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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Trouble ‘Miyas’ everywhere only then they will leave Assam: Himanta Biswa Sarma
Says “Himanta Biswa Sarma, BJP are openly against them, we are saying it openly
New Delhi: Assam Chief Minister Himanta Biswa Sarma on Tuesday said that four to five lakh “Miya voters” would be removed from the electoral rolls in the state once the Special Intensive Revision (SIR) of voter lists is carried out. He also made a series of controversial remarks openly targeting the Miya community, a term commonly used in Assam in a derogatory sense to refer to Bengali-speaking Muslims.
Speaking to reporters on the sidelines of an official programme in Digboi in Tinsukia district, Sarma said it was his responsibility to create difficulties for the Miya community and claimed that both he and the BJP were “directly against Miyas”.
“Four to five lakh Miya votes will have to be deleted in Assam when the SIR happens,” Sarma said, adding that such voters “should ideally not be allowed to vote in Assam, but in Bangladesh”. He asserted that the government was ensuring that they would not be able to vote in the state.
The chief minister was responding to questions about notices issued to thousands of Bengali-speaking Muslims during the claims and objections phase of the ongoing Special Revision (SR) of electoral rolls in Assam. While the Election Commission is conducting SIR exercises in 12 states and Union Territories, Assam is currently undergoing an SR, which is usually meant for routine updates.
Calling the current SR “preliminary”, Sarma said that a full-fledged SIR in Assam would lead to large-scale deletion of Miya voters. He said he was unconcerned about criticism from opposition parties over the issue.
“Let the Congress abuse me as much as they want. My job is to make the Miya people suffer,” Sarma said. He claimed that complaints filed against members of the community were done on his instructions and that he had encouraged BJP workers to keep filing complaints.
“I have told people wherever possible they should fill Form 7 so that they have to run around a little and are troubled,” he said, adding that such actions were meant to send a message that “the Assamese people are still living”.
In remarks that drew further outrage, Sarma urged people to trouble members of the Miya community in everyday life, claiming that “only if they face troubles will they leave Assam”. He also accused the media of sympathising with the community and warned journalists against such coverage.
“So you all should also trouble, and you should not do news that sympathise with them. There will be love jihad in your own house.” He said.
The comments triggered reactions from opposition leaders. Raijor Dal president and MLA Akhil Gogoi said the people of Assam had not elected Sarma to keep one community under constant pressure. Congress leader Aman Wadud accused the chief minister of rendering the Constitution meaningless in the state, saying his remarks showed a complete disregard for constitutional values.
According to the draft electoral rolls published on December 27, Assam currently has 2.51 crore voters. Election officials said 4.78 lakh names were marked as deceased, 5.23 lakh as having shifted, and 53,619 duplicate entries were removed during the revision process. Authorities also claimed that verification had been completed for over 61 lakh households.
On January 25, six opposition parties the Congress, Raijor Dal, Assam Jatiya Parishad, CPI, CPI(M) and CPI(M-L) submitted a memorandum to the state’s chief electoral officer. They alleged widespread legal violations, political interference and selective targeting of genuine voters during the SR exercise, describing it as arbitrary, unlawful and unconstitutional.
