Blood plasma from people who have survived Ebola may be one potential treatment for Ebola, as it may contain antibodies that likely helped survivors successfully fight off the disease. A study including Professor Peter Horby has now found that such treatment during an Ebola outbreak is feasible and safe.
Professor Peter Horby, who was recently awarded a UK Government Ebola Medal for Service in West Africa for his role in fighting the 2015 Ebola outbreak, talks about the history and science of Ebola. This public lecture was given as part of Oxford Open Doors, on the 12th September 2015. This talk describes the experience of conducting scientific research in the middle of an outbreak of one of the world’s most lethal diseases, and the challenges of ensuring sound clinical trials in countries with limited health resources.
Nuffield Department of medicine scientists received the Ebola medal for their part in beating the Ebola outbreak in West African in 2015. The researchers and clinicians received their medals from Sir Andrew Hamilton, the Vice Chancellor for the University of Oxford, and Professor Sir Peter Ratcliffe, who heads the Nuffield Department of Medicine.
Writing in the journal Nature, Professor Trudie Lang says in order to tackle the next Ebola outbrak, there must be agreement now on how to integrate research with the emergency medical response. She suggests pre-agreed plans for trials, addressing concerns such as data ownership and drug pricing in advance.
A clinical trial to evaluate an Ebola vaccine has begun in Dakar, Senegal, after initial research started at the Jenner Institute. A new accelerated vaccination approach is being tested in parallel in the UK and Senegal. If successful, it would provide an option to respond to an Ebola outbreak with a rapid vaccination programme.
Oxford University doctors and scientists are performing the second phase of clinical studies of an experimental Ebola vaccine regimen. The study is part of the EBOVAC2 project, a collaborative programme. Professors Andrew Pollard affiliated with the Jenner Institute is the Director of the Oxford Vaccine Group.
An Oxford University led study into the effectiveness of a potential Ebola treatment, called TKM-Ebola-Guinea, is no longer recruiting patients after reaching a pre-defined endpoint.
In an article in the official publication for the G7 meeting, Professor Peter Horby, who leads the Epidemic Research Group Oxford (ERGO), and Professor Adrian Hill, director of vaccine research centre the Jenner Institute, warn that it is vital to get ahead of the next outbreak.
In a letter published in the Wall Street Journal, Professor Peter Horby and other Ebola researchers respond to an earlier article on clinical trials for Ebola treatments. 'The scientific community must find ways to conduct essential trials and share their results swiftly, ethically and without controversy when inevitable outbreaks arise.', the letter concludes. A full list of signatories and the text of the letter is also available on the Wellcome Trust website.
Initial results from the Phase 1 trial for the rVSV ZEBOC candidate Ebola vaccine have now been published. The trial found that the candidate vaccine had no serious side effects although some volunteers experienced fever for the first few days after vaccination, and some developed transient pain and/or swelling of their joints. The candidate vaccine was able to raise antibody responses that neutralized Ebola-like virus particles in the laboratory.
The trial team in Kilifi was led by Dr. Patricia Njuguna with support from Prof Philip Bejon and Dr Benjamin Tsofa. Although there are no cases of Ebola reported in Kenya, demonstrating safety and immune responses by the vaccine in the Kenyan population will facilitate use of the vaccine if necessary.
Professor Adrian Hill will lead a clinical trial in to a new two-shot Ebola vaccine approach. The trial will look at the effect of vaccinating with the GlaxoSmithKline vaccine followed by a new kind of booster from Emergent BioSolutions. An initial Phase I clinical study in to the safety and efficacy of this two-shot approach will shortly be conducted by researchers at the University of Oxford.
As of 11th March 2015, a Phase II clinical trial of a potential Ebola treatment is underway in Sierra Leone. The trial of the therapy, TKM-Ebola-Guinea, is being led by Professor Peter Horby. TKM-Ebola-Guinea is a synthetic small interfering RNA therapeutic designed specifically to target the strain of the Ebola virus responsible for the present outbreak in Guinea, Liberia and Sierra Leone.
Professor Horby said: "There are still around 10 new cases of Ebola being diagnosed every day in Sierra Leone. It’s therefore essential that we push forward with clinical trials while we still have a realistic chance of getting answers about which, if any, of the candidate treatments can save lives in this, and in future outbreaks."
A clinical trial in Liberia to test the antiviral drug brincidofovir has been halted due to problems finding patients. Since the trial started on 2 January, fewer than 10 patients have been treated due to a decline in the number of new cases. The falling numbers of patients is obviously a good thing and the developer of the drug, Chimerix, decided to halt the trial after consultation with investigators at the University of Oxford, the Food and Drug Administration and Doctors without Borders.
The Guardian have a moving account of the time the Oxford scientists spent in Liberia.
