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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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http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001815

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Ebola virus not mutating as quickly as thought

SCIENCE NEWS  by Ashley Yaeger                                                      March 26, 2015

(Scroll down for full study.)

The virus causing the current Ebola epidemic in West Africa is not evolving as quickly as some scientists had suggested.

REGULAR RATE  A genetic analysis suggests that the Ebola virus, shown here in orange, is not evolving as fast as expected.

In a paper last August, researchers reported that the virus (Zaire ebolavirus) was altering its genes almost twice as fast as it had during previous Ebola outbreaks in Central Africa (SN: 9/20/14, p. 7). However, a new genetic analysis shows that the virus is mutating at roughly the same rate as in past outbreaks, researchers report online March 26 in Science. The finding suggests the virus has not become more virulent or transmissible during the West Africa outbreak.

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Liberians overcome fear to volunteer for Ebola vaccine trial

ASSOCIATED PRESS  by Jpnathan Paye-Layleh             March 22, 2015

MONROVIA, Liberia — Liberians are overcoming their fears of Ebola to volunteer for a vaccine trial...

One year after the World Health Organization declared the Ebola outbreak, vaccine trials are under way in Liberia and Guinea. Sierra Leone will start a trial later this month.

In Liberia, scientists have fanned out across the country to explain the studies and reduce the fear and confusion that have stymied efforts to contain Ebola.

Dr. Stephen Kennedy, the Liberian lead investigator for the study, was among the first people to volunteer for the vaccine trial, getting his injection in front of the media. Similarly, in Guinea, authorities started the study by injecting a series of prominent officials, including the head of the country's Ebola response.

The outreach worked in Liberia, where more than 700 people have volunteered, well beyond the 600 required, according to Kennedy.

Read complete story.
http://news.yahoo.com/liberians-overcome-fear-volunteer-ebola-vaccine-trial-120848405.html

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Deep in the jungle, hunting for the next Ebola outbreak

THE WASHINGTON POST by Kevin Sieff                   March 20, 2015

NOUABALE-NDOKI NATIONAL PARK, Congo Republic — More than 3,000 miles from the fading Ebola crisis in West Africa, a team of U.S.-funded researchers is hunting deep in a remote rain forest for the next outbreak.

Kinshasa, capital of the Democratic Republic of the Congo, is seen just across the Congo River from Brazzaville, capital of Congo Republic. Researchers have come to Congo Republic to explore the role wild pigs may play in the transmission of Ebola from wildlife to humans. Nichole Sobecki/For The Washington Post

 They aren’t looking for infected people. They’re trying to solve one of science’s great mysteries: Where does Ebola hide between human epidemics?

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Decision on Ebola mass vaccination in August at earliest: WHO

REUTERS by Stephanie Nebehay                                                             Feb. 27, 2015

GENEVA -- An independent advisory body will decide in August at the earliest on whether to recommend widespread introduction of an Ebola vaccine, depending on results of clinical trials and the epidemic's course, the World Health Organization said on Friday.

All three worst-hit countries in West Africa - Guinea, Liberia and Sierra Leone - aim to conduct phase III final-stage clinical trials of experimental vaccines.

Liberia is already testing both the GlaxoSmithKline and Merck-NewLink vaccines, while Sierra Leone and Guinea are due to announce plans soon....

WHO spokesman Christian Lindmeier, reporting on a three-day meeting of experts, told a news briefing: "Vaccine introduction is by no means a given and will depend on the results of clinical trials and recommendations from WHO's Strategy Advisory Group of Experts (SAGE) on vaccines and immunization....

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Use of Group Quarantine in Ebola Control — Nigeria, 2014

Morbidity and Mortality Weekly Report (MMWR)

CDC                                                                                                                            Feb. 13, 2015

by Cheri Grigg, DVM1,2, Ndadilnasiya E. Waziri, DVM3, Adebola T. Olayinka, MD3, John F. Vertefeuille, PhD4

On July 20, 2014, the first known case of Ebola virus disease (Ebola) in Nigeria, in a traveler from Liberia  led to an outbreak that was successfully curtailed with infection control, contact tracing, isolation, and quarantine measures coordinated through an incident management system.

During this outbreak, most contacts underwent home monitoring, which included instructions to stay home or to avoid crowded areas if staying home was not possible. However, for five contacts with high-risk exposures, group quarantine in an observation unit was preferred because the five had crowded home environments or occupations that could have resulted in a large number of community exposures if they developed Ebola.

Read complete report.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6405a3.htm?s_cid=mm6405a3_x

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Lack of Effect of Lamivudine on Ebola Virus Replication

CDC EID JOURNAL by  Lisa E. Hensley, Julie Dyall, Gene G. Olinger, and Peter B. Jahrlin (NIH)                     Feb. 12, 2015

The unprecedented number of Ebola virus disease (EVD) cases in western Africa has compelled the world to consider experimental and off-label therapeutics to mitigate the current outbreak. For clinicians, approved drugs are an attractive solution because of known safety profiles and availability.

Oral lamivudine (GlaxoSmithKline, Brentford, UK), a US Food and Drug Administration–approved anti-HIV drug, has been suggested as a possible antiviral agent against Ebola virus (EBOV). In September 2014, a Liberian physician, Dr. Gorbee Logan, reported positive results while treating EVD with lamivudine (1). Thirteen of 15 patients treated with lamivudine survived presumed EVD and were declared virus free. Clinical confirmation of EVD in these cases remains to be verified....

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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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Experts call for faster mobilisation of “overlooked” survivors to contain Ebola epidemic

OXFORD UNIVERSITY PRESS                                                                                  Dec, 10, 2014

In an editorial published online today in the International Journal of Epidemiology, experts from the Departments of Psychiatry and Epidemiology at Columbia University, New York, are calling for survivors of the Ebola epidemic to be mobilised in a bid to hasten containment of the disease.

We already know that the current Ebola outbreak is unique in its magnitude and for its dispersion in dense, mobile populations. Physicians and nurses face high mortality, and foreign aid in the form of medical supplies and staff continues to be unequal to the scope of the problem. With a case recovery rate of around 30% at the present time in West Africa, survivors already number in the thousands.

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Rapid Ebola test is focus of NIH grant to Rutgers scientist

REPORTS Of RESEARCH ON TWO METHODS OF RAPID TESTING FOR EBOLA

(Two items, scroll down)

MEDICAL PRESS                                                                                     Dec. 8, 2014

Rutgers researcher David Alland, working with the California biotechnology company Cepheid, has received a grant of nearly $640,000 from the National Institutes of Health to develop a rapid test to diagnose Ebola as well as other viruses that can cause symptoms similar to Ebola.

Researchers will adapt this cartridge, now used worldwide for tuberculosis screenings, to collect and test samples from potential Ebola patients. Credit: John Emerson

Alland, a professor of medicine and associate dean for clinical research at Rutgers New Jersey Medical School and the principal investigator of the project, says would be able to take the test to small villages and other remote locations where the spread of Ebola has been especially rampant and diagnose patients where they live...

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