Johnson & Johnson said that it will speed development of a new combination Ebola vaccine, with a clinical trial planned for early 2015. "The decision to accelerate the programme is based on the fact that it is such a catastrophic situation in West Africa," remarked chief scientific officer Paul Stoffels.
The prime-boost regimen consists of two vaccine components that are based on AdVac technology from Johnson & Johnson's Crucell unit and MVA-BN technology from Bavarian Nordic. The company noted that the combination vaccine provided complete protection of vaccinated macaques against disease and death after exposure to a highly virulent wildtype Ebola Zaire strain. According to Johnson & Johnson, more than 1000 humans have received Crucell's adeno-platform based vaccine in clinical trials, while Bavarian Nordic's MVA-BN platform has a safety record of use in more than 7300 people.
Clinical trials of the combination regimen, which is being developed with the US National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID), were previously expected to start in late 2015 or early 2016. The Phase I studies will include healthy volunteers to evaluate the vaccine's safety, as well as whether it can elicit a protective immune response. Stoffels noted that it had not yet been decided where the trials would be conducted or how many subjects would be recruited. He added that the company is also starting to work on producing the regimen on a larger scale for clinical testing and is exploring how to increase production for large-scale distribution for human use.
In the longer-term, Johnson & Johnson aims to develop a vaccine that can protect against both the Zaire and Sudan strains of Ebola, as well as Marburg disease. However, Stoffels said that "because of the emergency we decided to focus on the Ebola Zaire strain, which is the one in the West Africa outbreak, and that's why we can accelerate the programme significantly." The drugmaker also plans to conduct a review of known pathways in Ebola pathophysiology to determine whether previously tested medicines can be used to help patients infected with the virus.
Last month, GlaxoSmithKline said that it would expedite Phase I studies of its experimental Ebola vaccine having received funding from an international consortium, including the Wellcome Trust, the Medical Research Council and the UK Department for International Development. Studies of the vaccine, which GlaxoSmithKline is co-developing with the NIH, will also be conducted in the US by the NIAID.