Research

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....

BLOOMBERG  Commentary      by Charles Kenney                                              Feb. 3, 2015
...Without good surveillance, disease threats can fester undetected until they are considerably harder to contain. At the moment, countries simply declare they have the capacity to meet global standards and the WHO takes their word for it. There should be a system of independent review, backed up with international assistance and support to ensure that all countries really do have the capacity to track infectious disease outbreaks and control their spread across borders.

....the global health research system is primarily driven by market pressures. The cost of bringing a drug through the regulatory processes to market averages around $1 billion. That's a big reason why pharmaceutical companies would rather spend money on treatments for the diseases of the rich than for conditions that largely affect people in countries like Liberia...

There are two approaches to deal with that problem: lower the cost of drug development and increase the market for the products that emerge. ...

To increase demand, governments can club together to create an "advanced market commitment": If a drug developer produces a vaccine or therapy that meets certain standards, donors precommit to buy it in bulk....