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What trials are ongoing in ebola?
It is well reported that conducting research during disease outbreaks is incredibly challenging, and often not a single trial is completed while an outbreak occurs (see http://www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pntd.0000335. However, the ebola outbreak has seen commercial and non-commercial groups joining to fast-track protocol development and trial operations, with two vaccine trials currently ongoing and drug trials likely to start shortly. The WHO’s decision to allow human application of ZMapp received a lot of press coverage, as did the initiation of a vaccine trial in Oxford University, but ongoing news and information about the trials being done into ebola is harder to come by. Below we have summarised the ongoing research projects, and we will continue to update this as more information and research come to light.
www.clinicaltrials.gov lists only two recruiting trials, both for vaccine candidates.
A Study to Assess a New Ebola Vaccine, cAd3-EBO Z. Oxford University, funded by the Wellcome Trust, Oxford University and NIAID, is currently trialling a candidate ebola vaccine to establish safety and immune response of healthy volunteers. The team is led by Professor Adrian Hill at the Jenner Institute, and the fast-tracked vaccine is being trialled initially in volunteers in Oxford to establish safety data. It will be extended to testing in the MRC Unit in the Gambia and other sites in West Africa once initial safety data has been gained. This is not a live vaccine trial; instead, one gene of the ebola virus – the gene that codes for the outer coating of the virus (a glycoprotein) – is spliced into the DNA of a chimp adenovirus (common cold). The idea is that this harmless virus then infects a human cell and the cell pumps out more of the ebola glycoprotein (but therefore does not actually infect the person with ebola). The immune system therefore learns to respond to the glycoprotein, therefore theoretically enabling it to reproduce this response if the body is exposed to the actual virus.
The vaccine was co-developed by the US National Institute of Health and GSK, and showed promising results with chimpanzees (http://www.nature.com/nm/journal/vaop/ncurrent/full/nm.3702.html).
You can read more about this trial here: http://clinicaltrials.gov/ct2/show/NCT02240875?term=ebola&rank=2And articles in the general media here:
Safety, Tolerability and Immunogenicity of ebola Chimpanzee Adenovirus Vector Vacine (cAd2-EBO) in healthy adultsThis NIAID study is testing a similar strain to the candidate vaccine trial above, but in the US. If successful, both vaccines could be in use. The Principal Investigator is Julie Ledgerwood of the NIH in Maryland, and the first two patients were given the vaccine on September the 4th. This smaller study will test only twenty volunteers in the first instance. The planned completion date is December 2015.
There are some reports of other groups, for example Johnson and Johnson, planning fast-track vaccine trials, but no official information or registered trials as yet.
Therapeutic Drug Candidates
There are a couple of therapeutic drug candidates, with ZMapp being the most well known.
ZMapp is a potential therapeutic drug being developed by Mapp Biopharmaceutical Inc., and is a blend of three lab-made antibodies which are designed to neutralise the virus, and was first identified in January 2014. Following the successful use of ZMapp when treating ebola-infected monkeys, the WHO famously decided to allow the use of ZMapp in infected humans, prior to any human trials occurring. The non-human trials showed 100% efficacy in reversing ebola, even when the primates were given the drug five days after infection with lethal levels of the ebola virus. Peter Piot, the discoverer of the ebola virus and director of the London School of Hygiene and Tropical Medicine, said that this was a well-designed trial and provided ‘the most convincing evidence to date that ZMapp may be an effective treatment of ebola in humans’. You can read more here: Nature article of results of non-human primates infected with ZMapp “Reversion of advanced Ebola virus disease in nonhuman primates with ZMapp"
http://www.pharmaceutical-journal.com/news-and-analysis/news/positive-results-in-monkeys-from-first-zmapp-trial-to-treat-ebola/20066303.articleVarious groups are reportedly trialling ZMapp in the field, as well as other drugs, but official information into these trials is not yet available.
Another potential candidate is Brincidofovir - an antiviral drug, which is already in late-stage trials for another indication and manufactured by the American company Chimerix. It has been used to treat critically ill returning health workers in the States and appears promising so far.
No trial registrations have yet been made for Brincidofovir.
We will update information about new and ongoing trials as frequently as possible.
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Are you working on an ebola trial? Please share your experiences and thoughts.
What trials are ongoing in ebola
See above :-)