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Evaluating Clinical Trial Designs for Investigational Treatments of Ebola Virus Disease

PLOS MEDICINE   by Ben Cooper and others                                                             April 14, 2015
Experimental treatments for Ebola virus disease might reduce EVD mortality. There is uncertainty about the ability of different clinical trial designs to identify effective treatments, and about the feasibility of implementing individually randomised controlled trials during an Ebola epidemic

A treatment evaluation programme for use in EVD was devised using a multi-stage approach (MSA) with two or three stages, including both non-randomised and randomised elements. The probabilities of rightly or wrongly recommending the experimental treatment, the required sample size, and the consequences for epidemic outcomes over 100 d under two epidemic scenarios were compared for the MSA, a sequential randomised controlled trial (SRCT) with up to 20 interim analyses, and, as a reference case, a conventional randomised controlled trial (RCT) without interim analyses.

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Testing of Ebola vaccine is underway in Sierra Leone

USA TODAY by Liz Szabo                                                                 April 14, 2015
Sierra Leone has begun testing an experimental Ebola vaccine, officials of the Centers for Disease Control and Prevention announced Tuesday.
                                                                                            (Photo: CELLOU BINANI, AFP/Getty Images)

The $25 million study, funded through $5.4 billion in Ebola aid authorized by Congress, will test vaccines on 6,000 "front-line workers," including doctors, nurses, burial workers and others, who are at highest risk of the disease.

But with only a handful of new Ebola cases being reported now in Sierra Leone, it may be difficult to get a clear answer on whether the vaccine actually works, the CDC acknowledges. If there are no new cases of Ebola among vaccinated volunteers, for example, researchers won't know if that's the result of the immunizations or because the outbreak has faded....

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2 new ebola vaccines pass important early test, researchers say

NEW YORK TIMES   by Denis Grady                                                                 April 9. 2015

Two  new Ebola vaccines have passed an important test, protecting monkeys against the strain of the virus responsible for the current deadly outbreak, researchers reported on Wednesday. Only one dose was needed, and there were no apparent side effects..

Thomas W. Geisbert, an Ebola expert at the University of Texas Medical Branch in Galveston, in his office. Credit Michael Stravato for The New York Times

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UN envoy: Expect Ebola vaccine in coming months

INQUIRER.NET  by Kristine Angeli Sabillo                  APRIL 8, 2015

MANILA --As the Ebola outbreak in West Africa winds down, the United Nations is optimistic that a vaccine against the deadly virus will be made available in the next several months.

“Clinical trials have have now been undertaken of candidate vaccines, two of them. They are now at an advanced stage,” Dr. David Nabarro, UN secretary general special envoy on Ebola, told reporters in Manila on Wednesday.

“I believe that we will have a vaccine against Ebola that is available and can be used particularly for doctors and nurses who provide treatment for people with the disease in the coming months,” he added.

According to the World Health Organization, the two vaccine candidates undergoing efficacy trials are ChAd3-ZEBOV, developed by GlaxoSmithKline (GSK), and rVSV-ZEBOV, developed by NewLink Genetics and Merck Vaccines USA. The first is being developed in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID) and the second with the Public Health Agency of Canada.

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Ebola Vaccine 2015: Guinea Seen As Best Hope For Preventative Drug Trials, But Time Is Running Out

INTERNATIONAL BUSINESS TIMES by Philip Roth       April 7, 2015

(Two stories. Scroll down)
Health officials’ best bet for discovering a vaccine for Ebola lies with the West African country of Guinea, where the outbreak that has killed an estimated 10,500 over the past year began, and the place that researchers largely ignored when it came time for drug trials. As researchers race to find a vaccine before the window of opportunity closes – essentially, before the epidemic is brought to an end -- scientists with the World Health Organization are beginning to test a vaccine in Guinea manufactured by researchers in the U.S. and Canada.


