Global Public-Private Partnership Announces Publication of Positive Phase 1 Data for Ebola Vaccine Regimen in JAMA

London (ots/PRNewswire) -

First published clinical data show prime-boost Ebola vaccine
regimen produced an antibody response in 100 percent of healthy
volunteers that was sustained 8 months following immunization

An Ebola vaccine is still urgently needed to address the problem
of Ebola persistence in affected countries and to prevent future
outbreaks

Partners involved in the clinical program for the Ebola vaccine
regimen include the Janssen Pharmaceutical Companies of Johnson &
Johnson, the London School of Hygiene & Tropical Medicine, the
University of Oxford, Inserm, Bavarian Nordic and Europe's Innovative
Medicines Initiative

A public-private partnership of some of the world's leading health
organizations today announced that data from a Phase 1 study of a
preventive Ebola vaccine regimen have been published in JAMA: The
Journal of the American Medical Association. The results, the first
published on the vaccine regimen, suggest that the regimen was
well-tolerated by healthy volunteers and immunogenic (produced an
immune response). Among the findings, 100 percent of participants in
the study achieved an initial antibody response to Ebola, and this
response was sustained 8 months following immunization. The study was
led by the Oxford Vaccine Group at the University of Oxford
Department of Paediatrics and took place in the United Kingdom.

The Ebola vaccine regimen is being developed by the Janssen
Pharmaceutical Companies of Johnson & Johnson, in collaboration with
Bavarian Nordic. The regimen was first discovered in a collaborative
research program with the U.S. National Institutes of Health (NIH).
Clinical studies have been supported by grants awarded by Europe's
Innovative Medicines Initiative (IMI) to a consortium of leading
global research institutions working with Janssen, which includes the
London School of Hygiene & Tropical Medicine, the University of
Oxford and Inserm, the French National Institute of Health and
Medical Research.

"The Ebola crisis in West Africa left a huge human cost, we
continue to see flare-ups of this disease, and the world needs to be
far better prepared for the next major outbreak," said Paul Stoffels,
M.D., Chief Scientific Officer, Johnson & Johnson. "This study
suggests that Janssen's investigational prime-boost vaccine regimen,
if approved by regulators, could be an important tool in global
strategies to help prevent another Ebola epidemic."

The Phase 1 study tested a vaccine regimen containing two
components based on, respectively, AdVac® technology from Crucell
Holland B.V., one of the Janssen Pharmaceutical Companies, and
MVA-BN® technology from Bavarian Nordic A/S. Healthy volunteers were
given one vaccine dose to prime their immune system, and then the
alternative vaccine to boost their immune response, with the goal of
evaluating the duration of immunity. Prime-boost vaccination is an
established approach for the prevention of several infectious
diseases.

"Recent evidence highlighting the persistence of the Ebola virus
in bodily fluids, and the potential for sexual transmission from
Ebola survivors, reinforce the importance of finding a robust and
durable vaccine for this disease," said Dr. Matthew Snape of the
Oxford Vaccine Group and the study's lead author. "These results show
that an initial immune response with AdVac immunization is enhanced
by MVA-BN boosting, generating sustained immunity that has the
potential to provide durable protection from Ebola in at-risk
populations."

In the study, most participants were randomized in a blinded
fashion to receive either vaccine or placebo, while some individuals
were in an open-label group receiving vaccine. Among the randomized
participants, 97 percent generated antibodies specific to Ebola four
weeks after a priming dose with AdVac. Additionally, more than half
of AdVac recipients developed Ebola-specific T cells, a key marker of
cellular immunity. Validating the prime-boost concept, these immune
responses were enhanced by administration of the MVA-BN booster dose,
with 100 percent of participants generating Ebola-specific antibodies
at 21 days post-boost, and 79-100 percent showing T cell responses
depending on the dosing interval.

Notably, 8 months following prime vaccination, 100 percent of
individuals in the study maintained Ebola-specific antibodies, while
vaccine-induced T cell responses persisted in 77-80 percent of those
receiving the AdVac/MVA-BN regimen.

In terms of safety, injection site pain was the most common
reported adverse event, and was transient and generally of
mild-to-moderate severity. Among randomized participants, fever was
reported in 5 percent of AdVac recipients compared to 4.2 percent of
those receiving placebo. In the open-label group, 27 percent of
participants reported fever. All episodes of fever resolved within 24
to 48 hours. No serious vaccine-related adverse events were observed.

