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... ].
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(R) and PER.C6(R) 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 [at@JanssenGlobal ]@JanssenGlobal [https://twitter.com/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/participant... ] 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/inde... ] 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-upd...
iii. Wellcome Trust. Plotting the Course of Ebola Vaccines: Challenges and Unanswered Questions. March 2016.
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
