Britons are to be the first in the world to test a new vaccine against the deadly ebola virus. Altogether 60 healthy volunteers will be given the vaccine next month in a trial led by Oxford University scientists. If the vaccine performs as well in humans as in monkeys, the trial will be extended to 80 people in The Gambia and in Mali.
The entire trial programme is being fast-tracked – subject to ethical approval – with the intention of using the vaccine in people at high risk in West Africa early next year.
Latest figures show that more than 1,550 people have died from the virus, with more than 3,000 confirmed cases – mostly in Guinea, Liberia and Sierra Leone.
It is the worst epidemic since the disease was first identified 38 years ago and the World Health Organization (WHO) predicts the outbreak will last for many months, affecting at least 20,000 people.
At present there is no vaccine to prevent the disease and no proven treatment.
The new vaccine contains a single ebola virus protein from the strain sweeping West Africa – anyone inoculated with it cannot develop the disease itself.
It is different from the experimental medicine ZMapp being used to treat William Pooley, the first Briton to contract the virus while working as a nurse at a remote health centre in Sierra Leone.
The 29-year-old is currently in isolation at London’s Royal Free Hospital.
The new trial will be led by Professor Adrian Hill, of the Jenner Institute at Oxford University, which has unprecedented experience in carrying out trials using similar types of vaccine.
He said the speed with which arrangements had been made was unparalleled in 20 years of experience in the field.
He said: ‘The tragic events unfolding in Africa demand an urgent response.
‘In recent years, similar investigational vaccines have safely immunised infants and adults against a range of diseases including malaria, HIV and Hepatitis C.
‘We, and all our partners on this project, are optimistic that this candidate vaccine may prove useful against ebola.’
The vaccine is being co-developed by the US National Institutes of Health (NIH) and pharmaceutical giant GlaxoSmithKline, along with a dual vaccine containing proteins against both West Africa and Sudan strains of ebola which is being trialled in the US.
The UK initiative is backed by a £2.8 million grant from the Wellcome Trust, the Medical Research Council and the UK Department for International Development.
The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials.
If the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.
Each set of volunteers will be split into groups of 20 that will receive different doses of the vaccine so researchers can evaluate the best dose to use in terms of both safety and activity.
It is being tested here and in West Africa to take account of differences between the different populations that might affect safety or immune response.
Prof Hill said successful completion of both stages of the trial in healthy volunteers could mean the vaccine is ready for large-scale use early in 2015.
He said results from studies in monkeys suggest a good safety profile from the single ebola virus protein, which produced high levels of antibodies and immune-boosting white blood cells.
As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with ebola.
The duration of response could only be discovered in ‘real-life’ situations but even if it only lasted a few months it would be enough to contain outbreaks, he said.
Dr Jeremy Farrar, director of the Wellcome Trust, said: ‘This epidemic has shown how difficult it can be to control ebola.
‘How useful drugs and vaccines might be in complementing existing public health interventions can only be assessed in epidemics.
‘The initial safety work we’re announcing today with our international partners will hopefully make that possible during this crisis and for inevitable future epidemics.’
Chief Medical Officer, Dame Sally Davies said she was pleased GSK had chosen the UK to apply for the first phase of human testing for the vaccine.
Mailonline
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