January 29, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Scientists at Oxford University said on Wednesday that results from the Phase I trial of GlaxoSmithKline ’s candidate Ebola vaccine suggest the vaccine is safe for humans and does generate an immune response.
“The vaccine was well tolerated. Its safety profile is pretty much as we had hoped,” said Adrian Hill of the Jenner Institute at Oxford University, who led the trial, in a statement.
The U.S. National Institutes of Health (NIH) and GSK are co-developing the candidate Ebola vaccine, which targets the Zaire species of Ebola that is currently affecting West Africa. The NIH supplied the UK trial, which is funded by the Wellcome Trust, Medical Research Council (MRC) and Department for International Development (DFID), with the candidate vaccine.
The study results were published in the New England Journal of Medicine on Wednesday. The paper reports the initial results of the trial that involves 60 healthy volunteers who were vaccinated at the Jenner Institute between Sept. 17 and Nov. 18. The data published in the paper includes the safety and immune responses of the volunteers for the 28 days following vaccination.
In the trial, 20 volunteers received a low dose vaccine; 20 volunteers received a middle dose; and 20 volunteers received a high dose. “People typically experienced mild symptoms that lasted for one or maybe two days, such as pain or reddening at the injection site, and occasionally people felt feverish,” said Hill in a statement. “It’s very similar to what has been seen in previous studies with this general type of vaccine.”
While the safety of the vaccine is paramount, it must also protect people against the Ebola virus. In order to measure the vaccine’s potential to do this, scientists recorded the immune responses against Ebola caused by the vaccine. It is important to note that the vaccine tested cannot cause a person to become infected with Ebola because the vaccine does not contain infectious Ebola virus material.
“The results are very encouraging in terms of the safety profile of the vaccine. That is the main outcome from this trial,” said Hill. “We have seen an immune response in the great majority of people receiving the vaccine. It is possible to be optimistic about the immune responses we’ve seen; it’s also hard to be really confident the levels would be protective. Larger trials in West Africa will be able to tell us more. We are also currently assessing another option, involving a booster dose, for improving immune response levels.”
The vaccine generated a lower antibody response in humans than in macaque monkeys who received the same vaccine. In addition T-cell response was also much lower in human volunteers than in the macaques. The concern, however, is that scientists do not know what level of immune response will protect humans, so they do not yet know how to assess the level of immune response observed in humans who received the vaccine.
“Whether we have a vaccine that is safe, effective and works, we won’t know for a while yet,” Hill said. “But we owe it to the people who have been affected so badly by the Ebola outbreak to find out.”
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