New Ebola vaccine may reshape regulation of clinical drug trials

When Ebola broke out in West Africa in December 2013, triggering the largest-ever epidemic of the disease, there was no vaccine or drug that had been shown to be safe and effective in people. Just 20 months later, a vaccine seems to confer total protection against infection, according to the preliminary results of a trial in Guinea that were published on July 31.

Called rVSV-ZEBOV, it consists of a livestock virus that has been genetically engineered to masquerade as the Ebola virus. It was developed by the Public Health Agency of Canada, licensed to the pharmaceutical company Merck and tested by an international collaboration of funders, scientists, companies, organizations and govern­ments, including the World Health Organization (WHO).

Getting clinical trials approved by regulators usually takes years, as does conducting the gold standard of randomized controlled trials. That means that outbreaks tend to be over before trials can even begin. Clinical trials are also usually done in well-equipped research hospitals, and quality trials have generally been considered impossible to carry out in the often-atrocious field conditions of deadly outbreaks. The urgency of tackling Ebola changed all that. Last September, the WHO-supported collaboration pulled out all the stops to accelerate testing of treatments and vaccines that had shown promise in animals. It cut through the red tape and came up with trial designs that could quickly provide data at least good enough to inform efforts to control the outbreak. The rVSV-ZEBOV trial is one of several that came about as a result.

xThe GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis. Read full, original post: How Ebola-vaccine success could reshape clinical-trial policy

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