6 January 2015
Oxford University doctors and scientists are starting the first safety trial of an experimental preventative Ebola vaccine regimen being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen).
The Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics, aims to have vaccinated all 72 healthy adult volunteers by the end of January.
The development of this prime-boost vaccine regimen has been accelerated in response to the current outbreak of Ebola virus disease in West Africa, which has claimed over 6,000 lives. An effective vaccine would be an important step in controlling the spread of disease.
Volunteers for the trial, aged 18–50 years, are likely to come largely from the Oxfordshire region, and will be asked to make a maximum of 12 visits to the Oxford Vaccine Group site on the city’s Churchill hospital site over a period of a year.
The study involves a prime-boost vaccine regimen, in which patients are first given a prime to the immune system to stimulate an initial immune response, and then a boost intended to further enhance the level of the body’s immune response over time.
The vaccine regimen does not contain any replicating virus, so it is not possible to be infected with Ebola.
Pre-clinical studies have demonstrated that the prime-boost regimen, given two months apart, provides non-human primates with complete protection from death due to the Kikwit Zaire strain of Ebola – which is similar to the virus causing the current outbreak in Western Africa.
People interested in volunteering can find out more at www.ebolavaccine.org.uk.
‘We aim to immunise all participants within a month,’ says Dr Matthew Snape of the Oxford Vaccine Group, who will lead the study team. ‘The main aim is to understand the safety profile of the vaccines.’
He adds: ‘The devastating Ebola epidemic in Guinea, Liberia and Sierra Leone continues to see hundreds of new cases each week and has placed huge burden on these countries’ infrastructures. While public health measures are currently still the best way to bring the outbreak under control, if we have a safe and effective vaccine it could begin to have an impact later this year. That is the goal that is seeing manufacturers, public health bodies and research regulators come together to accelerate the first clinical trials of new Ebola vaccines.’
The trial is being sponsored by Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, which has chosen the Oxford Vaccine Group to carry out the study. Ongoing support from the NIHR Oxford Biomedical Research Centre has also made such a rapid response possible through funding for core research staff at the Oxford Vaccine Group.
This is the second safety trial of an Ebola vaccine to be carried out at the University of Oxford. In September, a separate Oxford University team in the Jenner Institute began a safety trial of a different Ebola vaccine developed by GSK/US National Institutes of Health (NIH). Led by Professor Adrian Hill, the trial vaccinated 60 healthy volunteers and initial results are expected this month.
Those who couldn’t take part in the earlier Jenner Institute trial because recruitment was complete can be considered for this new Oxford Vaccine Group trial of an Ebola vaccine.
The primary objective of the Oxford Vaccine Group study is to determine the vaccine regimen’s safety profile. It will also test in which order the two vaccine components should be given in a prime-boost regime, and how far apart.
The immune responses that the vaccine generates – both antibodies and T cells – will also be measured over a period of one year. Further studies of the vaccine regimen are being planned for the United States and in Africa early next year.
As well as the Janssen and GSK/NIH Ebola vaccines, Merck & Co has recently bought the rights to a third Ebola vaccine being developed by the biotech company NewLink Genetics. Other vaccines are also in development in Russia.
Dr Snape says: ‘The fact that there are at least three Ebola vaccines entering these early safety trials is good news. We are not playing first past the post here. Having multiple vaccines progressing through clinical trials increases the likelihood of vaccine manufacturers having the capacity to meet production demands should mass immunisation be required. The more vaccines and more manufacturers there are working on this, the better.’
For more information please contact Dr Matthew Snape on email@example.com
Or the University of Oxford news & information office on +44 (0)1865 280530 or firstname.lastname@example.org
Notes to editors:
- Johnson & Johnson are also issuing a press release today.
- In September, Johnson & Johnson announced it would fast-track the development of Janssen’s combination vaccine regimen against Ebola in response to the current outbreak: http://www.jnj.com/news/all/Johnson-Johnson-Responds-to-Ebola-Crisis-with-Commitment-to-Accelerate-Vaccine-Program-in-Collaboration-with-the-US-National-Institutes-of-Health-NIH-and-Provide-Humanitarian-Relief-Aid
- Johnson & Johnson then announced on 22 Oct that it was making a commitment of up to $200 million to accelerate and expand the production of an Ebola vaccine in development at its Janssen Pharmaceutical Companies: http://www.jnj.com/news/all/Johnson-Johnson-Announces-Major-Commitment-to-Speed-Ebola-Vaccine-Development-and-Significantly-Expand-Production
- In the 22 Oct release, Johnson & Johnson stated that Janssen was planning to test the safety and immunogenicity of the vaccine in healthy volunteers, starting in early January. The Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics, has now been selected to carry out such a study in the UK.
- It is hoped that 72 volunteers in Oxford will have received the first vaccination by the end of January, with the second vaccination happening 1 or 2 months later depending on which arm of the trial people are allocated to.
- Janssen is targeting production of more than one million doses of the vaccine regimen in 2015, 250,000 of which are expected to be released for broad application in further clinical trials by May 2015. * The ‘prime’ and ‘boost’ vaccines have different components. One component makes use of technology from Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. A non-replicating human adenovirus is used as a base for the vaccine, to which genes for a protein from the Zaire strain of the Ebola virus is added The other vaccine, made by the company Bavarian Nordic in Denmark, is based on a non-replicating modified vaccinia Ankara (MVA) virus, to which genes for the protein from the Zaire strain of Ebola virus is added, along with genes coding for proteins from the related viruses Marburg, Sudan virus, and Taï Forest virus. Neither the adenovirus nor the MVA virus in the vaccines can cause disease, nor can anyone be infected with Ebola or the other related diseases from the vaccines.
- The design of the Oxford University trial will see the 72 volunteers allocated into four groups of 18 people. 15 people in each group will receive the vaccine, and 3 a placebo. The first group will receive the MVA vaccine as a ‘prime’ and the adenovirus vaccine as a ‘boost’ one month later. The third group will receive the vaccines in the opposite order; first adenovirus and second MVA. Groups 2 and 4 will mirror groups 1 and 3, but receive the vaccines two months apart.
- The Oxford Vaccine Group, part of the University of Oxford, is headed by Professor Andrew Pollard and conducts studies of vaccines in both adults and children. Over the last nine years the group has recruited over 7000 participants to clinical trials of vaccines. In addition to studying vaccines against meningitis and respiratory infections the Oxford Vaccine Group is currently conducting world-leading research on the vaccine prevention of typhoid and paratyphoid disease.
- Oxford University’s Medical Sciences Division is one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK’s top-ranked medical school.
From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery.
A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions.
- The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).