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.
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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.