EbolaEbola vaccine to be tested on humans

Efforts to test an Ebola vaccine on humans have reached a milestone when BioProtection Systems, through its parent company, NewLink Genetics Corporation, confirmed that it is prepared to launch the first human safety trial of a vaccine, which the company licensed after it was developed by scientists at the Public Health Agency of Canada. The company has also arranged to manufacture tens of thousands of vaccine doses within “the next month or two,” Dr. Charles Link, NewLink’s chief executive, said.

msn News reports that last week, BioProtection Systems received $1 million from the U.S. Defense Threat Reduction Agency (DTRA) for more preclinical toxicology studies, and to step up manufacturing to allow human trials to begin quickly. “DTRA said, ‘we want this to move quickly,’” Link said. “Before that, I’d have said it would take eight to 10 months before we could launch human studies, but now it’s a matter of weeks.”

The NewLink vaccine replaces the genes from vesicular stomatitis virus (VSV), a pathogen found in livestock, with a gene from the Ebola virus. The Ebola gene then develops a harmless protein that sits on the virus’s outer coat. Scientists believe that after VSV is injected, the body’s immune system will recognize the Ebola protein as foreign, and will begin making antibodies that destroy Ebola viruses, all of which have the protein.

The current Ebola outbreak has killed roughly 1,000 people in West Africa, and health officials fear that the virus could spread. As a result, pharmaceuticals and health agencies have stepped up efforts to develop vaccines and treatments, which for years had been moving at a slow pace.

Public health agencies, including the World Health Organization, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have shown strong support for an Ebola vaccine and treatment.

NewLink is now awaiting confirmation from the CDC, the National Institutes of Health, and Walter Reed Army Medical Center about where to conduct human trials. The company reserved doses from ongoing studies in lab animals, so there would be no need to wait for manufacturing to take place before testing its vaccine on humans. The human trials would require between twenty to 100 healthy volunteers to get sufficient data. Members of the military and medical workers working in West Africa are the likely participants of the trial, but NewLink awaits FDA approval before the trial can proceed in the United States. “I have never seen the FDA so supportive,” Link said, adding that he expects to receive FDA approval soon. The FDA could not confirm discussions about medical products under development, its spokeswoman Erica Jefferson said.

NewLink, the CDC, and WHO are also considering hosting human safety trials on medical workers in West Africa, Link said. “We’re here to help and do whatever we can” in the disastrous Ebola outbreak, Link added. “My team has been told to get it done tomorrow.”