Union Food Minister Pralhad Joshi claimed the central government had directed the state to clean the beneficiary lists. He alleged that the card cancellation was a strategy to avoid implementing the state's Gruha Lakshmi Yojana scheme.
Siddaramaiah hit back, reminding that the food security law was introduced during the Manmohan Singh government in 2013 to protect poor citizens' interests. He criticised the BJP for previously reducing food grain allocation from seven kg to five kg per beneficiary during B S Yediyurappa's tenure.
The chief minister categorically stated that there would be no compromise on the five poll guarantees and that sufficient funds were available for their implementation.
Siddaramaiah was in the national capital for the launch of Karnataka Cooperative Milk Producers' Federation Ltd's Nandini brands in Delhi. He also met Union Finance Minister Nirmala Sitharaman on the issue of farm loan.