"Forty years after the discovery of Ebola, the world still needs
an approved vaccine for this disease," said Dr. Peter Piot, Director,
London School of Hygiene & Tropical Medicine. "A durable prime-boost
vaccine could be a vital asset in efforts to proactively protect the
general population in countries that are vulnerable to Ebola
outbreaks. And in light of the persistent challenges that we are
seeing with the Ebola virus, durability has become a particularly
important goal for vulnerable populations such as health workers and
the families of Ebola survivors."

"First of all, this study provides important validation for the
concept of a prime-boost vaccination strategy against this disease,"
said Yves Levy, CEO, Inserm. "Additionally, these data indicate that
the vaccine regimen can induce two types of immune response -
antibody-based and cellular - which together may have the potential
to confer long-term protection against Ebola. These results are
highly significant findings in the fight against Ebola in which
Inserm has been involved since the very beginning."

"We are delighted to see such positive results produced by a
consortium supported with grants from the Ebola+ programme," said
Ruxandra Draghia-Akli, Director, Health Directorate, European
Commission, and member of the IMI Governing Board. "These and the
many other Ebola studies underway with the European Commission and
IMI support show that cooperation research and public-private
partnerships can be formed with great speed to develop innovative
solutions for today's most pressing global health threats. Only by
joining forces as an international community can we prevent, control,
and end pandemics."

The Oxford study provides the first set of data from a total of 10
clinical studies that are being conducted on a parallel track across
the U.S., Europe and Africa in support of potential eventual
registration for the Ebola vaccine regimen. The first study of the
vaccine regimen in a West African country affected by the recent
Ebola outbreak began in Sierra Leone in October 2015.

The Ebola outbreak in West Africa began in March 2014 and put the
health care systems of Sierra Leone, Liberia and Guinea under
tremendous pressure. More than 28,600 individuals were infected with
the virus across the three countries, and more than 11,300 people
died - including more than 500 healthcare workers.[i] Unfortunately,
flare-ups of the disease continue in the region, most recently in
Guinea and Liberia, due to the persistence of the Ebola virus among
survivors.[ii] Healthcare and frontline workers are most at risk in
an Ebola outbreak and would benefit greatly from a durable
vaccine.[iii]

About the Phase 1 Study

This first-in-human Phase 1 study was a single-center, randomized,
placebo-controlled, observer-blind trial to assess the safety and
immunogenicity of an Ebola prime-boost vaccine regimen among healthy
adults. A total of 87 volunteers aged from 18 to 50 enrolled in the
United Kingdom from December 2014. Of these, 72 were randomized into
four groups of 18 receiving either Ad26.ZEBOV (AdVac) or MVA-BN-Filo
(MVA-BN) as prime. Participants then received a boosting dose with
the alternative vaccine 28 or 56 days later. Within each group
individuals were randomized 5:1 to receive study vaccines vs.
placebo. An open label group of 15 participants received AdVac
boosted by MVA-BN 14 days later. Follow-up on study participants
through 8 months was completed in October 2015 and an additional
follow-up analysis through 12 months is ongoing. Further details of
the study are posted on clinicaltrials.gov
(https://clinicaltrials.gov/ct2/show?term=Ad26.ZEBOV&rank=9).

About the Ebola Vaccine Regimen

Janssen's investigational Ebola vaccine regimen was developed 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 January 2015, Europe's Innovative Medicines Initiative (IMI)
awarded consortia of leading global research institutions and
non-government organizations working in conjunction with the Janssen
Pharmaceutical Companies grants totaling more than EUR100 million
from the Ebola+ programme to support the development, manufacturing
and deployment of the vaccine regimen.

The results of the Phase 1 data published in JAMA are generated
under grant agreement EBOVAC1 (grant nr. 115854). The IMI2 Joint
Undertaking receives support from the European Union's Horizon 2020
research and innovation program and European Federation of
Pharmaceutical Industries and Associations (EFPIA). Additionally, the
NIHR Oxford Biomedical Research Centre provides support to the Oxford
Vaccine Group, which conducted the Phase 1 study.

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.

