Twenty healthy volunteers will next week enter a 48-week trial for a US-developed vaccine against the deadly Ebola virus. The trial has been moved forward due to the current outbreak, but the first results are unlikely before the year end.
The vaccine, which is aimed against two of the most common strains of Ebola, should replicate animal studies, in which it stimulated an immune response, producing antibodies, but not infecting the patient. Similar tests of the medicine, co-developed by pharmaceuticals megalith GlaxoSmithKline (GSK), may begin on UK volunteers next month.
“I have been fooled enough in my many years of experience in infectious disease vaccinology that you really can’t predict what you might see,” said Anthony Fauci, the director of the state-run National Institute of Allergy and Infectious Diseases (NIAID), which will be conducting the tests, when asked about the predicted efficaciousness of the drug.
“We expect to be able to report initial safety and immunogenicity data from this study by the end of this calendar year.”
But the researcher also sought to allay concerns that the vaccine had been rushed to the human testing stage, without proper procedures.
“The worst thing you’d want to do is let something widely out before you’ve even tested a modicum of safety. That would violate scientific principles and, in many respects, even ethical principles,” Fauci told the media in a scheduled call, while admitting that the trials were “an all-hands-on-deck response."
A British group has pledged $4.6 million to accelerate the trial period, and GSK says it can have about 10,000 doses ready by the end of this year. It is, however, unlikely that the drug will be approved by the authorities until a wider trial is conducted.
Another vaccine engineered by the Iowa-based NewLink Genetics will also go on trial in autumn.
Researchers of both will hope that the vaccines will prove more effective than the experimental ZMapp, which has provided mixed results so far, with two patients dying and two recovering out of those who have received it, and gone through the course of the disease.
The World Health Organization believes that as many as 20,000 people may die as a result of the two separate epidemics in western and central Africa, which may have begun as early as last year.
The current death toll stands at over 1,500, though is likely much higher, as many patients may have had no access to formal healthcare, or may have been hidden by relatives avoiding stigma.
Fauci emphasized that much as a vaccine will alleviate the crisis, the current epidemic, in which more than 200 doctors and nurses have fallen ill, is as much a result of poor sanitary practices, as of the dangers of the disease, which kills more than half of all patients.
Among the most damaging, is the lack of gloves and masks among doctors, who become hosts for the disease, and traditional burial practices, which can create initiate a branching network of infection if mourners touch the decomposing, infectious bodies, as is customary.
“We know that the spread of Ebola infection can be prevented through public health measures, including good infection control practices, patient isolation, contact tracing, quarantine, and the correct use of personal protective equipment. In the current situation in West Africa, these validated public health measures must be the main focus of current efforts to contain the disease,” warned Fauci.