J&J, partners speed pace of Ebola prime-boost vaccine
This article was originally published in Scrip
Johnson & Johnson and its partners are the latest to quicken the pace of a product against the Ebola virus, in this case, accelerating the development program for a prime-boost vaccine regimen, which is being funded in part by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
J&J and its subsidiary Crucell and the NIAID previously said the vaccine, which uses recombinant adenovirus vector platforms, would be entering clinical testing in late 2015 or early 2016.
But in response to the Ebola crisis in West Africa – an epidemic in which nearly 2,000 people have died – J&J revealed on 4 September the timeline for a clinical trial of the combination vaccine regimen had been moved up to early 2015 under the company's collaboration with NIAID and Bavarian Nordic (scripintelligence.com, 4 September 2014).
"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 pre-clinical development,” said Dr Johan Van Hoof, global head of infectious diseases and vaccines at J&J's Janssen unit and managing director at Crucell.
The news of the J&J/Bavarian Nordic vaccine follows the revelation late last week the FDA had expedited its review of the protocols for a Phase I trial of an Ebola vaccine co-developed by the NIAID and GlaxoSmithKline, allowing a study to get underway this week at the NIH (scripintelligence.com, 28 August 2014).
The NIH study is the first of several Phase I trials launching in the coming weeks aimed at examining the investigational NIAID/GSK Ebola vaccine and an experimental shot developed by the Public Health Agency of Canada and licensed to NewLink Genetics.
The NIH is collaborating with the Department of Defense in support of efforts by NewLink Genetics to conduct Phase I safety studies of VSV-EBOV, an investigational recombinant vesicular stomatitis virus Ebola vaccine.
Those clinical trials are expected to begin sometime in the fall at the Clinical Trials Center of the Walter Reed Army Institute of Research in Silver Spring, Maryland.
The US Biomedical Advanced Research and Development Authority earlier this week put up $24.9m to help expedite development of Mapp Biopharmaceutical's experimental Ebola drug ZMapp, which has been used outside of clinical testing in at least seven people (scripintelligence.com, 3 September 2014).
The NIAID also provided more cash to BioCryst to help its product move quicker through the R&D process (scripintelligence.com, 1 September 2014).
J&J said its vaccine consists of two components, which are based on Crucell's AdVac technology and Bavarian Nordic's MVA-BN technology.
Crucell and Bavarian Nordic each currently are developing vaccines against filoviruses, such as Ebola, with direct funding and vaccine preclinical services from the NIAID.
J&J said more than 1,000 people 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 companies' prime-boost combination vaccine harnesses the potency of both products and could be used to elicit protective immunity against the Ebola Zaire species – the strain currently spreading through West Africa, J&J insisted.
Indeed, the vaccine combo provided complete protection of vaccinated Rhesus macaques against disease and death after exposure to a highly virulent wild-type Ebola Zaire strain – results that are driving the speeded up timeline for the human testing to begin earlier than originally anticipated.
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, J&J said.