Oxford University starts trial of new Ebola vaccine7 January 2015 Oxford University has started a clinical trial of an experimental preventative Ebola vaccine regimen. The Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics, aims to have vaccinated 72 healthy adult volunteers by the end of January. This is the second trial of an Ebola vaccine carried out in Oxford, following one carried out by a separate team last September. This vaccine is being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The trial is being sponsored by Crucell Holland B.V., one of the Janssen Pharmaceutical Companies. The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), uses a prime-boost combination of two components that are based on AdVac technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN technology from Bavarian Nordic, a biotechnology company based in Denmark. In October 2014, Johnson & Johnson announced a commitment of up to $200 million to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company says it is seeking to share the financial risk of these vaccine and development clinical trial costs by pursuing governmental and non-governmental funding sources. The primary objective of the study is to determine the vaccine regimen's safety profile. 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. It will also test in which order the two vaccine components should be given in a prime-boost regime, and how far apart. The vaccine regimen does not contain any replicating virus, so it is not possible to be infected with Ebola. Pre-clinical studies conducted by the US National Institutes of Health 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. The immune responses that the vaccine generates — both antibodies and T cells — will also be measured over a period of one year. "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. 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.' Further studies of the vaccine regimen are being planned for the United States and in Africa — a trial in Liberia at the Médecins Sans Frontières (MSF) ELWA 3 Ebola Management Centre in Monrovia started on 2 January. Johnson & Johnson also announced on 6 January 2015 that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12 to 18-month period. This increased projection is an update to Janssen’s previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015. 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. As well as the Janssen and GSK/NIH Ebola vaccines, Merck & Co has recently bought the rights to a third Ebola vaccine, VSV-ZEBOV, being developed by the US biotech company NewLink Genetics and produced by German company IDT Biologika. This was first developed by Canadian scientists and the Canadian government still owns the intellectual property rights. Trials of the VSV-ZEBOV experimental vaccine have begun in the US, Canada, Switzerland, Germany and Gabon and trials are expected to begin soon in Kenya. Other vaccines are also in development in Russia. Dr Snape added, "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." Volunteering People interested in volunteering can find out more at www.ebolavaccine.org.uk 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. 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. |
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