Experimental Ebola blood therapy trial gets under way
Blood taken from survivors of Ebola could help protect others who contract the deadly disease, as part of a new trial in Liberia.
The Ebola convalescent plasma (ECP) clinical trial will see Ebola survivors donate plasma at the ELWA Hospital 2 unit in Monrovia, Liberia, using a process called plasmapheresis.
The trial is co-ordinated by a number of partners, including contract research organisation ClinicalRM, and is being funded by the Bill & Melinda Gates Foundation.
The new trial is necessary because of the lack of existing treatments and vaccines against the disease, which is still not under control in the West Africa countries of Sierre Leone, Guinea and Liberia.
The trial is based on the idea that anti-Ebola antibodies in the survivors’ plasma can be transferred and will help anyone infected to fight off the disease much more effectively.
Donated hi-tech equipment will allow survivors to be tested to ensure they are cured of Ebola (EVD) and are not infected with other diseases such as HIV-1, HIV-2, hepatitis B, hepatitis C and syphilis. The trial will also use pathogen inactivation technology, which will substantially reduce the risk of any transfusion-transmitted infection from blood components.
The trial will focus on the safety and efficacy of the procedure, which could be expanded if it proves successful.
“We are pleased to have been able to begin the study and will now start to learn, within the context of a closely monitored clinical study, the therapeutic potential that ECP has on patients suffering from this life-threatening disease,” said Dr. Jerry Brown, head of the ELWA 2 unit in Monrovia, Liberia and lead for the clinical trial.
“Most critically, we will now have the human and technical infrastructure to combat Ebola and other diseases in the future.” Dr. Brown was highlighted in TIME Magazine’s Person of the Year 2014 “The Ebola Fighters” as one of the leaders fighting the epidemic.
“At a time when there is no specific therapy for Ebola, this trial is truly unique in that it serves to empower survivors of EVD with the ability to fight back through the donation of plasma that could potentially save someone’s life,” said William A. Fischer II, MD, Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine, the University of North Carolina School of Medicine.
A range of lab capabilities have been added to the hospital system allowing for real time electrolyte analysis, allowing clinical teams to make informed and rapid treatment decisions.
“A number of Liberian health care workers have been trained to conduct plasmapheresis and how to implement proper research techniques,” said David Hoover, MD, Ebola Program Director, ClinicalRM. “This will empower local health care systems to become more self-sufficient and better serve their patients during this current epidemic as well as in the future.”
The Gates Foundation is funding plasma donation centres in Guinea and Nigeria to help patients across the affected region. It includes the research, scientific and technical involvement and expertise of academic, foundation and private sector partners.
The convalescent plasma will be collected through mobile donation units fully equipped with hi-tech plasma collection systems and pathogen inactivation blood system. Other organisations supporting the trial in Liberia include Safe Blood for Africa and Blood Centers of America. The donor, manufacturing, testing and transfusion information management system is being provided by Blood Bank Computer Systems, Inc.
There are numerous other efforts to develop new vaccines and therapies against the disease, which have all been accelerated, but cannot be developed as quickly as the plasma donation technique.
Last week, a trial of one of the vaccines, being developed by Merck and NewLink, was halted because of some patients complaining of joint pains in their hands and feet. The suspension of the trial is likely to be temporary, but investigators are being careful not to take shortcuts in safety, despite the urgency of the need.
GlaxoSmithKline and Janssen are both working on their own accelerated vaccine development programmes, but none are expected to be ready for widespread use before the middle of 2015.
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