Based on final Phase 1 data published in JAMA, prime-boost Ebola vaccine regimen induced antibody response that persisted in 100 percent of healthy volunteers to at least 1 year following vaccination
Vaccine development partners include U.S. National Institutes of Health, Europe’s Innovative Medicines Initiative, Bavarian Nordic, London School of Hygiene & Tropical Medicine, University of Oxford, Inserm and BARDA
NEW BRUNSWICK, N.J., March 14, 2017 – Johnson & Johnson announced that final Phase 1 clinical trial data published in JAMA: The Journal of the American Medical Association show that Janssen Pharmaceutical Companies’ investigational “prime-boost” Ebola vaccine regimen induced a durable immune response in 100 percent of healthy volunteers one year following vaccination.
The Phase 1 study was led by the Oxford Vaccine Group at the University of Oxford. It tested the prime-boost Ebola vaccine regimen being developed by Janssen Vaccines & Prevention B.V. that is based on Janssen’s AdVac® technology and MVA-BN® technology from Bavarian Nordic A/S. Healthy volunteers were given one vaccine dose to prime their immune system, and the alternative vaccine to boost their immune response. Additional Phase 1, 2 and 3 studies are ongoing to confirm these findings.
“The world needs a vaccine to help prevent or mitigate future Ebola outbreaks, and ideally it should provide sustained protection for at-risk populations,” said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson. “We are committed to helping the global community finish the job of finding an Ebola preventive vaccine. Together with our EBOVAC1 consortium partners the London School of Hygiene & Tropical Medicine, University of Oxford, and Inserm, we are grateful for the ongoing support of Europe’s Innovative Medicines Initiative (IMI), BARDA and NIH. Additionally, we will work with new mechanisms like the Coalition for Epidemic Preparedness Innovations (CEPI), as well as regulators and other key stakeholders, to forge a path forward to protect global health.”
Recent evidence highlighting the persistence of the Ebola virus in bodily fluids, and the potential for sexual transmission among Ebola survivors, reinforce the importance of finding a robust and durable vaccine for this disease.
The Phase 1 study was performed in Oxford, UK, and enrolled healthy participants aged 18 to 50 years. Of 75 active vaccine recipients, 64 attended follow-up at day 360, the latest time point analyzed. No vaccine-associated serious adverse events were observed from day 240 to day 360. All of the active vaccine recipients maintained Ebola virus-specific antibody (immunoglobulin G) responses from the first post-vaccination analysis conducted through to day 360. As reported by Dr Matthew Snape, Chief Investigator of the study, this is the longest duration follow-up for any heterologous prime-boost Ebola vaccine regimen yet published.
A total of 10 clinical studies 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.
In September 2016, Janssen completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for the investigational preventive Ebola prime-boost vaccine regimen. EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of approved treatment or prevention options. If WHO grants an emergency use listing, this will accelerate the availability of Janssen’s investigational vaccine regimen to the international community in the event another Ebola crisis occurs.
Janssen in partnership with Bavarian Nordic rapidly scaled up production of the vaccine regimen and now has approximately 1,800,000 regimens available, with the capacity to produce several million regimens if needed.
About the Ebola Vaccine Regimen
The heterologous prime-boost Ebola vaccine regimen contains two components: Janssen’s AdVac® technology (based on adenovirus type 26) and MVA-BN® technology from Bavarian Nordic A/S (based on modified vaccinia virus Ankara). These vaccines both use a viral vector approach, where a benign virus is modified to safely express key proteins of the target virus, in this case Ebola virus. Prime-boost vaccination is an established approach for the prevention of several infectious diseases.
Janssen’s investigational Ebola vaccine regimen was developed in a collaborative research program with the National Institutes of Health (NIH) and 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.
The results of the Phase 1 data published in JAMA are generated under Europe’s Innovative Medicines Initiative (IMI) grant agreement EBOVAC1 (grant nr. 115854). Janssen’s partners in EBOVAC1 are the leading global research institutions the London School of Hygiene & Tropical Medicine, the University of Oxford, and Inserm, the French National Institute of Health and Medical Research. The IMI2 Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Additionally, the NIHR Oxford Biomedical Research Centre provides support to the Oxford Vaccines Group, which conducted the Phase 1 study.
This vaccine program also receives funding up to $28.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, under contract HHSO100201500008C.
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 126,400 employees at more than 230 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 the Janssen Pharmaceutical Companies
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 www.janssen.com. Follow us at @JanssenGlobal.
Cautions Concerning Forward Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development and production capacity of an Ebola vaccine regimen. 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 research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; the uncertainty of commercial success, including uncertainty regarding the level of demand for a vaccine against Ebola; manufacturing difficulties and delays, including the challenges and risks involved in large-scale production of a vaccine; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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 January 1, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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