Wednesday, April 1, 2015

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

<span id="midArticle_start"/><span id="midArticle_0"/> (Reuters) - Early-stage trials of anexperimental Ebola vaccine, two in the United States and four inAfrica and Europe, have found that it appears to be safe andtriggered robust production of Ebola-fighting antibodies,scientists reported on Wednesday.



<span id="midArticle_1"/>Since trials cannot ethically expose volunteers to Ebola,the production of antibodies is a proxy for whether vaccinescould prevent or even treat the disease.



<span id="midArticle_2"/>There is currently no vaccine or specific treatment forEbola, which has killed over 10,000 people in West Africa sincelast spring, according to the World Health Organization. It isthe worst Ebola epidemic in history, but finally appears to beabating.



<span id="midArticle_3"/>The trials all tested a vaccine called VSV-ZEBOV, which wasdeveloped at the Public Health Agency of Canada and licensed toNewLink Genetics Corp and then to Merck & Co Inc. It consists of a cattle virus called rVSV that has beenengineered to carry Ebola genes, which produce proteins meant totrigger production of anti-Ebola antibodies.



<span id="midArticle_4"/>According to separate teams of scientists, that is whathappened, two papers in the New England Journal of Medicinereported.



<span id="midArticle_5"/>In the U.S. trials, conducted independently butcooperatively at the National Institutes of Health and theWalter Reed Army Institute of Research starting last October, 52healthy adult volunteers received single injections of saline oreither of two doses of vaccine.



<span id="midArticle_6"/>The most common side effects were mild, such as pain at theinjection site and short-lived fever. All 40 participants whoreceived vaccine produced anti-Ebola antibodies within 28 days,with most responding sooner.



<span id="midArticle_7"/>The higher dose triggered triple the antibody response ofthe lower dose. The "robust" response to a single dose "could beparticularly useful in outbreak interventions," said WalterReed's Col. Stephen Thomas, senior author of the U.S. paper.



<span id="midArticle_8"/>The higher dose is being tested in a larger trial inLiberia. Partly through that trial, both VSV-ZEBOV and anexperimental vaccine from GlaxoSmithKline PLC calledcAd3-EBOZ "appear to be safe," NIH announced last week.[IDn:L2N0WS2WN]



<span id="midArticle_9"/>The other studies were similarly encouraging.



<span id="midArticle_10"/>In coordinated trials in Germany, Switzerland, Gabon andKenya, 158 healthy volunteers received a placebo or any of fivedose-levels of VSV-ZEBOV vaccine.



<span id="midArticle_11"/>Although the Geneva study was temporarily halted last yearafter 11 of 51 participants developed arthritis, overall therewere "no serious vaccine-related adverse events," theresearchers reported. All 150 people who received vaccinedeveloped antibodies to Ebola with higher responses to higherdoses. (Reporting by Sharon Begley, editing by G Crosse)



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