Date: 2014-11-26
Type of information: Publication of results in a medical journal
phase: 1
Announcement: publication of results in the New England Journal of Medicine
Company: GSK (UK) NIH (USA)
Product: Ebola vaccine
Action
mechanism: The candidate vaccine used in the trial conducted by the National Institutes of Health (NIH) was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology company acquired by GSK in 2013. It uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to deliver genetic material from two strains of the Ebola virus – the Sudan strain and the Zaire strain, which is responsible for the current Ebola outbreak in west Africa.
Disease: Ebola fever
Therapeutic area: Infectious diseases
Country: USA, UK, Gambia, Mali
Trial
details: The Oxford study will involve 60 healthy volunteers, while those in The Gambia and Mali will each involve 40. Each set of volunteers will be split into groups of 20 that will receive different doses of the vaccine so researchers can evaluate the best dose to use in terms of both safety and activity.
NIAID are testing this same vaccine in the US, in addition to a related vaccine that is designed to protect against two Ebola species (Ebola Zaire and Ebola Sudan).
Latest
news: * On November 26, 2014, GSK announced that first results from a small phase 1 trial habe been published in the New England Journal of Medicine show that a GSK/NIH Ebola candidate vaccine was well-tolerated and produced an immunological response in each of the 20 healthy adult volunteers in the USA who received it. GSK has been working with the NIH to accelerate development of both this bivalent version of the candidate vaccine and a monovalent version targeting only the Zaire strain in response to the current Ebola epidemic. * On September 17, 2014, the first healthy UK volunteer has received a candidate Ebola vaccine in Oxford in a safety trial carried out by the University of Oxford. Ruth Atkins, a communications and engagement manager in the NHS 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. The UK trial is part of a series of safety trials of potential Ebola vaccines aimed at preventing the disease. It 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). 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. 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. * On August 28, 2014, the Ebola outbreak has already killed more than 1,400 people in West Africa, mainly in Guinea, Liberia, Nigeria, and Sierra Leone. GSK and the US National Institutes of Health (NIH) announced that human trials of their candidate vaccine are to be accelerated with funding from an international consortium in response to the Ebola epidemic, which the World Health Organisation recently declared a public health emergency of international concern. A £2.8 million grant from the Wellcome Trust, the Medical Research Council and the UK Department for International Development will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, 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 phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are granted, the UK research teams could start vaccinating volunteers from mid-September. The consortium’s funding will also enable 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. To accelerate the trials, the NIH has agreed to provide the NIAID/GSK Ebola vaccine for safety studies led by the Oxford team, which will run in parallel to its own trials. If the first volunteers vaccinated in the Oxford study show a good response with no adverse reactions, the trial will, after approval from the relevant authorities, be extended to volunteers at the MRC Unit in The Gambia. A second West African arm of the study, led by Professor Myron M. Levine of the Center for Vaccine Development at the University of Maryland School of Medicine, and Professor Samba Sow of the Center for Vaccine Development in Mali (a joint initiative between the University of Maryland School of Medicine and the Ministry of Health of Mali), will then begin in Bamako, Mali. This collaborative multi-trial approach will help ensure the fastest possible progress to determining the best candidate vaccine approach and delivery. The addition of West African arms will also ensure that the studies take account of differences between European and West African populations that might affect safety or immune response.
Commenting on the results, Dr Moncef Slaoui, Chairman of Global Vaccines at GSK said: “We are very encouraged by these positive first trial results showing this type of vaccine has an acceptable safety profile and can produce an immune response against Ebola in humans. (...) It’s important to remember that these data are the first piece in the jigsaw and we’re continuing to gather other important information. Over the coming weeks, we will see results from further phase 1 trials which will tell us more about the profile of the monovalent vaccine; most significantly results from a trial in Mali which is assessing its safety and immune response in west African populations."
If trials are successful, the next phases of the clinical trial programme will begin in early 2015 which will involve the vaccination of thousands of frontline healthcare workers in the two of the affected countries – Sierra Leone and Liberia. Further safety studies will also be conducted in west African countries not affected by the current outbreak in adults and children.
* On October 18, 2014, GSK announced that first phase 1 safety trials with the vaccine candidate are underway in the USA, UK and Mali, and further trials due to start in the coming weeks. Initial data from the phase 1 trials are expected by the end of the year and if successful, the next phases of the clinical trial programme will begin in early 2015 which will involve the vaccination of thousands of frontline healthcare workers in the three affected countries – Sierra Leone, Guinea and Liberia. If the vaccine candidate is able to protect these healthcare workers as we hope it will, it could significantly contribute to efforts to bring this epidemic under control. Beyond this, GSK is working with the WHO, regulators and other stakeholders to determine how and when near term supplies of the Ebola vaccine could be made available for targeted vaccination of additional health care workers and other people at high risk of infection in the affected countrieswhere the impact would be most likely to limit the further spread of the epidemic. Its future use in mass vaccination campaigns will depend on whether the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large enough quantities can be made.
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.
