NEW BRUNSWICK, N.J.,
Oct. 9, 2015 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) today announced the start of a safety and
immunogenicity clinical trial in Sierra
Leone of a preventive Ebola vaccine regimen in development
at its Janssen Pharmaceutical Companies. Trial recruitment is
underway, and the first volunteers have received their initial
vaccine dose. This is the first study conducted of Janssen's Ebola
prime-boost vaccine regimen in a West African country affected by
the recent Ebola epidemic.
The new study, EBOVAC-Salone, will take place in Sierra Leone's Kambia district, where some of
the country's most recent Ebola cases have been reported. The
regimen being tested uses a combination of two vaccine components
based on AdVac® technology from Crucell Holland B.V., one of the
Janssen Pharmaceutical Companies, and MVA-BN® technology from
Bavarian Nordic. Volunteers in the study will first be given the
AdVac dose to prime their immune system, and then the MVA-BN dose
two months later to boost their immune response, with the goal of
potentially strengthening and optimizing the duration of the
immunity.
"Never again can Ebola be allowed to cause the human suffering
that the world has witnessed in West
Africa and we remain committed as ever to helping the
international community combat this disease," said Paul Stoffels, M.D., Chief Scientific Officer
and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson.
"One of the many lessons learned from the outbreak is we cannot let
our guard down with Ebola, and we need to test every promising
prevention tool. It is our hope that this study will help to
confirm the value of this vaccine regimen in Ebola control efforts
– not just for Sierra Leone, but
for the world."
Since announcing its commitment to combat Ebola in October 2014, Johnson & Johnson has mobilized
significant resources to advance the research and development of an
Ebola vaccine regimen with the goal of addressing the urgent public
health need of affected countries such as Sierra Leone. With this goal in mind, in 2015
Janssen developed partnerships and consortia with other companies
and research institutions, secured funding from European and U.S.
public authorities, and launched multiple Phase I and II studies in
rapid succession across the U.S., Europe and Africa. Additionally, Janssen in partnership
with Bavarian Nordic, rapidly scaled up production of the vaccine
regimen to more than 800,000 regimens, with the capacity to produce
a total of 2 million regimens as needed.
Professor Peter Piot, M.D.,
Director of the London School of Hygiene & Tropical Medicine,
which is one of the partners conducting the study, said: "We cannot
afford to be complacent about Ebola. We urgently need a vaccine
that offers long-term protection of the population, including
health workers and other care givers, in order to prevent a
resurgence of the virus. To achieve this goal, it is vital to test
a range of vaccine candidates, particularly in the areas affected
by the epidemic where we are still seeing new cases emerging, and
there is evidence that the infection may have longer-term effects
among survivors. Prime-boost vaccination is an effective strategy
for long-term prevention of several infectious diseases, and we
believe it may have a key role to play in the fight against
Ebola."
The EBOVAC-Salone study is notable in that it will evaluate the
vaccine regimen's safety and immune response within the general
population of Sierra Leone,
including vulnerable groups such as adolescents, children, and
people with HIV. In addition to the London School of Hygiene &
Tropical Medicine which is coordinating the EBOVAC-Salone trial,
Janssen is partnering with Sierra
Leone's Ministry of Health and Sanitation, the College of
Medicine and Allied Health Sciences, and two consortia of which
Janssen is a member that are funded by Europe's Innovative Medicines Initiative
(IMI): EBOVAC1 (Ebola Vaccine Development), which is conducting the
study, and EBODAC (Ebola Vaccine Deployment, Acceptance &
Compliance), which is developing a communication strategy and tools
to promote the acceptance and uptake of the Ebola vaccine
regimen.
From the outset, the EBOVAC-Salone team's goal has been to
conduct a study that meets Sierra
Leone's Ebola prevention needs, has the support of the
Sierra Leonean people, and can play a sustaining role in helping to
restore the country's health infrastructure following the Ebola
outbreak. Significant investment has been made to build new
facilities in Kambia to conduct the study, which will contribute
substantially to the strengthening of the local health system.
These include establishing the first Emergency Room at the Kambia
District Hospital, and building a new vaccine storage facility on
the hospital site. These efforts are complemented by the employment
and training of doctors, nurses and other frontline health care
workers who will gain valuable experience while contributing to the
clinical study.
"Defeating this Ebola outbreak has been a long and difficult
journey for everybody in Sierra
Leone," said Professor Monty
Jones, Special Adviser on Ebola to the President of
Sierra Leone. "Studying vaccines
here in Sierra Leone will help us
to secure our own future against the disease, and is also a proud
contribution from Sierra Leone to
the rest of the world."
The EBOVAC-Salone study is being initiated on a parallel track
with multiple ongoing Phase I and II studies that are being
conducted across the U.S., Europe
and Africa as part of the
accelerated development plan for the Ebola vaccine regimen.
First-in-human Phase I clinical studies of the prime-boost vaccine
regimen began in the United
Kingdom and United States
in January 2015, followed by several
sites in Africa. In May 2015, Johnson & Johnson presented
promising preliminary data from the UK Phase I study to the U.S.
Food and Drug Administration (FDA). A Phase II study, being carried
out in the UK and France, started
in July 2015, and a second multi-site
Phase II study will shortly commence in several West and East
African countries in outside epidemic areas. These Phase II studies
are being coordinated by Institut National de la Sante et de la
Recherche Medicale (Inserm), another consortium partner with
Janssen.
