GSK to manufacture 10,000 Ebola vaccine doses as trials are fast-tracked
The Phase I trials will assess the safety of an experimental vaccine that is based on two formulations, with full results expected in 2015.
Source: Eyepress / SIPA / Rex Features
GlaxoSmithKline (GSK) plans to manufacture around 10,000 additional doses of its experimental Ebola vaccine as Phase I clinical trials in healthy volunteers are expected to start in the UK, The Gambia, Mali and the United States from September 2014.
The news comes as the World Health Organisation (WHO) issued a roadmap on 28 August 2014 to scale up the international response to the disease, which has killed more than 1,500 people in West Africa so far in this outbreak.
The vaccine, which is being co-developed with the US National Institutes of Health (NIH), is based on an attenuated strain of chimpanzee cold virus, called chimp adenovirus type 3 (ChAd3). The adenovirus is used as a carrier, or vector, to deliver benign genetic material derived from the Ebola virus.
A total of 160 volunteers will be given a single dose of the vaccine: 60 people in the UK, 40 in Mali, 40 in The Gambia and 20 in the US.
Two formulations of the vaccine will be used, however. In the UK, The Gambia and Mali, volunteers will receive a monovalent version of the vaccine containing the Zaire species of Ebola, which is circulating in West Africa. In the US, volunteers will receive a bivalent vaccine, containing the Zaire and Sudan strains of the Ebola virus.
The US trial is expected to start in early September 2014, while the other trials are expected to follow a few weeks later. Initial results from the trial are expected at the end of 2014 and full results in mid-2015, says a GSK spokesperson.
It is not clear whether the vaccine will go through the European Medicines Agency (EMA) for regulatory approval as was seen recently with GSK’s malaria vaccine, which is also mostly needed in developing countries.
“It is probably too early for us to be able to comment on how we might file the vaccine candidate with regulators if it were successful,” says the GSK spokesperson. “In addition, because of the highly lethal nature of this viral disease, we expect that late-stage clinical development will require new regulatory pathways that are as yet untried for a prophylactic vaccine. We are working closely with regulators to understand and map out a way forward.”
In terms of its pricing, the spokesperson said that as Ebola affects the poorest countries, GSK is thinking of forming partnerships to make it available to people who need it.
Umberto D’Alessandro, director of the Medical Research Council (MRC) Unit in The Gambia is hopeful that the vaccine will soon be available.
“The proposed trial won’t benefit immediately those currently at risk but we hope that in a not too distant future we may be able to protect people against Ebola,” he said.
A £2.8 million grant from the medical charity the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Department (DFID) is contributing to the funding of the trial.
GSK says the funding will enable it to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful, stocks could be made available immediately. The WHO could then create an emergency immunisation programme for high-risk communities.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066299
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