The Data and Safety Monitoring Board, the independent body of international experts that reviews these cases, said the trial should continue – a move approved by the national regulatory authority and ethics review committee.
Results from the clinical trial were published Friday in the British medical journal The Lancet. The next step is to determine whether the vaccine can protect people through “herd immunity,” or finding out what percentage of people need to be vaccinated so that the chances of spreading a disease are low.
Assistant Director-General Marie-Paule Kieny, who leads the Ebola Research and Development effort at WHO, said in a statement that the work marked a turning point in thae history of research and development. “We now know that the urgency of saving lives can accelerate R and D,” she said.
“We will harness this positive experience to develop a global R and D preparedness framework so that if another major disease outbreak ever happens again, for any disease, the world can act quickly and efficiently to develop and use medical tools and prevent a large-scale tragedy.”
The vaccine used in the Guinea study is called VSV-EBOV, which WHO describes as a “good” microorganism that has borrowed the guise of the Ebola virus but does not contain the virus. It tricks the body of the vaccinated person and triggers an immune defense against the Ebola virus, protecting the person if they come into contact with someone who is infected.
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The vaccine was developed by the Public Health Agency of Canada and NewLink Genetics USA and is manufactured by Merck Vaccines in the U.S.
The testing method in Guinea was similar to that of smallpox, called a “ring” vaccination method. It works by vaccinating people who have come into contact with an infected person, by creating a protective “ring” and stopping the virus from spreading.
Until now, half of the rings were vaccinated three weeks after someone with Ebola had been identified, and were compared with rings vaccinated immediately. Ebola symptoms – which include fever, diarrhea and vomiting – can begin three weeks after coming into direct contact with someone who is infected.
“This strategy has helped us to follow the dispersed epidemic in Guinea, and will provide a way to continue this as a public health intervention in trial mode,” said John-Arne Røttingen, Director of the Division of Infectious Disease Control at the Norwegian Institute of Public Health and Chair of the Study Steering Group.
This is an alternative method to using a placebo by providing a randomized control group for comparison, but also ensures that all contacts are vaccinated within the trial, according to WHO.
More than 4,000 volunteers participated in the three trial stages, meant to determine first whether the vaccine is safe, then whether it works in protecting people from getting Ebola.
WHO says the trial will now include teens and children, given evidence of the vaccine’s safety. Side effects have included flu-like symptoms and joint pain, both of which go away after a few hours or days.
ref:usnews
