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The Race for the Ebola Vaccine

THE DAILY BEAST  by Abby Haglage                                                                  Jan. 7, 2015

...Although a few smaller companies have become involved in the race for a vaccine, three major pharmaceutical makers are taking the lead—each pursuing a different vaccine. The trials are unprecedented for a variety of reasons, including the rapid timeline (trials of this nature generally take three to four years).

                                                      Steve Parsons-WPA Pool/Getty Images

Each individual race involves an unusual collaboration between researchers, manufacturers, and public-health entities. Together, the teams are working 24 hours a day for a product that promises much higher risk than it does profit.

Here’s what you need to know about the Ebola vaccine front-runners.

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http://www.thedailybeast.com/articles/2015/01/07/the-race-for-the-ebola-vaccine.html

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J&J, Bavarian Nordic start clinical tests in Ebola vaccine race

REUTERS     by Ben Hirschler                              Jan. 6, 2015
LONDON --Johnson & Johnson has started clinical trials of its experimental Ebola vaccine, which uses a booster from Denmark's Bavarian Nordic, making it the third such shot to enter human testing.

The initiation of the Phase I study in Britain, which had been expected about now, marks further progress in the race to develop a vaccine against a disease that has killed more than 8,000 people in West Africa since last year.

Two other experimental vaccines, one from GlaxoSmithKline and a rival from NewLink and Merck, are already in clinical development. However, the J&J vaccine offers a different approach, since it involves two separate injections.

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http://www.reuters.com/article/2015/01/06/us-health-ebola-vaccine-j-j-idUSKBN0KF0HH20150106

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Ebola: as ZMapp stocks run out doctors turn to alternative treatments

THE GUARDIAN by                                 Jan, 5, 2015
LONDON --Even at the Royal Free hospital in London, the lead UK specialist centre for Ebola, doctors have limited options for treating their patients. In the end, survival may depend more on the strength of an individual’s immune system than anything medical science is currently able to do.

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Merck-NewLink Ebola vaccine trial resumes at lower dose: Geneva hospital

(Two stories. Scroll down.)

REUTERS                                                       Jan. 5, 2015

GENEVA --The clinical trial of an Ebola vaccine developed by Merck and NewLink resumed on Monday at a lower dose after a pause to assess complaints of joint pains in some volunteers, the University of Geneva hospital said.

The Geneva hospital announced on Dec. 11 that its vaccine trial had been suspended as a precautionary measure after four patients complained of joint pains. On Monday, the hospital said 10 of 59 volunteers who received the vaccine had felt pains in their joints "similar to rheumatism" after some two weeks, but these symptoms had disappeared rapidly without any treatment.

Swissmedic, the Swiss regulatory agency, and ethics and safety committees have approved the resumption of the trial at a lower dose, the hospital said in a statement.

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http://www.reuters.com/article/2015/01/05/us-health-ebola-vaccine-idUSKBN0KE0XP20150105
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FDA approves new Roche Ebola test for emergency use

WASHINGTON POST by  Rachel Feltman                      Dec. 29, 2014

Pharmaceutical company Roche announced Monday that the U.S. Food and Drug Administration had provided an Emergency Use Authorization -- a sort of pre-approval for use in particularly bad outbreaks -- for a new kind of Ebola test.

This isn't the first test to get this kind of approval during the 2014 outbreak of the Zaire strain of Ebola, which has killed more than 7,500 people to date and is still an ongoing crisis in parts of West Africa.... 

So it's no surprise that Swiss company Roche has put its version of a rapid test forward. The LightMix Ebola Zaire rRT-PCR Test works in about three hours, and is designed for Roche's testing consoles.

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Next in Ebola Plan: UN Teams to Study Lines of Transmission

REUTERS                                                              Dec. 24, 2014

ACCRA—Medical detective work will be the next big phase in the fight against Ebola when the United Nations deploys hundreds of health workers to identify chains of infection as the virus passes from person to person, top U.N. health workers said.
Health workers bury the body of a suspected Ebola victim at a cemetery in Freetown, Dec. 21, 2014.

The health teams will travel to each district and region of Guinea, Sierra Leone and Liberia, the three countries at the center of the epidemic, to trace who each infected person has potentially contacted.

The effort will run in parallel with measures to minimize the spread of infection, such as treating all Ebola patients in specialized centers and burying all victims safely.

But Phase Two of the plan is to contain the virus by understanding its lines of transmission, said World Health Organization Director-General Margaret Chan.

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Ebola raises profile of blood-based therapy

NATURE     by  Delcan Butler                                                                                        Dec. 23, 2014

With no drugs available to treat Ebola, eyes are turning to a therapy that had largely been relegated to the history books: transfusing patients with blood plasma donated by survivors, which contains antibodies against the virus.

Survivors of Ebola carry antibodies that might be used to save the lives of those infected with the virus. Michel du Cille/The Washington Post via Getty Images

Clinical trials of convalescent plasma therapy (CPT) have started in the past few weeks in Liberia, and are due to begin soon in Guinea and Sierra Leone. If the therapy saves lives, the approach could quickly be scaled up.

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Ebola vaccine 'promising in African populations'

BBC     By Smitha Mundasad                                Dec. 22, 2014
The first-ever trial of an Ebola vaccine in Africa shows promising initial results, according to a report in the Lancet medical journal.

Scientists say it is a crucial step as other vaccines have shown lower levels of protection in African populations.

Tests involving Ugandan and American volunteers reveal the vaccine is so far safe and generates an immune response in both populations.

It provides reassurance for other trials currently underway, they say.

No proven vaccine exists to prevent people from getting the disease, though several trials are underway.

Researchers from the National Institutes of Health tested this experimental vaccine on healthy adults in Uganda, having first trialled it in the United States.

Dr Julie Ledgerwood, the lead researcher, said: "This is the first study to show comparable safety and immune response of an experimental Ebola vaccine in an African population.

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http://www.bbc.com/news/health-30577776

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GSK Ebola vaccine trial seen moving to wider phase in February

REUTERS                                                                                              Dec. 19, 2014

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.

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The Ebola Treatment You Haven't Heard Of

FORBES       by David Kroll                                                                                              Dec. 19, 2014

Pharmaceuticals and biotechnology-derived products have attracted the greatest public and professional interest in treating victims of Ebola virus disease. But a privately-held, small company with a treatment for shock and multi-organ failure may be the dark horse victor in the race to stop the West African outbreak. LB1148 from San Diego-based Leading BioSciences is starting Phase 2 clinical trials that build on 12 years of NIH-funded research to address an underappreciated, common denominator in shock and organ failure, including shock caused by Ebola infection.

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http://www.forbes.com/sites/davidkroll/2014/12/19/the-ebola-treatment-you-havent-heard-of/

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