Researchers see risk of mutant airborne Ebola as remote

The first British volunteer of a new Ebola vaccine made by GlaxoSmithKline has been injected in a fast-tracked safety trial.

Ruth Atkins, a communications and engagement manager working for NHS Central Southern Commissioning Support Unit from Marcham in Oxfordshire who is 48 years of age, was injected with the candidate Ebola vaccine in her upper arm this morning, after a clinical assessment and a blood sample was taken. She is the first of 60 volunteers to participate in the Oxford trial, which is being led by Professor Adrian Hill of the University’s Jenner Institute.

Ms Atkins, who has previously worked as a nurse in the NHS, said: ‘I volunteered because the situation in West Africa is so tragic and I thought being part of this vaccination process was something small I could do to hopefully make a huge impact. I first heard about the trial while driving home from work when Professor Hill was interviewed on BBC Radio Oxford and asked for volunteers to come forward.

‘I did not realise until today how many people behind the scenes have worked extra and unsociable hours to get this to trial so quickly. The team has been so helpful and supportive, coming in for early morning appointments to allow me to take part before I go to work.’

Speaking an hour after the vaccination, she said: ‘I feel absolutely fine, it felt no different to being vaccinated before going on holiday.’

The candidate Ebola vaccine has been co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline against the Zaire species of Ebola, which is the one circulating in West Africa.

It uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola.

The UK trial beginning today is part of a series of safety trials of potential Ebola vaccines aimed at preventing the disease. These have been fast-tracked in response to the current outbreak in West Africa, which has killed more than 2,250 people.

The UK trial is being led by Professor Adrian Hill of the Jenner Institute at the University of Oxford, and will run alongside similar trials in the USA carried out by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).

Professor Adrian Hill, Director of the Jenner Institute at the University of Oxford, said: ‘Witnessing the events in Africa makes it clear that developing new drugs and vaccines against Ebola should now be an urgent priority. It is tremendous that so many people have worked hard to make this trial happen in short time, and I am enormously grateful to those volunteers who have come forward to take part and to the funders including the Wellcome Trust, DFID, MRC and MHRA for supporting this trial so quickly.

‘These are initial safety trials of the vaccine and it will be some time before we know whether the vaccine could protect people against Ebola. But we are optimistic that the candidate vaccine may prove useful against the disease in the future.’

The safety trials with small groups of healthy volunteers are required to ensure that the vaccine does not cause unforeseen side effects, and that it generates a good immune response to Ebola in humans. This is necessary before the vaccine can be rolled out to larger at-risk populations, even on an experimental basis.

Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that the vaccine provides promising protection in non-human primates exposed to Ebola without significant adverse effects.

The UK trial is being funded under a £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID).

The consortium’s funding also enables GSK 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 then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.

The NIH is providing the NIAID/GSK Ebola vaccine for the Oxford study.

NIAID are testing this same vaccine in the USA, in addition to a related vaccine that is designed to protect against two Ebola species (Ebola Zaire and Ebola Sudan).

This collaborative multi-trial approach will help ensure the fastest possible progress to determining the best candidate vaccine approach and delivery.

It is hoped that the phase 1 trials might be finished by the end of 2014, after which deployment of the vaccine could be fast-tracked should it prove to be safe and immunogenic.

Dr Moncef Slaoui, Chairman of Global R&D and Vaccines at GSK, said: ‘The promising results of the preclinical studies of this Ebola vaccine candidate give us confidence to now move forwards with further testing. While it is still early days we are committed to working with our partners to accelerate development of the vaccine and explore how it could contribute to the control of Ebola outbreaks.’

Dr Ian Hudson, the Medicines and Healthcare Products Regulatory Agency’s chief executive, said: ‘Our priority is to protect public health. Given the importance of Ebola as a risk to public health in some countries in Africa, we fast-tracked the review of the clinical trial application for this vaccine so that it was assessed and authorised by the MHRA’s experts in just four working days.

‘This was achieved through close liaison and coordination with the researchers in the Oxford team and our experts to ensure that the time, including the weekend, could be fully utilised to rapidly address a small number of clarifications and modifications required following the initial assessment of the clinical trial application.’

International Development Secretary, Justine Greening said: ‘The UK has been on the front foot from the outset to help West Africa combat the world’s worst Ebola outbreak. We have provided £25.5 million to agencies providing critical care, deployed scientists to better understand the disease and we are building a treatment centre in Sierra Leone.

‘Britain is a world leader in medical research and our co-funding of clinical trials is ensuring this research begins quickly so it might help as many people as possible.’

Professor Dame Sally Davies, Chief Medical Officer said: ‘I am delighted to see the UK health research system working together so quickly and effectively for the benefit of patients. This will be a pivotal next step in helping the world fight against the Ebola virus.’

Agencies/Canadajournal