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Promising Ebola Vaccine Likely To Move On To Second Phase Trial

Promising Ebola Vaccine Likely To Move On To Second Phase Trial
Reuters
Dr Felicity Hartnell, who is a clinical research fellow at Oxford University, injects former nurse Ruth Atkins the first of 60 healthy volunteers in the U.K. who will receive an experimental vaccine against Ebola in Oxford, England Wednesday Sept. 17, 2014. The vaccine was developed by the U.S. National Institutes of Health and GlaxoSmithKline and targets the Zaire strain of Ebola, the cause of the ongoing outbreak in West Africa. A trial of the same vaccine has already begun in the U.S. (AP Photo/Steve Parsons/Pool)
Dr Felicity Hartnell, who is a clinical research fellow at Oxford University, injects former nurse Ruth Atkins the first of 60 healthy volunteers in the U.K. who will receive an experimental vaccine against Ebola in Oxford, England Wednesday Sept. 17, 2014. The vaccine was developed by the U.S. National Institutes of Health and GlaxoSmithKline and targets the Zaire strain of Ebola, the cause of the ongoing outbreak in West Africa. A trial of the same vaccine has already begun in the U.S. (AP Photo/Steve Parsons/Pool)

GENEVA, Dec 19 (Reuters) - Trials of GlaxoSmithKline's experimental Ebola vaccine are likely to move to a second phase in February, later than previously suggested, after a meeting of national regulators said they needed more information.

The World Health Organization, which hosted a meeting of national regulatory authorities and ethics committees earlier this week, said they had thoroughly discussed all aspects of the proposed trials at the two-day meeting.

"Reviewing countries requested additional documentation from the manufacturer of the vaccine, GlaxoSmithKline, before authorization of the trials," the WHO said in a statement.

Countries where the trials are planned -- Cameroon, Ghana, Mali, Nigeria and Senegal -- should receive and review the additional information by the end of January.

"If these steps are completed to the satisfaction of the national authorities, Phase II trials are likely to begin in February," the statement said.

The GSK vaccine is already undergoing Phase I trials, to check its safety in humans, in Switzerland, Britain, Mali and the United States, and is one of the two leading candidate vaccines for Ebola already undergoing tests.

The other vaccine, from NewLink Genetics is also still in Phase I trials. One of its trials, in Geneva, was suspended earlier this month after some patients complained of joint pains.

Johnson & Johnson plans to start clinical trials with a third vaccine shortly.

WHO officials have said they hope the unprecedented fast-track trials mean vaccines may be widely available around the middle of 2015, although they also hope the outbreak will be over by then. So far it has killed almost 7,000 people.

There are still many unresolved questions about the use of experimental vaccines, including whether subjects will need one or two injections. (Reporting by Tom Miles; editing by Ben Hirschler and Mark Trevelyan)

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Before You Go

1
Ebola is highly infectious and even being in the same room as someone with the disease can put you at risk
ASSOCIATED PRESS
Not as far as we know. Ebola isn't contagious until symptoms begin, and it spreads through direct contact with the bodily fluids of patients. It is not, from what we know of the science so far, an airborne virus. So contact with the patient's sweat, blood, vomit, feces or semen could cause infection, and the body remains infectious after death. Much of the spread in west Africa has been attributed to the initial distrust of medical staff, leaving many to be treated at home by loved ones, poorly equipped medics catching the disease from patients, and the traditional burial rites involving manually washing of the dead body. From what we know already, you can't catch it from the air, you can't catch it from food, you can't catch it from water.
2
Cancelling all flights from west Africa would stop the spread of Ebola
ASSOCIATED PRESS
This actually has pretty serious implications. British Airways suspended its four-times-weekly flights to Liberia and Sierra Leone until the end of March, the only direct flight to the region from the UK. In practice, anyone can just change planes somewhere else and get to Britain from Europe, north Africa, or the Middle East. And aid agencies say that flight cancellations are hampering efforts to get the disease under control, they rely on commercial flights to get to the infected regions. Liberia's information minister, Lewis Brown, told the Telegraph this week that BA was putting more people in danger. "We need as many airlines coming in to this region as possible, because the cost of bringing in supplies and aid workers is becoming prohibitive," he told the Telegraph. "There just aren't enough seats on the planes. I can understand BA's initial reaction back in August, but they must remember this is a global fight now, not just a west African one, and we can't just be shut out." Christopher Stokes, director of MSF in Brussels, agreed: “Airlines have shut down many flights and the unintended consequence has been to slow and hamper the relief effort, paradoxically increasing the risk of this epidemic spreading across countries in west Africa first, then potentially elsewhere. We have to stop Ebola at source and this means we have to be able to go there.”
3
Temperature screening at airports is an effective way to stop those who have the disease from travelling
ASSOCIATED PRESS
The screening process is pretty porous, especially when individuals want to subvert it. Wake up on the morning of your flight, feel a bit hot, and you definitely don't want to be sent to an isolation booth for days and have to miss your flight. Take an ibuprofen and you can lower your temperature enough to get past the scanners. And if you suspect you have Ebola, you might be desperate to leave, seeing how much better the treatment success has been in western nations. And experts have warned that you cannot expect people to be honest about who they have had contact with. Thomas Eric Duncan, the Ebola victim who died in Texas, told officials he had not been in contact with anyone with the disease, but had in fact visited someone in the late stages of the virus, though he said he believed it was malaria. The extra screening that the US implemented since his death probably wouldn't have singled out Duncan when he arrived from hard-hit Liberia last month, because he had no symptoms while travelling.
4
Border staff should stop people coming in to the country who are at risk
LEON NEAL via Getty Images
They're not doctors, and it's a monumental task to train 23,500 people who work for the UK Border Agency how to correctly diagnose a complex disease, and spot it in the millions of people who come through British transport hubs. Public Health England has provided UK Border Force with advice on the assessment of an unwell patient on entry to UK, but they can't be expected to check everyone.
5
Screening at British airports should be implemented to stop unwell people coming in from affected areas
ASSOCIATED PRESS
As mentioned before, the UK, especially London, is a major transport hub. Unlike the US, most of those coming from west Africa will have crossed through Europe, so infected people could be coming from practically anywhere, not just flights directly from those countries. This would require the UK to screen every returning traveller, as people could return to the UK from an affected country through any port of entry. This would be huge numbers of low risk people, at vast, vast expense.
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