Johnson & Johnson reports 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.

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 US 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, 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.

In January 2015, Europe's Innovative Medicines Initiative (IMI) awarded a consortia of global research institutions and non-government organizations working in conjunction with the Janssen Pharmaceutical Companies grants totaling more than EUR 100 million from the Ebola+ program to support the development, manufacturing, and deployment of the vaccine regimen.

Janssen's 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, 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 program and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

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), 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 US Department of Health and Human Services, to help accelerate the development of the prime-boost vaccine regimen.

Source: Johnson & Johnson