GSK Ships Ebola Vaccine Candidate to Africa

By Pharma News - DCAT Publisher

January 23, 2015

GlaxoSmithKline (GSK) has announced that the first batch of its candidate Ebola vaccine is being shipped to west Africa and is expected to arrive in Liberia on January 23, 2015. The shipment, containing an initial 300 vials of the candidate vaccine, is the first to arrive in one of the main Ebola-affected countries and will be used to start the first large-scale efficacy trial of experimental Ebola vaccines in the coming weeks.

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 I studies were published in November 2014, and results from the remaining Phase I 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), 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 I trials actually translates into meaningful protection against Ebola. This trial will begin in Liberia in the coming weeks, subject to regulatory approval, with further shipments of vaccines to follow.

GSK is working with the World Health Organization and the Centers for Disease Control and Prevention in the US to assist with the design and to potentially support trials in other affected countries, Sierra Leone and Guinea, in the coming months. In parallel, GSK plans to begin large Phase II safety trials in non-affected west African countries.

The candidate Ebola vaccine that was shipped to Liberia was co-developed by the NIH's National Institute of Allergy and Infectious Diseases and Okairos, a biotechnology company acquired by GSK in 2013. It uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to deliver benign genetic material from the Zaire strain of the Ebola virus, which is responsible for the current Ebola outbreak in west Africa. GSK has been working with the NIH to accelerate development in response to the current Ebola epidemic.

Source: GlaxoSmithKline