GlaxoSmithKline, NIH Report Positive Ebola Vaccine Phase 1 Trial
December 1, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
GlaxoSmithKline and the National Institutes of Health have seen promising results from an Ebola vaccine candidate and will speed the new drug into the next phase of clinical trials as soon as next month, the company said last week.
The results for the monovalent vaccine were published in the New England Journal of Medicine and the agency has said that it now hopes to begin testing the vaccine on healthcare workers and other groups at high risk for infection as soon as January.
Drugmakers and regulators worldwide have been rushing to find a vaccine or cure for Ebola as the epidemic continues.
The monovalent vaccine was tested on 20 American volunteers this fall and all 20 developed antibodies against Ebola, with no side effects, said the clinical paper. The volunteers ranged in age from 18 to 50 and were split into two groups, with half receiving an intramuscular injection of vaccine at a lower dose, and 10 receiving the vaccine at a higher dosage level. All 20 then developed antibodies within four weeks of receiving the vaccine, and those given the higher-dose vaccine had more antibodies.
That bodes well for the future of the vaccine, which is meant to help end the Ebola epidemic raging in West Africa, where at least 5,689 people have died, though the actual number is thought to be much higher, said experts.
“We are very encouraged by these positive first trial results showing this type of vaccine has an acceptable safety profile and can produce an immune response against Ebola in humans,” said Moncef Slaoui, chairman of global vaccines at GSK, in a statement.
“It’s important to remember that these data are the first piece in the jigsaw and we’re continuing to gather other important information,” he said. “Over the coming weeks, we will see results from further phase 1 trials which will tell us more about the profile of the monovalent vaccine; most significantly results from a trial in Mali which is assessing its safety and immune response in West African populations.”