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WHO experts chart next steps for Ebola vaccine trials

CENTER FOR INFECTIOUS DISEASE AND POLICY RESEARCH     by Lisa Schnirring                                 Jan. 9, 2015

The next steps in testing Ebola vaccines as well as a picture of how they might be used in West Africa's outbreak region became clearer today as officials from the World Health Organization (WHO) shared the outcome of yesterday's (Thursday's) high-level meeting in Geneva.

Large phase 3 trials in West Africa's outbreak setting will be next up to see if the vaccines work, with the studies designed to collect more safety data, a task usually covered in phase 2 trials, experts involved in the meeting said today at a WHO media telebriefing. However, as Ebola infections drop off in the outbreak region, scientists face a closing window of opportunity to see how the vaccines perform in a real-life setting.

Experts also signaled a possible role for two Ebola vaccine formulations: a single-dose vaccine providing shorter-term immunity that could be used to tamp down Ebola flare-ups and a prime-boost vaccine that may provide more durable immunity and could be used for other immunization strategies.

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In Africa, a Decline in New Ebola Cases Complicates Vaccine Development

NEW YORK TIMES      by Andrew Pollack                                                           Jan. 9, 2015

As authorities and drug companies hurriedly prepare to begin testing Ebola vaccines in West Africa, they are starting to contemplate a new challenge: whether an ebbing of the outbreak could make it more difficult to determine if the experimental vaccines are effective.

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Health 2 Leading Ebola Vaccines Appear Safe, Further Tests Starting

ASSOCIATED PRESS  by Maria Cheng                                                                          Jan. 9, 2015
LONDON --The World Health Organizationsays the two leading Ebola vaccines appear safe and will soon be tested in healthy volunteers in West Africa.

After an expert meeting this week, WHO said there is now enough information to conclude that the two most advanced Ebola vaccines ? one made by GlaxoSmithKline and the other licensed by Merck and NewLink ? have "an acceptable safety profile."

In a press briefing on Friday, Dr. Marie-Paule Kieny, who heads WHO's Ebola vaccine efforts, said "the cupboard (for Ebola vaccines) is filling up rapidly."

She said further trials in healthy people in West Africa, including health workers, are scheduled to start soon. Kieny added several other vaccines were being developed in the U.S., Russia and elsewhere.

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http://abcnews.go.com/Health/wireStory/leading-ebola-vaccines-safe-tests-starting-28107527

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Ebola: vaccine trials can offer ‘signs of hope’ says UN health chief

UNITED NATIONS NEWS CENTRE                                Jan. 8, 2015

GENEVA--The United Nations World Health Organization (WHO) today convened in Geneva its second ever high-level meeting on Ebola vaccines access and financing, to review the current status of clinical trials and plans for Phase II and Phase III efficacy trials.

WHO mobile lab scientists at the crossing point between Guinea and Sierra Leone, two of the countries affected by the Ebola outbreak in West Africa. Photo: WHO/Saffea Gborie

“We are here to take stock, plan the next steps, and make sure that all partners are working in tandem. We all want the momentum and sense of urgency to continue,” Dr. Margaret Chan, Director-General of WHO said as she kicked off the meeting.

The most advanced candidate Ebola vaccine is scheduled to enter Phase III efficacy clinical trials in West Africa in January/February 2015, and if shown effective – will be available for deployment a few months later.

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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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Where Could Ebola Strike Next? Scientists Hunt Virus In Asia January 02, 2015

NATIONAL PUBLIC RADIO  by Michaeleen Doucleff              Jan. 2, 2015

...Scientists think bats likely triggered the entire Ebola epidemic in West Africa....

So now the big question is: Where else in the world is Ebola hiding out in bats? Where could the next big outbreak occur?

Ecologists found signs of Ebola in a Rousettus leschenaultii fruit bat. These bats are widespread across south Asia, from India to China. Kevin Olival/EcoHealth Alliance

.. ecologist Kevin Olival at EcoHealth Alliance in New York City... hunts down another virus in bats, called Nipah. In humans, it causes inflammation in the brain and comas....

Nipah has outbreaks every few years in Bangladesh. So Olival went there back in 2010 and captured a bunch of bats. Many had signs of Nipah in their blood. Others had something surprising: "There's antibodies to something related to Ebola Zaire."

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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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