Saturday 29 November 2014

GSK Announces Success On Ebola Trial Vaccine

GSK announces success on Ebola trial vaccine


GlaxoSmithKline has announced an initial success on phase 1 trial of
an Ebola vaccine.

The first results from the trial published on Thursday in the New
England Journal of Medicine showed that a GSK and National Institute
of Health Ebola candidate vaccine was well-tolerated and produced an
immunological response in each of the 20 healthy adult volunteers in
the United States who received it.

In a statement released on Thursday by the pharmaceutical company,
the vaccine used in the trial conducted by the NIH was co-developed
by the institute’s National Institute of Allergy and Infectious Diseases
and Okairos, a biotechnology company acquired by GSK in 2013.

The statement read in part, “It uses a type of chimpanzee cold virus,
known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to
deliver genetic material from two strains of the Ebola virus – the
Sudan strain and the Zaire strain, which is responsible for the current
Ebola outbreak in West Africa.

“GSK has been working with the NIH to accelerate development of
both this bivalent version of the candidate vaccine and a monovalent
version targeting only the Zaire strain in response to the current Ebola
epidemic.”

Commenting on the results, Chairman of Global Vaccines at GSK, Dr.
Moncef Slaoui, said, “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.

Working with partners including the NIH, we’re doing all we can to
advance development of a candidate vaccine in response to the Ebola
crisis in West Africa.

“It’s important to remember that these data are the first piece in the
jigsaw and we’re continuing to gather other important information.
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.

“If the combined data from these trials are positive, the next phases
of the clinical trial programme will begin in early 2015 to see whether
the immune response we are seeing in phase 1 actually translates into
providing people in affected countries with meaningful protection
against Ebola.”

Slaoui added that the phase 3 trials would involve the vaccination of
thousands of volunteers, including frontline health-care workers in
affected countries, including Liberia and Sierra Leone, and possibly
Guinea.

“If the candidate vaccine is able to protect these healthcare workers
as we hope it will, it could significantly contribute to efforts to bring
this epidemic under control,” he noted.

Agency report

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