Janssen in partnership with Bavarian Nordic rapidly scaled up
production of the vaccine regimen and now has approximately 2,000,000
regimens available, with the capacity to produce several million
regimens if needed.

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 127,100 employees
at more than 250 Johnson & Johnson operating companies work with
partners in health care to touch the lives of over a billion people
every day, throughout the world.

Our Commitment to Global Public Health

For 130 years, Johnson & Johnson has been committed to improving
the health of individuals, families and communities around the world,
including the most vulnerable populations. Today, our vibrant,
entrepreneurial and committed employees bring business acumen and
their collaborative spirit to help solve some of the most complex
global health problems. By harnessing our collective breadth and
scale, and our employees' passion and purpose, we strive to advance
health care and positively impact the lives of all people.

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 the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives by
finding new and better ways to prevent, intercept, treat and cure
disease inspires us. We bring together the best minds and pursue the
most promising science. We are Janssen. We collaborate with the world
for the health of everyone in it. Learn more at
http://www.janssen.com. Follow us at@JanssenGlobal

About the Oxford Vaccine Group

The Oxford Vaccine Group is an independent multi-disciplinary
clinical trials and epidemiology group based at the Centre for
Clinical Vaccinology and Tropical Medicine, University of Oxford. OVG
works towards the goal of developing new and improved vaccines for
the prevention of infection in adults and children. Current research
includes vaccines for chickenpox, salmonella typhi, flu, RSV and
Ebola. http://www.ovg.ox.ac.uk

About the London School of Hygiene & Tropical Medicine

The London School of Hygiene & Tropical Medicine is a
world-leading center for research and postgraduate education in
public and global health, with more than 4,000 students and 1,000
staff working in over 100 countries. The School is one of the
highest-rated research institutions in the UK, and among the world's
leading schools in public and global health. Our mission is to
improve health and health equity in the UK and worldwide; working in
partnership to achieve excellence in public and global health
research, education and translation of knowledge into policy and
practice. http://www.lshtm.ac.uk

About Inserm

Founded in 1964, the French National Institute of Health and
Medical Research (Inserm) is a public science and technology
institute, jointly supervised by the French ministry of education,
higher education and research and the ministry of social affairs,
health and women's rights. Ranked as the number one academic research
institution in biomedical research in the European Union, Inserm
supports more than 300 laboratories across France. In total, the
teams include nearly 13,000 researchers, engineers, technicians and
administrative staff. The mission of these scientists is to study all
diseases, from the most common to the rarest, through their work in
biological, medical and public health research. http://www.inserm.fr

About the European Commission and Ebola research

Joining forces with industry to combat Ebola - EUR215 million of
research funding for Ebola and related viruses has been mobilised by
the Innovative Medicines Initiative (IMI), a partnership between the
European Commission and the pharmaceutical industry in Europe. EUR114
million comes from Horizon 2020, and the remaining EUR101 million
from the pharmaceutical companies involved in the projects. Work on
these projects began already in January 2015, involving the clinical
development of new vaccines against Ebola, as well as vaccine
production and the development of fast diagnostic tests. The IMI2
Ebola+ programme (http://ec.europa.eu/research/participants/portal/de
sktop/en/opportunities/h2020/topics/11097-imi2-2015-08.html)
continues to further strengthen research on Ebola. In addition, the
European Commission has launched many other important research
actions (http://ec.europa.eu/research/health/index.cfm?pg=area&areana
me=ebola) on Ebola.

i. WHO Ebola Situation Reports. Accessed March 31, 2016.
http://apps.who.int/ebola/ebola-situation-reports

ii. WHO Update from the Field. Liberia and Guinea step up
coordination to stem new cases of Ebola. April 7, 2016. Accessed
April 11, 2016.
http://who.int/csr/disease/ebola/liberia-guinea-flareups-update/en/

iii. Wellcome Trust. Plotting the Course of Ebola Vaccines:
Challenges and Unanswered Questions. March 2016.

ots Originaltext: EBOVAC1
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Contact:
Seema Kumar (J&J
Global)
+1-908-405-1144

Daniel De Schryver (J&J
Europe)
+49 173 76 89 149

Thomas Mooney (LSHTM)
+232(0)79-129-903

Thomas Calver (Oxford University)
+44(0)1865-270046