Académie royale de Médecine de Belgique

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Philippe Denoel (GSK) - Résumé

GSK Ebola Vaccine Development

With >9,000 deaths due to the Ebola virus since March 2014, the president of the World Bank, Jim Kim, warned that the crisis is set to worsen and the global community was still not “moving fast enough”.  
GSK is working with the WHO and other stakeholders to accelerate the development of the NIAID/GSK Ebola vaccine candidate to determine that it is safe and effective for use in affected countries.
The candidate vaccine is currently being tested in five small phase I clinical trials in the UK, USA, Switzerland and Mali, involving around 200 healthy volunteers in total. Initial data from these trials show that the candidate vaccine has an acceptable safety profile, including in a West African population, and across the different doses evaluated. Based on the safety and immunological data available from these trials, GSK has selected the most appropriate dosage level to advance to the next phases of clinical testing. Results from the first of the phase 1 studies were published in November 2014 and results from the remaining phase 1 studies will be published in the coming months.
The selected dose will now be tested in a large phase III clinical trial led by the US National Institutes of Health (NIH) in Liberia which is expected to involve up to 30,000 people, one third of whom will receive GSK’s candidate Ebola vaccine. It will compare the candidate vaccine to a control vaccine to assess whether the immune response seen in phase 1 trials actually translates into meaningful protection against Ebola.
The need to rapidly scale up the candidate vaccine production process is therefore urgent. International-level commitments have been made by GSK to do everything we can to address production capacity while continuing progress towards a licensed vaccine. Ebola is a public health crisis for the world and GSK is playing a critical role in the response to this crisis.