Clinical trials of an experimental vaccine developed by a research team at Oxford University to protect patients against Ebola are progressing rapidly.
In just over two months, almost 200 people have been given the potential vaccine, in safety trials performed in the UK, the USA, Mali and Switzerland. The first volunteer to receive the vaccine in this trial was Ruth Atkins of Oxfordshire, on the 17th September 2014.
Since Ms Atkins, there have been 20 people at the US National Institutes of Health in Bethesda, Maryland, 80 people at the University of Maryland School of Medicine Centre for Vaccine Development in Mali (a joint venture with the Ministry of Health of Mali), and 34 people at the University Hospital of Lausanne. It is hoped that by December, the number of trialists at the University Hospital of Lausanne will have reached 120.
On Tuesday 18th November, the 60th and last healthy volunteer in a trial carried out by the University of Oxford received the vaccine.
The vaccine is being developed by the transnational pharmaceutical company GlaxoSmithKline (GSK), in partnership with the US National Institutes of Health. The Chief Investigator of the vaccine development is Professor Adrian Hill, at the Jenner Institute at Oxford University.
The aim of the vaccine is to protect people who don’t have Ebola from becoming infected, and is thus a preventative measure to ward against the disease. The vaccine is targeted at the Zaire Ebola Virus species, the strain currently prevalent in West African countries.
If the safety and immunogenicity data from the Phase 1 trials are promising, the vaccine is expected to move into the next phases of study to further evaluate safety as well as effectiveness in protecting against Ebola infection in African countries.
Professor Adrian Hill of the Jenner Institute at Oxford University was pleased with the progress of the vaccine. He told Cherwell, “The safety data here have looked very satisfactory so far. The response we have seen from people coming forward to take part has been remarkable.” No significant adverse effects have been identified in non-human primates in response to the vaccine.
The vaccine itself does not contain any infectious Ebola virus material, so cannot cause a person who has the inoculation to become infected with Ebola. The vaccine uses a single gene from the Ebola Virus to generate an immune response; this gene was initially extracted from a strain of the adenovirus present in chimpanzees.
The clinical trial in Mali, performed by the Centre for Vaccine Development of Mali (CVD-Mali), the CVD of the University of Maryland School of Medicine, and the Malian Ministry of Health, is providing the only clinical and immune response data to date of the vaccine in West African subjects.
The team are comparing this data to the immune responses observed in adults given the vaccine in the UK and Switzerland.
Professor Myron M Levine, director of the Centre for Vaccine Development, said, “This research is a testament to the hard work and cooperation of all the institutions involved. If this vaccine is proven to work, it could help alter the dynamic of this epidemic by interrupting transmission to the health care workers who are most at risk.”
The Oxford trial is being funded by a £2.8 million grant from the Wellcome Trust, the Medical Research Council and the UK Department for International Development. The consortium’s funding is also enabling GSK to begin manufacturing thousands of additional doses of the vaccine so that if Phase 1 trials are successful, the next phases of the clinical trial programme can begin – which will involve the vaccination of frontline healthcare workers in Ebola affected countries.
In addition to the development of the vaccine, a second research group at the University of Oxford are trialling a potential drug against Ebola. This treatment will be trialled next month by the humanitarian group Doctors Without Borders on Ebola sufferers in West African countries undergoing the Ebola epidemic.
The aim of this treatment is to reduce death rates amongst patients who already have the disease, thus boosting survival. The Chief Investigator of this trial is Professor Peter Horby of the Centre for Tropical Medicine and Global Health at Oxford University.
The drug is called brincindofovir and is manufactured by a biotech company called Chimerix in the USA, who developed the drug.
Professor Horby stressed the huge importance of developing resistance to Ebola, with both vaccinations and drugs, commenting, “The Ebola epidemic remains a major public health crisis of unprecedented scale, and urgent action is needed to contain this dreadful menace.”
“Actions are needed on multiple fronts, including early case detection and isolation and treatment, safe and dignified burials, social mobilisation, but also trials of new vaccines and drugs.”
“Conducting clinical trials in the midst of this crisis is extremely challenging, and we are having to develop new ways of working. But there is an imperative to move fast, and there is an enormous effort ongoing to fast-track the evaluation of drugs and vaccines.”
