Johnson & Johnson has committed to accelerate its Ebola vaccine program in collaboration with the NIH. J&J will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate to deliver immediate relief aid to address the current Ebola outbreak.

The accelerated vaccine program 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, part of the Janssen pharmaceutical companies of J&J, based in the Netherlands, and the MVA-BN technology from Bavarian Nordic, a biotech company based in Denmark.

The program has received direct funding and also is utilizing vaccine preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. Crucell will bring this development program 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.

The company's expedited vaccine development schedule is in response to the current Ebola outbreak in West Africa and is aligned with the World Health Organization's (WHO) Ebola Response Roadmap, including its call to fast-track access to treatment and vaccine options to address the Ebola virus outbreak.

J&J'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 nonprofit organization Direct Relief International to facilitate the air transport of a variety of infection prevention products to Liberia and Sierra Leone.

“Our primary goal in this escalating Ebola epidemic is to assist governments in protecting health care 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, M.D., chief scientific officer of J&J.

Crucell and Bavarian Nordic are both currently developing preventive 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.

Based on these promising results, Bavarian Nordic, Crucell and NIAID intend to advance this development program to allow for initiation of a human trial in early 2015.

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.

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 as well as other related programs targeting diseases with potential widespread social impact 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 program 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 program currently in preclinical development," said Johan Van Hoof, M.D., global head, infectious diseases and vaccines, Janssen and managing director, Crucell. "We recognize the urgency of the situation and the need to collaborate with multiple partners to develop treatment and preventive solutions for Ebola."

The emergence of Ebola in West Africa also has strained the health care systems of Liberia, Sierra Leone and Guinea. Johnson & Johnson also is participating in the ongoing efforts by public health authorities, including the Centers for Disease Control and WHO, to mount a coordinated world response to address the immediate needs raised by the Ebola outbreaks.