Research

ASSOCIATED PRESS by Maria Cheng                                                                                 Feb. 23, 2015

LONDON – The World Health Organization says 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 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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CENTER FOR INFECTIOUS DISEASE AND POLICY by  Lisa Schnirring                                                      Feb. 13, 2015

Novavax yesterday announced the launch of the first human trial of its recombinant Ebola vaccine, which will make it the fourth candidate vaccine to be tested in phase 1 trials.

Novavax's product is a glycoprotein recombinant nanoparticle vaccine adjuvanted with Matrix M (Ebola GP) to boost immune response. Conducted in Australia, the study will test the safety and immunogenicity of the vaccine, with and without the adjuvant, in 230 healthy adults ages 18 to 50. Subjects will be given two intramuscular injections 3 weeks apart....

Three other Ebola vaccines are in clinical trials. Phase 2 and 3 studies of the two vaccines that are furthest along in trials got under way in Liberia at the end of January. They include two vector virus vaccines, ChAd3, developed by the National Institutes of Health (NIH) and GlaxoSmithKline (GSK), and VSV-EBOV, developed by the Canadian government and licensed by NewLink Genetics and Merck.

A phase 1 trial of a prime-boost Ebola vaccine regimen from Johnson & Johnson launched in early January in the United Kingdom.

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....

REUTERS   by Sharon Begley                                                                                      Feb. 10, 2015

NEW YORK --An experimental Ebola drug from Sarepta Therapeutics Inc protected six of eight lab monkeys injected with the virus, scientists from the company and the U.S. Army reported on Tuesday.

The drug, called AVI-7537, joins ZMapp from Mapp Biopharmaceutical and a compound from Tekmira Pharmaceuticals Corp as the agents shown to cure non-human primates given otherwise-lethal injections of Ebola virus.

The ZMapp and Tekmira drugs protected 100 percent of lab monkeys in studies, giving them a possible edge. But, unlike those, Sarepta's drug has been formally tested in healthy human volunteers at high doses and caused no serious side effects.

Sarepta's $300 million contract with the U.S. Department of Defense to develop drugs against Ebola and the related Marburg virus ended in 2012 due to government funding cuts. The study was completed just before then but not published until the current Ebola outbreak increased interest in the drug....