Friday, July 31, 2015

First human study of Canadian-made Ebola vaccine to start within a few weeks.

TORONTO — The company that has licensed a Canadian-made Ebola vaccine says it hopes to start a Phase 1 trial on the serum within the next few weeks.
The safety data the trial produces could allow the World Health Organization to start using between 800 and 1,000 doses of the vaccine which Canada has donated for the Ebola outbreak response.

The vaccine was developed at the Public Health Agency of Canada’s National Microbiology Laboratory in Winnipeg and the Public Health Agency owns the intellectual property.
It has been licensed to NewLink Genetics of Ames, Iowa.
The company’s vice-president of business development says NewLink is finalizing the details to start the trial, which will involve injecting the vaccine into between 25 and 60 healthy volunteers.
The work will start in the United States, but Brian Wiley did not rule out the possibility that some of the work might be done in other countries as well.
“We are looking at options across the board but have not made any comment as to where those sites would be, whether they would be exclusively in the U.S. or outside the U.S.,” Wiley said in an interview Thursday.
The vaccine will be one of two that will begin to be tested in humans as early as next month.
On Thursday, the U.S. National Institutes of Health announced that they will begin a Phase 1 trial next week on an Ebola vaccine designed by scientists at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases.
The NIH is also providing support for the testing of the Canadian-made vaccine, known as VSV-EBOV. At least one of the trial sites for the VSV-EBOV study will be the clinical trials centre of the Walter Reed Army Institute of Research in Silver Spring, Md., Wiley says.
The German Centre for Infection Research has approached the Public Health Agency with an offer to test the vaccine in a small clinical trial. A spokesperson for the agency says the offer has been redirected to the World Health Organization.
But Wiley says NewLink will oversee the first human study of this vaccine, the so-called first-in-man trial.
He can’t estimate how quickly results might be forthcoming.
“Obviously the smoother it goes, the quicker we hope to get there,” Wiley says.
“But this is a first-in-man study so those are always very difficult to predict. We’re hoping to be able to move as swiftly as possible.”
Ebola expert Dr. Daniel Bausch welcomes the news that these trials are pushing ahead. And Bausch, an associate professor at Tulane School of Public Health and Tropical Medicine in New Orleans, La., says he’s glad both vaccines are being tested.
“We need all the tools we can get,” he says.
“You just never know how things are going to go. It is possible still that some of these products could have problems and safety issues and so if you put all your eggs in one basket ... and there’s a safety issue, then you’re just stuck.”
Up until now only one person has received the VSV-EBOV vaccine. In 2009, A German researcher pricked her finger with a needle which she had used to inject Ebola virus into a mouse.
That lab accident sparked a transcontinental effort to figure out which of the various experimental Ebola products could be given to the woman to improve her survival chances. A group of Ebola experts settled on the Canadian vaccine and a dose was flown by courier to Germany.
The woman survived. But it was not clear if that was due to the vaccine, which has been shown to be useful as a post-exposure tool in primate testing. It’s possible the virus never made its way into her bloodstream.
The unprecedentedly large Ebola outbreak raging in West Africa is fast-forwarding work on several potential Ebola vaccines and drugs that have been in early stages of development for years because of their limited market potential.
While Ebola outbreaks grab headlines, they are sporadic and rare. Before this outbreak fewer than 3,000 people had ever been known to have been infected with the virus, which first came to the world’s attention with the 1976 outbreak in Kitwit, Zaire (now the Democratic Republic of Congo).
Work in this field has been fuelled mainly by U.S. government funds funnelled through the Department of Health and Human Services’s Biomedical Advanced Research and Development Authority and the U.S. Defence Threat Reduction Agency.

More stories