To date, there is no licensed vaccine, treatment or cure for the
Ebola virus. The Ebola outbreak in West
Africa began in March 2014 and
has put the health care systems of Sierra
Leone, Liberia and
Guinea under tremendous pressure.
As of October 2015, over 28,400
people have been infected with the virus across the three
countries, and nearly 11,300 have died – including more than 500
health care workers. In Sierra
Leone specifically, nearly 14,000 cases of Ebola have been
reported and nearly 4,000 people have died.i
About the EBOVAC-Salone Study
EBOVAC-Salone is a clinical trial to assess the safety and
immunogenicity of an Ebola prime-boost vaccine regimen among
adults, adolescents and children in Sierra Leone who volunteer to participate.
Volunteers are planned to enroll in the study at different stages
over the course of several months. In stage 1 of the study,
approximately 40 adults aged 18 years or older will be vaccinated
to gain information about the safety and immunogenicity (immune
response) of the prime-boost regimen. In stage 2, a larger group of
approximately 400 individuals will be vaccinated to further
evaluate the safety and immunogenicity of the vaccine regimen
across different age groups. In this stage, adolescents and
children will be included. Additional stages are being finalized in
consultation with the Sierra Leonean authorities and international
health agencies. Further details of the study are posted on
clinicaltrials.gov.
In January 2015, Europe's Innovative Medicines Initiative (IMI)
awarded a consortia of leading global research institutions and
non-government organizations working in conjunction with the
Janssen Pharmaceutical Companies grants totaling more than €100
million from the Ebola+ programme to support the development,
manufacturing and deployment of the vaccine regimen.
Janssen's EBOVAC1 and EBODAC consortia partners also include the
University of Oxford, Inserm, Grameen
Foundation and World Vision of Ireland. The Innovative Medicines Initiative 2
Joint Undertaking is under grant agreement EBOVAC1 (grant nr.
115854) and EBODAC (grant nr. 115847), part of the Ebola+ program
launched in response to the Ebola virus disease outbreak. This IMI2
Joint Undertaking receives support from the European Union's
Horizon 2020 research and innovation programme and European
Federation of Pharmaceutical Industries and Associations
(EFPIA).
About the Ebola Vaccine Regimen
Janssen's
investigational Ebola vaccine regimen was discovered in a
collaborative research program with the National Institutes of
Health (NIH). This program received direct funding and
preclinical services from the National Institute of Allergy and
Infectious Diseases (NIAID), part of NIH, under Contract Numbers
HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I,
respectively. The MVA-BN-Filo material used in phase 1 studies was
produced under NIAID/Fisher BioServices contract #FBS-004-009 and
NIH contract HHSN272200800044C.
In September 2015, Crucell Holland
B.V., one of the Janssen Pharmaceutical Companies, was awarded
$28.5 million from The Biomedical
Advanced Research and Development Authority (BARDA), part of the
U.S. Department of Health and Human Services, to help accelerate
the development of the prime-boost vaccine regimen.
About Johnson's & Johnson's Commitment on
Ebola
In addition to accelerating development of the
vaccine regimen, Johnson & Johnson engaged in a range of
philanthropic efforts to support organizations leading Ebola
prevention and control efforts including Direct Relief
International, Partners in Health, AmeriCares, IntraHealth and
Project HOPE. The company also supports ongoing efforts by public
health authorities, including the U.S. Centers for Disease Control
and Prevention (CDC) and the World Health Organization (WHO), to
mount a coordinated world response to address the immediate needs
raised by the Ebola outbreak. As part of its commitment to support
nurses, Johnson & Johnson gave an educational grant to
Nurse.com to make available to every nurse in the U.S. continuing
education resources about Ebola.
About Johnson & Johnson
Caring for the
world one person at a time…inspires and unites the people of
Johnson & Johnson. We embrace research and science - bringing
innovative ideas, products and services to advance the health and
well-being of people. Our approximately 127,000 employees at more
than 265 Johnson & Johnson operating companies work with
partners in health care to touch the lives of over a billion people
every day, throughout the world.
About Crucell
Crucell Holland B.V. is one of
the Janssen Pharmaceutical Companies of Johnson & Johnson, and
is focused on research, development and production of
vaccines that prevent and/or treat infectious diseases. Crucell has
a broad development pipeline, with several product candidates based
on its unique AdVac® and
PER.C6® production technology.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we are dedicated to addressing
and solving some of the most important unmet medical needs of our
time in infectious diseases and vaccines, oncology, immunology,
neuroscience, and cardiovascular and metabolic diseases. Driven by
our commitment to patients, we develop innovative products,
services and health care solutions to help people throughout the
world.
Cautions Concerning Forward-Looking
Statements
(This press release contains
"forward-looking statements" as defined in the Private Securities
Litigation Reform Act of 1995, including regarding development of
an Ebola vaccine. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on
current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of the Janssen Pharmaceutical
Companies and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product development, including the
uncertainties of clinical success and the timeline for the
availability of a potential vaccine against Ebola; technological
advances and new products attained by competitors; the challenges
and risks involved in large-scale production of a vaccine; and the
uncertainty of the level of demand for a vaccine against
Ebola. A further list and description of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 29, 2013, including in
Exhibit 99 thereto, and the company's subsequent filings with the
Securities and Exchange Commission. Copies of these filings are
available online at
www.sec.gov, www.jnj.com or on
request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new
information or future events or developments.)
i WHO Ebola Situation Reports. Accessed October 8, 2015.
http://apps.who.int/ebola/ebola-situation-reports
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