After initial results from the Ebola vaccine trial in Oxford showed that the vaccine had an acceptable safety profile, clinical trials of the vaccine in Liberia began on 2 January. The vaccine contains a weakened version of the Ebola virus and it is hoped that it will offer protection against the disease.
The first results from the Ebola vaccine trial carried out by the Jenner Institute found that the vaccine has an acceptable safety profile at the doses tested, and is able to generate an immune response.
Professor Adrian Hill said that: 'The vaccine was well tolerated. Its safety profile is pretty much as we had hoped.'
60 healthy volunteers were vaccinated at the University of Oxford’s Jenner Institute between 17 September and 18 November.
The NEJM paper reports safety data and immune responses for the volunteers for 28 days after immunisation. Follow-up of the vaccinees will continue beyond these initial data until six months after the volunteers received the experimental vaccine.
A clinical trial of a potential treatment for Ebola has started in Liberia, with the first Ebola patient receiving the study drug on 2 January.
Funded by the Wellcome Trust, the trial aims to evaluate the effectiveness of an oral antiviral drug called brincidofovir in patients with Ebola virus disease. Brincidofovir is an experimental drug made by the US company Chimerix in Durham, North Carolina
Professor Peter Horby the trial's chief Investigator, says: 'I'm delighted that the trial has started. It is a tribute to the momentous efforts of the Liberian authorities, MSF, and all the staff working in ELWA3 that we have begun 2015 with real progress towards identifying new treatments for Ebola.
'We can only fully evaluate potential Ebola therapies during an epidemic, and we have shown that this is possible, even during the worst epidemic in living memory.'
Professor Trudie Lang says: 'There are currently no known treatments for Ebola, and so any drugs being given to patients have not been shown to work for Ebola. Giving them on a case by case basis does not enable us to learn whether or not the possible treatments work, therefore it is essential that we run a properly designed trial to be able to test these drugs and see if they are safe and do in fact work.'
The Jenner Institute team led by Professor Adrian Hill have begun testing the safety of a candidate booster vaccine against Ebola, to find out whether it could further increase immune responses. The trial saw 60 people vaccinated between 17 Sep and 18 Nov. Initial results are expected to be published before Christmas, although follow-up of the vaccinees will continue beyond those initial data. 30 of the volunteers are now being invited to receive a second candidate Ebola vaccine of a different type made by Bavarian Nordic, a company based in Denmark. As neither vaccine contains infectious Ebola virus material, they cannot cause a person who is vaccinated to become infected with Ebola.
Professor Hill said: "If a single dose of an Ebola vaccine is sufficient, it makes absolute sense to use that. But it also makes sense at this early stage of trials to see if a second booster vaccine can greatly increase the levels of immune responses produced."
Almost 200 people have received a candidate Ebola vaccine in little more than two months in safety trials carried out in the USA, UK, Mali and Switzerland. At the Jenner Institute within the University of Oxford, the 60th and last healthy volunteer is due to receive the vaccine on Tuesday 18th of November. The Ebola vaccine was developed by the US National Institutes of Health (NIH) and GSK. These first trials in humans have been fast-tracked in response to the current Ebola outbreak. If the safety and immunogenicity data from the Phase 1 trials are promising, the expectation is that the vaccine will move into the next phases of study to further evaluate safety as well as effectiveness in protecting against Ebola infection in African countries.
The Jenner Institute team, led by Professor Adrian Hill has been funded with a £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID). The money will allow the team to start safety tests of the vaccine alongside similar trials in the US run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).
The first out of 60 volunteers to participate in a trial to test whether a new Ebola vaccine produces a good immune response and with few side effects, was vaccinated on 17th September 2014.
Initial results have been promising with all vaccinated volunteers showing no ill effects. As such, the trials have now moved in to Mali, which borders Guinea (where the outbreak began).
The 60th and last volunteer in this trial was vaccinated on 18th November 2014.
A £3.2 million grant from the Wellcome Trust will enable multiple partners around the world, including the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), the University of Oxford, Médecins Sans Frontières (MSF), the World Health Organisation (WHO), Institut Pasteur, Institut Pasteur de Dakar, Fondation Mérieux and the Global Health Network, to quickly establish clinical trials at existing Ebola treatment centres.
Dr Peter Horby of the Centre for Tropical Medicine and Global Health at the University of Oxford and ISARIC is leading this initiative to allow candidate Ebola treatments to be assessed rapidly in patients so that those proving safe and effective may be adopted for use as soon as possible. Dr Horby has now arrived in Guinea and is leading a four-strong group aiming to fast-track trials at treatment centres in West Africa. They are hoping to start the trials some time in November.
The University of Oxford has established a website to provide information and advice on the ongoing Ebola outbreak.
BBC update on West Africa Trials
Read Nick Owen's diary, a participant in the first ever clinical trial for an Ebola Vaccine