In Interim Results from Phase 3 Study, Merck’s Investigational Ebola Vaccine Efficacious; Study is Continuing
July 31 2015 - 8:10AM
Business Wire
Global Collaboration Enabled Vaccine to Move
from First-in-Human Studies to Initial Phase 3 Results Within One
Year
Merck (known as MSD outside the US and Canada) said today that
its investigational Ebola vaccine candidate, rVSV-ZEBOV, was found
to have 100 percent efficacy in an analysis of interim data from a
Phase 3 ring vaccination trial in Guinea. Preliminary conclusions
from this study, which is continuing, were published on-line today
in The Lancet. The authors report that vaccine efficacy was 100
percent (95% confidence interval: 74.7 - 100%; p=0.0036) following
vaccination with a single dose of the rVSV-ZEBOV vaccine. It
appeared that all vaccinated individuals were protected against
Ebola virus infection within 6 to 10 days of vaccination.
To date, more than 4,000 participants have received the vaccine
in this innovative trial, called “Ebola ça suffit” or “Ebola,
that’s enough.” The trial was conducted by a team that included
researchers from the World Health Organization (WHO), the Norwegian
Institute of Public Health, the Health Ministry of Guinea and
Médecins sans Frontières, among others. The results from this
continuing study, as well as other studies already underway (see
below) and additional studies to be conducted, will be used to
support worldwide regulatory submissions.
“Merck has an enduring commitment to develop vaccines and
medicines that address the world’s most devastating infectious
diseases,” said Dr. Roger M. Perlmutter, president of Merck
Research Laboratories. “Building on pioneering early work by the
Public Health Agency of Canada and NewLink Genetics Corporation,
the extraordinary efforts of the team in Guinea and other experts
have yielded interim results that suggest a potential role for our
rVSV-ZEBOV vaccine in the fight against Ebola disease.”
About the development of the rVSV-ZEBOV vaccine
The rVSV-ZEBOV vaccine was initially engineered with support
from the Public Health Agency of Canada and was licensed to NewLink
Genetics Corporation. To make the vaccine, the vesicular stomatitis
virus was weakened by removing one of its genes, which was then
replaced with a single Ebola virus gene that cannot cause disease
by itself. Vaccinated individuals have been shown to develop
antibodies against the Ebola virus, which could help protect
against future infection. The significance and durability of this
immune response have not been determined.
In late 2014, when the current Ebola outbreak was at its most
severe, Merck licensed rVSV-ZEBOV from NewLink Genetics, with the
goal of accelerating the assessment of this candidate vaccine.
Since that time, Merck has helped to enable a broad development
program, including the interim phase 3 efficacy results released
today. To date, the rVSV-ZEBOV vaccine has been administered to
more than 9,000 people in phase 1, 2 and 3 clinical trials.
In addition to NewLink and the Public Health Agency of Canada,
leading global and national health organizations including the
National Institute of Allergy and Infectious Diseases (NIAID), the
Walter Reed Army Institute of Research (WRAIR), the Canadian
Immunization Research Network (CIRN) and the US Army Medical
Research Institute of Infectious Diseases (USAMRIID) have helped to
conduct studies of the rVSV-ZEBOV vaccine. Major funders for these
studies included the US Department of Defense’s (DoD) Defense
Threat Reduction Agency (DTRA) and Joint Vaccine Acquisition
Program (JVAP), the US Department of Health and Human Service’s
Biomedical Advanced Research Development Authority (BARDA), the
National Institutes of Health (NIH) and the Wellcome Trust.
In addition to the phase 3 trial in Guinea described above,
other studies evaluating the rVSV-ZEBOV vaccine include the STRIVE
(Sierra Leone Trial to Introduce a Vaccine against Ebola) phase 3
study currently being conducted by the Sierra Leone College of
Medicine and Allied Health Sciences (COMAHS), Sierra Leone Ministry
of Health and Sanitation and the US Centers for Disease Control and
Prevention (CDC); and the PREVAIL (Partnership for Research on
Ebola Vaccines in Liberia) phase 2 study being conducted by a
Liberia-NIH partnership in Liberia.
Merck is responsible for research, development and manufacturing
efforts in support of the rVSV-ZEBOV vaccine. Merck has committed
to work closely with other stakeholders to accelerate the continued
development, production and, if licensed, distribution of the
vaccine.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
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