Stephan Becker is tired of waiting. Virologist at the University of Marburg in Germany is part of a consortium of scientists that is willing to do a trial of a vaccine candidates for Ebola security. But the doses, it is supposed to test on 20 German volunteers are still in Canada. Negotiations with the US company that owns the license for marketing the vaccine that contains a gene for sewn Ebola surface protein in a pathogen known animal viruses such as vesicular stomatitis virus (VSV) have unnecessarily delayed the start of the trial, Becker and several other scientists say science . "It drives me crazy that we're sitting here and could do something, but things do move forward," said Becker.
Today and tomorrow, Ebola scientists and business representatives and regulators are meeting in its headquarters in Geneva, Switzerland, World health Organization (wHO) to discuss how to accelerate the clinical development of vaccines, a process that normally takes years. more specialists and more public health believe that vaccines will have an important role to play in stopping the catastrophic epidemic in West Africa, which has so far caused at least 6553 cases and over 3,000 deaths in Guinea, Sierra Leone and Liberia (These are the reported figures, the real toll is known to be much higher.).
given the emergency, it is inexplicable that one vaccine candidates developed at the public health Agency of Canada (PHAC) Winnipeg, has yet to go into the arms of the first volunteer, said virologist Heinz Feldmann, who helped develop the any vaccine to PHAC. "It's a farce, these doses are lying around there while people are dying in Africa," said Feldmann, who now works in the laboratories of the Rocky Mountains of the US National Institute of Allergy and Infectious Diseases (NIAID) in Hamilton Montana
in the center of the controversy is NewLink Genetics, a small business in Ames, Iowa, who purchased a license to market the Government of Canada's vaccine in 2010 and is suddenly caught in what WHO calls "the most acute severe public health emergency seen in modern times." Becker and others say that the company is dragging its feet the last 2 months because it is worried about losing control of vaccine development . But Brian Wiley, vice president of business development at NewLink Genetics, says the company is doing all it can. "Our program has grown at an unprecedented rate," he said. Although it took another few months, "we would still break a record in terms of getting this into patients." Wiley explains the holdup is the "administrative process": agreement on a protocol, get employees to sign good contracts, provide insurance in case something goes wrong
Marie-Paule Kieny, specialist vaccines and wHO Director-General, disputes NewLink is dragging its feet. . "So far, we have been able to solve problems along the way, to move as quickly as possible," she said.
Phase I trials for another vaccine candidate, which has pitted Ebola genes into a chimpanzee adenovirus, began in early September in the US and UK. "We have human safety data in approximately 20 people and everything looks good so far," said Ripley Ballou, who is in charge of the Ebola vaccine program (GSK) GlaxoSmithKline in Rixensart, Belgium. Further tests are planned for Switzerland, Mali and Uganda; Ballou said altogether 150 volunteers will receive single-dose vaccine.
A Canadian vaccine developed stock VSV is stored to PHAC in Winnipeg. The Canadian government had 1500 doses 8-1000 which he donated to WHO; the rest is held by NewLink Genetics.
Scientists say WHO bottles have already been sent to research centers who plan to phase trials. Such a trial is scheduled to Walter Reed Army Institute of Research in Silver Spring, Maryland; Other studies by a consortium that includes WHO and Becker are on the drawing boards in Hamburg, Germany, in Geneva, and at sites in Kenya and Gabon. PHAC is ready to ship doses "on a moment's notice," said a representative.
But for a clinical trial to begin, regulators need information on how the vaccine was made, and who resides with NewLink Genetics, which has been slow to release, people familiar with the negotiations say. Wiley said he "knows that the logistics are" not on the manufacturing information. he adds that NewLink wants to be in charge of all security tests. "I do not know think it's unreasonable that we want to be in control of the test and get things done," says Wiley.
Kieny acknowledged that VSV vaccine is behind the candidate GSK, which she says possibly "due to the fact that the partnership behind [the GSK vaccine] is more experienced," she hopes that the tests provided at Walter Reed will soon begin; .. those of Europe and Africa can expect to start in late October or early November, she said Wiley said contracts can be signed at the meeting that is taking place in Geneva.
part of the problem may be that NewLink is a small company with about 100 employees, which focused on immunotherapy to fight cancer in recent years. Research and development by the Authority of a Biomedical Advanced US government agency responsible for accelerating the development of emergency medicines and vaccines recently sent two employees to Ames to help Newlink file documents to the States US Food and Drug Administration, a representative of the US government says. "Our foreign aid commitment has nothing to do with our skill, but with urgency around this issue," said Wiley.
