Promising Ebola vaccine regime to be fast-tracked

Johnson & Johnson is to fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak.

The accelerated vaccine programme features a prime-boost regimen, in which one vector is used to prime and the other to boost the immune response. It consists of two vaccine components that are based on AdVac technology from Crucell and the MVA-BN technology from Bavarian Nordic. The programme has received direct funding and is also utilising vaccine preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health (NIH).

Crucell will bring this development programme forward, in close collaboration with Bavarian Nordic and the NIAID, to allow for initiation of a clinical trial of this combined regimen in humans in early 2015.

Johnson & Johnson's multi-pronged approach, as part of its overall commitment to prevent disease in vulnerable populations, includes: an intensive review of known pathways in Ebola pathophysiology to determine whether previously tested medicines can be used to help patients survive an Ebola infection; and additional support to the non-profit organisation Direct Relief International to facilitate the air transport of a variety of infection prevention products to Liberia and Sierra Leone.

Crucell and Bavarian Nordic are both currently developing preventative vaccines against filoviruses, including Ebola virus, with direct funding and vaccine preclinical services from NIAID. In addition, the two companies have developed a combination regimen that harnesses the potency of both vaccines and could be used to elicit protective immunity against the Zaïre species of the Ebola virus, which is responsible for the current outbreak in West Africa. The combination vaccine provided complete protection of vaccinated macaques against disease and death after exposure to a highly virulent wildtype Ebola Zaire strain.

The combination regimen uses proven vaccine technology platforms from both companies that have shown to be immunogenic and safe when used in humans for other applications: to date more than 1,000 humans have received Crucell's adeno-platform based vaccine in clinical trials, while Bavarian Nordic's MVA-BN platform is the basis of the smallpox vaccine registered in Canada and Europe and stockpiled in the rest of the world with a safety record of use in more than 7,300 humans. In addition to the clinical advantage of the combination regimen, the collaboration also allows for faster production with each company taking on the production of one element of the combination regimen.

Crucell has been exploring vaccines in partnership with the NIH since 2002. This new research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development programme for a multivalent vaccine against all filoviruses that cause disease in humans, including Ebola and Marburg viruses.

'In light of the current emergency in West Africa and given the evident, huge unmet medical need, we are stepping up our efforts and accelerating the Ebola programme currently in pre-clinical development,' said Johan Van Hoof, Global Head, Infectious Diseases and Vaccines, Janssen and Managing Director, Crucell. 'We recognise the urgency of the situation and the need to collaborate with multiple partners to develop treatment and preventive solutions for Ebola.'

'Our primary goal in this escalating Ebola epidemic is to assist governments in protecting healthcare workers, families and populations who are at high risk of being infected with Ebola as soon as possible in an effort to stop the disease from spreading further,' said Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.

'With a strong heritage in collaborative partnerships and a proven track record in the rapid development and access of innovative products, we aim to ultimately eradicate deadly diseases like Ebola and save lives around the world.'