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GSK launches Ebola Phase III trial in Liberia

Published on 23/01/15 at 11:58am
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A shipment of GSK’s potential vaccine against the Ebola virus disease is on its way to Liberia ready to be used in the first-ever large-scale Phase III clinical trial.

The British company says the study is due to start ‘very shortly’ – expected to be in the next few weeks, subject to regulatory approval. GSK is working with the US National Institutes of Health, the World Health Organization and the Wellcome Trust to develop the candidate vaccine.

The cargo of 300 vials is being sent to Liberia – the country most heavily affected by Ebola, which has seen an estimated 3,600 deaths since the outbreak began. The vaccine will be tested in healthcare workers, and researchers hope to enrol up to 30,000 people in the trial, a third of whom would get GSK's medicine.

The treatment is also currently being tested in five small Phase I clinical trials in the UK, US, Switzerland and Mali, involving around 200 healthy volunteers. GSK says that the initial data from these trials show that the candidate vaccine is safe.

The late-stage study will compare the candidate vaccine to a control vaccine, to assess whether the immune response seen so far in the Phase I trials actually gives people meaningful protection against Ebola.

This week the World Health Organization said that the Ebola outbreak in West Africa appears to be waning, prompting some experts to question whether a vaccine will be available in time to have the most impact.

But WHO cautioned against complacency, as preventive medicines may still be needed for future outbreaks. This epidemic has seen 21,724 cases reported in nine countries since it started in Guinea a year ago, and 8,641 people have died, according to WHO figures.

Dr Moncef Slaoui, chairman of global vaccines at GSK, says: “Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine. The initial Phase I data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing.

“If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks.”

GSK to make ‘reputational gains’

Speaking at a debate held by the All Party Parliamentary Groups on Africa and Global Health at Westminster this week, Jon Pender, vice president of government affairs at GSK, said the right incentives are key for the pharma companies - including Johnson & Johnson’s partnership with Bavarian Nordic, and Merck, who are collaborating with NewLink Genetics.

“Governments can and have been incentivising by sharing costs and risks through public-private partnerships. It’s not all about financial incentives – after all, a $200-300,000 incentive is attractive for a small start-up but not for a multinational. We maybe more incentivised by reputational gains.

“Market-based incentives are probably counter-productive. We’re not looking to make money but we’re not looking to lose money either. These are diseases of poverty and we’re not going to make money so sharing the cost of development is really important.”

Lilian Anekwe

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