GlaxoSmithKline Plc (GSK)’s Ebola vaccine
produced responses from the immune system and didn’t raise
safety concerns in a study with 20 healthy adults, completing an
initial step toward making it widely available.
The participants in the early-stage clinical trial in
Maryland all produced antibodies, according to a preliminary
report published yesterday in the New England Journal of
Medicine. Two participants developed brief fevers within a day
of vaccinations, but there were no serious adverse effects.
“It’s good news,” said Anthony Fauci, director of the
U.S. National Institute of Allergy and Infectious Diseases,
which is developing the vaccine with Glaxo. “If it was very
toxic or didn’t induce good immune response, we couldn’t go on
to the next step, but the proof of the pudding is efficacy.”
The tests showed that trial participants’ immune systems
responded similarly to animals that gained protection from the
virus after getting the vaccine, Fauci said. “It did what I
hoped it would do.”
Glaxo and drugmakers including NewLink Genetics Corp. and
Johnson Johnson are racing to create a vaccine as the Ebola
outbreak in West Africa continues to spread, with more than
15,000 infections and more than 5,600 deaths so far, according
to the World Health Organization.
More Trials
The Glaxo product will still require more trials to show
it’s effective. The vaccine, based on a chimpanzee virus,
carries genetic material from two strains of the Ebola virus.
The vaccine can’t infect people with Ebola. Instead, it teaches
the body to recognize Ebola and prepares the immune system to
attack it in case of an infection.
Besides producing antibodies that specifically recognize
Ebola, trial participants also produced more of a specific type
of T-cell that is part of the body’s mechanism to hunt and kill
viruses. Four weeks after being vaccinated, the killer T-cells
were detected in two volunteers who received the lower dose and
seven who got the higher dose.
The results show that the higher dose should be used, said
Fauci by telephone.
“We are very encouraged by these positive first trial
results,” Moncef Slaoui, Glaxo’s chairman of global vaccines,
said 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.”
Liberia Trial
An efficacy trial with thousands of participants will begin
in Liberia sometime in January, said Fauci. The subjects will
receive either a placebo, NewLink’s vaccine, or Glaxo’s, and
infection rates in the three groups will be compared to
determine which works best.
In the meantime, additional safety trials of Glaxo’s
vaccine are running in Switzerland, the U.K. and Mali, according
to the U.S. National Institutes of Health.
Data from NewLink’s safety trial should be ready by mid-December, said Fauci. NewLink said this week it will work with
Merck Co. to have the vaccine available for late-stage testing
by early next year.
JJ plans to have 250,000 doses of its experimental Ebola
vaccine ready for clinical trials in May, the company said last
month.
To contact the reporter on this story:
Caroline Chen in New York at
cchen509@bloomberg.net
To contact the editors responsible for this story:
Crayton Harrison at
tharrison5@bloomberg.net
Drew Armstrong
Article source: http://www.dailymail.co.uk/wires/ap/article-2840600/China-school-bus-crash-kills-11-kindergarteners.html
GlaxoSmithKline Plc (GSK)’s Ebola vaccine
produced responses from the immune system and didn’t raise
safety concerns in a study with 20 healthy adults, completing an
initial step toward making it widely available.
The participants in the early-stage clinical trial in
Maryland all produced ant...
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