The race to find a vaccine for Ebola is in its final lap. Pictured, research assistant Georgina Bowyer works on a vaccine for Ebola at the Jenner Institute in Oxford, southern England, Jan. 16, 2015. Reuters

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Merck, NewLink Ebola vaccine appears safe, effective in new studies

REUTERS by Sharon Bagley                                                                      April 1, 2015

Early-stage trials of an experimental Ebola vaccine, two in the United States and four in Africa and Europe, have found that it appears to be safe and triggered robust production of Ebola-fighting antibodies, scientists reported on Wednesday.

Since trials cannot ethically expose volunteers to Ebola, the production of antibodies is a proxy for whether vaccines could prevent or even treat the disease.

The trials all tested a vaccine called VSV-ZEBOV, which was developed at the Public Health Agency of Canada and licensed to NewLink Genetics Corp and then to Merck & Co Inc. It consists of a cattle virus called rVSV that has been engineered to carry Ebola genes, which produce proteins meant to trigger production of anti-Ebola antibodies.

According to separate teams of scientists, that is what happened, two papers in the New England Journal of Medicine reported.

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BioCryst gets HHS contract for Ebola drug development

CENTER FOR INFECTIOUS DISEASE RESEARCH AND POLICY by Lisa Schnerring               March 31, 2015

The US Department of Health and Human Services (HHS) announced today that it has awarded BioCryst Pharmaceuticals a $12 million grant to continue development of BCX4430, a small-molecule drug designed to treat Ebola and other filovirus infections, and to prepare for large-scale manufacturing of the agent.

Studies in nonhuman primates suggest that the drug is effective against Ebola and Marburg viruses and could be useful as a broad-spectrum antiviral, the HHS said in a statement. BCX4430 is currently in phase 1 human trials, and if results show safety, it could be one of the treatments to be tested for efficacy in clinical trials.

BCX4430 is the first small-molecule Ebola treatment that BARDA has supported. Other Ebola products in development that have received BARDA funding include the monoclonal antibody cocktail ZMapp and three vaccines.
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New Kind of “Tandem” Solar Cell Developed

Tandem solar chips.

Image: Tandem solar chips. - March 25th 2015 - David L. Chandler

Researchers at MIT and Stanford University have developed a new kind of solar cell that combines two different layers of sunlight-absorbing material in order to harvest a broader range of the sun’s energy. The development could lead to photovoltaic cells that are more efficient than those currently used in solar-power installations, the researchers say.

The new cell uses a layer of silicon — which forms the basis for most of today’s solar panels — but adds a semi-transparent layer of a material called perovskite, which can absorb higher-energy particles of light.


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Scientists argue over access to remaining Ebola hotspots

The slowdown in the West African Ebola epidemic is welcome news and reason to be hopeful—but it’s also creating a new problem. With fewer new cases occurring, it is becoming more and more difficult to test vaccines and drugs. As a result, conflicts are looming over who can test Ebola drugs and vaccines in Guinea and Sierra Leone.

An Ebola treatment unit in Guinea.Samuel Hanryon/MSF

In Guinea, a large consortium that includes Doctors Without Borders (MSF) and the World Health Organization (WHO) vaccinated the first volunteers at risk of Ebola on Monday in a big trial of a vaccine produced by Merck and NewLink Genetics. But the team feels threatened because researchers at the U.S. National Institutes of Health (NIH) are looking to move another vaccine study from Liberia, where the epidemic has come to a virtual standstill, to Guinea.

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Ebola whole virus vaccine shown effective, safe in primates

SCIENCE DAILY                                                March 26, 2015

(Scroll down for complete paper.)
An Ebola whole virus vaccine, constructed using a novel experimental platform, has been shown to effectively protect monkeys exposed to the often fatal virus.

The vaccine, described today (March 26, 2015) in the journal Science, was developed by a group led by Yoshihiro Kawaoka, a University of Wisconsin-Madison expert on avian influenza, Ebola and other viruses of medical importance. It differs from other Ebola vaccines because as an inactivated whole virus vaccine, it primes the host immune system with the full complement of Ebola viral proteins and genes, potentially conferring greater protection.

"In terms of efficacy, this affords excellent protection," explains Kawaoka, a professor of pathobiological sciences in the UW-Madison School of Veterinary Medicine and who also holds a faculty appointment at the University of Tokyo. "It is also a very safe vaccine."

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