The number of Ebola cases is now almost double every 3 weeks. From the start, the experts of Public Health emphasized that the world knows how to contain the Ebola outbreak: find patients early and treat them using very strict hygiene, track and monitor their contacts, and bury dead quickly and safely. But given the magnitude of this epidemic, which has become almost impossible, said Gary Kobinger PHAC. "You would need an army of epidemiologists for it." This has made rapid development of essential vaccines.
"At first we thought that the epidemic would be by the time we prepared a vaccine," said Anthony Fauci, director of NIAID in Bethesda, Maryland. "But the epidemic continued and got dramatically out of control, it has become clear that we need this vaccine to actually contain the epidemic." This does not mean conventional containment strategies should not be used aggressively, and they need larger scale drastically, said Michael Osterholm, director of the Center for Research and Policy at the University Minnesota, Twin Cities infectious diseases.
at the WHO meeting today and tomorrow, experts discuss the many thorny issues that will occur if one or both vaccines successfully pass their Phase I trials. From there, they should be widely available in the affected countries, said Jeremy Farrar, an epidemiologist and head of the Wellcome Trust research charity in London. "I think the big question now is how do we do it while gathering data on safety and efficacy sufficient to be sure that we are doing well," says Farrar.
Fauci believes that, a randomized controlled trial, in which people receive either the vaccine or a real Ebola unrelated shooting such that the vaccine against hepatitis B, will be needed. "If you deploy a vaccine widely in a country, you better be sure it is effective, "he said. But others do not see the use of placebos as an option. "You create a group of people who are not vaccinated and they do not know it," said Kobinger. "If I was a volunteer, I would not be comfortable with this person."
Farrar accepts, moreover, a placebo-controlled study is simply impossible, he said "We are talking about a system totally destroyed healthcare across Liberia and, to some extent, Sierra Leone," said. Farrar. "We just have to be practical." This does not mean scientists will be unable to tell if the vaccine works, he said. Urban areas like Monrovia will inevitably receive the vaccine before reaching other parts, most rural of the country; scientists can compare the impact of the Ebola virus in both areas, in a so-called wedge step study plan. "If you have an effective vaccine to 0%, you immediately."
The offer is likely to be a problem. GSK has promised to produce about 10,000 doses by the end of the year, paid by the Wellcome Trust and others. the company is already working on how to increase production, however, if the first volunteers of the data show that the vaccine has no adverse effects and their immune systems have similar responses that protect monkeys in experiments that attempted to infect them with Ebola. the first signs of what could be available in less than a month, said Ballou. "We would not begin to produce large numbers unless we had evidence that the vaccine has the potential to work," he said.
vaccine production against VSV is already ramping up. The more than 800 bottles now stored in Winnipeg could give a few thousand doses Kobinger said, according to the exact amount needed per dose. "We are making additional power as we speak," Wiley said. "And we expect to have the ability to manufacture tens of thousands of doses by the end of the year." Two other vaccines, another on the basis of VSV and using a modified poxvirus are a few months behind in development.
at the meeting this week, experts will again discuss who gets the vaccine first. most participants in an ethical meeting earlier agents health should be given priority, as they are essential in the fight against Ebola, while presenting a high risk of contracting. in addition, the protection of a vaccine could help convince doctors and nurses to work in affected countries. the vaccine will also be given to other people involved in the outbreak, such as cleaners, ambulance drivers, teams or funeral, Farrar said. But offer the vaccine to patients' families could increase the likelihood they come forward, which would contribute to the detection and control.
The panel participants earlier agreed that children and pregnant women are especially vulnerable and should also be a priority.
Another question is which country to focus on. If early doses will be sent to Liberia, where the epidemic appears to be growing the fastest, or Guinea, who was about to contain the Ebola virus at least twice? "You could make a good case for either," said Brian Greenwood, an epidemiologist specializing in vaccines at the London School of Hygiene & Tropical Medicine, who chairs a session at the meeting. "These are all very difficult issues, and this is why you need to get a lot of brains all the people who really know it from different aspects and try to come to some sort of consensus."
* Ebola files: given the current Ebola epidemic, unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research and articles on viral disease available for researchers and the general public.
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