TOPIC
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Ebola
vaccine passes safety test in Geneva trial
APR 1, 2015 -
23:00
The experimental
Ebola vaccine partially tested at Geneva University Hospital (HUG) is safe and
effective, results show. Attention now turns to follow-up trials in West Africa
in the race to find a cure.
According to the
results of the phase one clinical trial carried out at the HUG and at partner
institutions in Europe and Africa, one of the most promising vaccine
candidates, VSV-ZEBOV, triggers the production of antibodies capable of
neutralising the Ebola virus.
These results,
published on Wednesday in the New England Journal of Medicine, were based on 158 volunteers
who participated in the trials that begun in November 2014.
Most of the side
effects from the vaccine were only “mild to moderate”, such as fever and muscle
pain for one or two days.
The vaccine was
developed by Canada’s public health agency and is licensed to two US companies,
NewLink and Merck. The product had previously been tested on monkeys. Several
other experimental vaccine candidates are currently in the pipeline at
different stages of development.
Vaccines
normally take years to develop, but the process has been fast-tracked due to
the urgency. The current Ebola outbreak in West Africa has killed more than
10,300 people.
“It was a race
against time,” explained Claire-Anne Siegrist, principal investigator and head
of the vaccinology centre at the HUG.
“On September 10
we officially accepted the mandate from the World Health Organization (WHO).
One month later the protocol was ready and submitted to Swissmedic [the Swiss
Agency for Therapeutic Products] and one month later we had the authorisation
to start the vaccination trial. I've never seen that before. It's not possible
to go any faster.”
African trials
Attention now
turns to West Africa: Guinea, Sierra Leone and Liberia. Phase three clinical
trials recently launched there will determine whether the immune response
triggered by vaccines like VSV-ZEBOV is able to protect the population against
the Ebola virus, and whether large-scale campaigns are feasible.
Liberia has
largely succeeded in getting its Ebola outbreak under control and was on its
way to completing the 42 days without a new case – necessary to declare the
country free of the disease – when it recorded one infection last month.
Sierra Leone has
seen a fairly steady decline in cases in recent weeks. But the disease remains
stubbornly entrenched in Guinea more than a year after the outbreak started and
authorities are now stepping up efforts to eliminate the disease.
“The question is
not resolved,” said Laurent Kaiser, head of the infectious diseases department
at HUG. “Most new cases have not been identified as coming from an established
chain of transmission, which poses lots of problems. The epidemic is clearly
not under control and another reason to advance with the vaccine.”
‘Excellent response’
Last week the US
National Institutes of Health reported that two experimental Ebola vaccines,
one from GlaxoSmithKline and the other from Merck/NewLink, “appear to be safe”
part way through a clinical trial being conducted in Liberia, which began on
February 2.
In neighbouring
Guinea, testing also started using the experimental Ebola vaccine VSV-ZEBOV on
affected communities last week. The WHO plans to vaccinate around 10,000
people. Health workers will immunise the high-risk contacts around Ebola
patients, thereby creating a “ring of immunity” around them. The vaccine has
already been administered to some volunteer healthcare workers. The WHO said
the first teams had received an “excellent response” from residents.
If the number of
Ebola cases holds steady or increases, the WHO believes the Guinea study could
be completed in six to eight weeks. But if the cases sharply decline, the
outcome of the trial could encounter difficulties. Experiments need scores of
patients with the virus in order to produce statistically significant results.
Vaccine tests
are due to start on 5,000-6,000 front-line health workers in Sierra Leone this
month.
SUMMARY
OF THE TOPIC
An experimental Ebola vaccine tested
on humans in Europe and Africa sparks the production of the antibodies needed
to neutralise the deadly virus.
There is no licensed treatment or
vaccine for Ebola, and the World Health Organization last year endorsed rushing
potential ones through trials in a bid to stem the epidemic still simmering in
west Africa.
That results, published on Wednesday
in the New England Journal of Medicine, were based on 158 volunteers who
participated in the trials that begun in November 2014.
Initial clinical trials of the
VSV-ZEBOV candidate vaccine, manufactured by the Public Health Agency of Canada
and developed by Merck, show that it "triggers the production of
antibodies capable of neutralising the Ebola virus," the Geneva University
Hospitals (HUG) said in a statement.
A study of the phase 1 clinical trials
on 158 volunteers in Switzerland, Germany, Gabon and Kenya, published in the
New England Journal of Medicine, also showed that the even small amounts of the
vaccine could be effective.
Since the Ebola outbreak began in
Guinea, the current Ebola outbreak in West Africa has killed more than 10,300
people.
Most of the side effects from the
vaccine were only “mild to moderate”, such as fever and muscle pain for one or
two days.
Liberia has largely succeeded in
getting its Ebola outbreak under control and was on its way to completing the
42 days without a new case – necessary to declare the country free of the
disease – when it recorded one infection last month.
Last week the US National Institutes
of Health reported that two experimental Ebola vaccines, one from
GlaxoSmithKline and the other from Merck/NewLink, “appear to be safe” part way
through a clinical trial being conducted in Liberia, which began on February 2.
In neighbouring Guinea, testing also
started using the experimental Ebola vaccine VSV-ZEBOV on affected communities
last week. The WHO plans to vaccinate around 10,000 people. Health workers will
immunise the high-risk contacts around Ebola patients. The vaccine has already
been administered to some volunteer healthcare workers. The WHO said the first
teams had received an excellent response from residents.
If the number of Ebola cases holds
steady or increases, the WHO believes the Guinea study could be completed in
six to eight weeks. But if the cases sharply decline, the outcome of the trial
could encounter difficulties. Experiments need scores of patients with the
virus in order to produce statistically significant results.
Vaccine tests are due to start on
5,000-6,000 front-line health workers in Sierra Leone this month.
GRAMMAR
