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Ebola vaccine 'promising' say scientists after human trial | Ebola vaccine 'promising' say scientists after human trial |
(4 days later) | |
The first human trial of an experimental vaccine against Ebola suggests that it is safe and may help the immune system to combat the virus. | The first human trial of an experimental vaccine against Ebola suggests that it is safe and may help the immune system to combat the virus. |
Twenty volunteers were immunised in the United States. Scientists at the US National Institutes of Health (NIH) described the results as "promising". | Twenty volunteers were immunised in the United States. Scientists at the US National Institutes of Health (NIH) described the results as "promising". |
The research is published in the New England Journal of Medicine (NEJM). | The research is published in the New England Journal of Medicine (NEJM). |
None of those immunised suffered major side-effects and all produced antibodies. | None of those immunised suffered major side-effects and all produced antibodies. |
Dr Anthony Fauci of the NIH told the BBC: "On safety and on the ability to produce an appropriate immune response we can call this trial an unqualified success, even though it was an early Phase One trial." | Dr Anthony Fauci of the NIH told the BBC: "On safety and on the ability to produce an appropriate immune response we can call this trial an unqualified success, even though it was an early Phase One trial." |
The volunteers were divided into two groups, receiving either a low or high dose. The antibody response was stronger among those receiving the higher dose. | The volunteers were divided into two groups, receiving either a low or high dose. The antibody response was stronger among those receiving the higher dose. |
The investigators found that seven of the high dose and two of the low dose volunteers produced T-cell immune responses, which may be important in protection against Ebola viruses. | |
The vaccine uses a chimpanzee cold virus which has been genetically engineered to carry a non-infectious Ebola protein on its surface. | The vaccine uses a chimpanzee cold virus which has been genetically engineered to carry a non-infectious Ebola protein on its surface. |
There are four trials under way of this experimental vaccine. | |
The US vaccine is bivalent - aimed at giving protection against the Sudan and Zaire strains of Ebola. It is the latter which is responsible for the current outbreak. | The US vaccine is bivalent - aimed at giving protection against the Sudan and Zaire strains of Ebola. It is the latter which is responsible for the current outbreak. |
Trials of a monovalent vaccine - against the Zaire strain - are also under way in Oxford, Mali and Switzerland. | |
If these also yield positive results then the monovalent vaccine will be offered to thousands of health workers in West Africa. | |
Dr Fauci said: "It will be this large Phase Two/Three trial in West Africa which will show whether the vaccine works and is really safe." | |
He added: "If the outbreak is still going on six months from now and the vaccine at that point is shown to be effective, it could have a very positive impact on the current epidemic." | |
But he said the long-term aim was to produce a vaccine which would protect against future outbreaks. | But he said the long-term aim was to produce a vaccine which would protect against future outbreaks. |
If the vaccine does work, it is unclear how long the protection would last. | If the vaccine does work, it is unclear how long the protection would last. |
Indemnity agreement | Indemnity agreement |
These kinds of questions are usually settled during the early stages of human trials. | These kinds of questions are usually settled during the early stages of human trials. |
But such is the pressing humanitarian need for something which protects against Ebola, the whole trial process is being accelerated at unprecedented speed. | But such is the pressing humanitarian need for something which protects against Ebola, the whole trial process is being accelerated at unprecedented speed. |
In an editorial in the NEJM Dr Daniel Bausch said that while the trial left many questions unanswered, an Ebola vaccine was "one step closer". | In an editorial in the NEJM Dr Daniel Bausch said that while the trial left many questions unanswered, an Ebola vaccine was "one step closer". |
The experimental vaccine is being manufactured by the British drugs giant GlaxoSmithKline (GSK). | The experimental vaccine is being manufactured by the British drugs giant GlaxoSmithKline (GSK). |
The company says it can produce one million doses a month by the end of 2015. | The company says it can produce one million doses a month by the end of 2015. |
This will require a significant financial outlay. It is asking for an indemnity agreement in case problems such as unforeseen side effects were to emerge in the future. | This will require a significant financial outlay. It is asking for an indemnity agreement in case problems such as unforeseen side effects were to emerge in the future. |
GSK's chief executive Sir Andrew Witty told the BBC: "We are not waiting for that to be settled [but] it is obvious there are some risks that companies should not be expected to carry on their own." | GSK's chief executive Sir Andrew Witty told the BBC: "We are not waiting for that to be settled [but] it is obvious there are some risks that companies should not be expected to carry on their own." |
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