GSK Ebola vaccine ‘promising’ in early trials
The first trial results for GlaxoSmithKline’s (GSK) Ebola vaccine candidate have shown that the medicine was well-tolerated and produced an immunological response in the participants.
The small Phase I study, conducted by the US National Institute of Health (NIH), only tested the vaccine on 20 healthy adults in America, but further trials in other countries are underway – including a trial in Mali assessing its safety and immune response in West African populations.
“It’s important to remember that these data are the first piece in the jigsaw and we’re continuing to gather other important information,” says Dr Moncef Slaoui, chairman of global vaccines at GSK.
“We are very encouraged by these positive first trial results showing this type of vaccine has an acceptable safety profile and can produce an immune response against Ebola in humans.”
The vaccine was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotech company acquired by GSK in 2013. It uses a type of chimpanzee cold virus to deliver genetic material from two strains of Ebola – the Sudan strain and the Zaire strain, which is responsible for the current Ebola outbreak in West Africa.
GSK has been accelerating development on two versions of the vaccine – one which targets both strains, and one that only targets the Zaire strain in response to the current epidemic.
The UK firm says that data from ongoing Phase I trials in the US, UK, Mali and Switzerland is expected by the end of the year. Should they prove successful, the next phase will begin in early 2015 and will involve the vaccination of thousands of frontline healthcare workers in Sierra Leone and Liberia – two of the affected countries.
“If the candidate vaccine is able to protect these healthcare workers as we hope it will, it could significantly contribute to efforts to bring this epidemic under control,” Slaoui says.
Further safety studies will also be conducted in West African countries not affected by the current outbreak in adults and children.
In a statement the company adds: “GSK continues to work with the World Health Organization (WHO), regulators and other stakeholders to determine possible solutions to accelerate the development of the Ebola candidate vaccine with the goal of trying to limit the further spread of the epidemic.
“Its potential future use in mass vaccination campaigns will depend on whether they are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects, and how quickly large quantities of vaccine can be made.”
GSK says it is also looking at whether use of a booster vaccine may help provide longer-lasting protection.
GSK has previously cautioned that its Ebola vaccine will come ‘too late’ for the current outbreak, despite being fast-tracked. Dr Ripley Ballou, the head of the company’s Ebola vaccine research, told the BBC last month that it will be ‘well into 2016’ before they will be able to manufacture the required about.
Other companies are developing vaccines, however. Johnson and Johnson also recently announced the fast-tracking of its own candidate, and Takeda has told Pharmafile that they are looking at its pipeline ‘very carefully’ and identifying potential candidates.
WHO is also allowing untested Ebola treatments to be used on patients in West Africa, with mixed results so far.
The current Ebola outbreak has been ravaging the West African countries of Liberia, Guinea and Sierra Leone and has now killed over 5,500 people. A few other cases have been reported in other African countries, as well as in Europe and the US, although these areas are now mostly Ebola-free.
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