Date: 4 Dec 2014 Source: CIDRAP [edited] cidrap.umn.edu/news-perspective/2014/12/groups-report-early-safety-data-progress-ebola-vaccines Indications from early human trials of an Ebola vaccine developed by Canadian scientists show no serious adverse reactions so far, according to Swiss researchers, as a research team from the United Kingdom announced the launch of a prime-boost study of another Ebola vaccine developed by the US National Institutes of Health (NIH) and drug maker GSK. Canada: VSV-EBOV -------------- For the Canadian-developed vaccine, some volunteers experienced mild to moderate inflammatory reactions, according to a machine translation of a 2 Dec 2014 press release in French from University Hospitals of Geneva (HUG) where the trial is underway. The vaccine, called VSV-EBOV, uses an Ebola virus protein spliced into a vesicular stomatitis virus (VSV). NewLink Genetics, a small pharmaceutical company based in Ames, Iowa obtained the marketing rights to the vaccine from the Public Health Agency of Canada in 2010, but on 24 Nov [2014] announced a deal with Merck designed to tap into the larger companys capacity and expertise to get the vaccine through testing, regulatory approval, and production. USA/GSK: ChAD3 ------------- VSV-EBOV is one of 2 Ebola vaccines that are furthest along in clinical trials. The other, called ChAD3, uses a modified chimpanzee adenovirus and was developed by the US National Institute of Allergy and Infectious Diseases (NIAID) at the NIH and by GSK. Research studies have suggested that the Canadian vaccine would require only one dose, compared with 2 doses that may be needed for the NIH-GSK vaccine. So far, 34 of 115 people at HUG (University Hospitals of Geneva) have been immunized. Participants received an injection containing a lower or higher dose or placebo. All were carefully monitored for an hour and a half after injection, and they were asked to record any symptoms during the week after. They returned to the clinical center for monitoring and sampling on days 1, 2, 3, and 7. The reactions reported were expected and temporary, lasting a few hours to 2 or 3 days. The trial continues through early 2015, with 15 more volunteers vaccinated each week, according to the statement. Clinical trials of the VSV-EBOV are also underway in Canada, the United States, Germany, and Gabon, and should start soon in Kenya. United Kingdom: MVA-BN Filo ------------------------ In the other vaccine trial development, researchers at the University of Oxford in the United Kingdom today [4 Dec 2014] announced the launch of a trial to see whether a booster vaccine can increase the immune response to a monovalent version of ChAD3. The vaccine in the Oxford trials contains genetic material from the Zaire species of Ebola, the strain causing West Africas outbreak. Initial results from the 1st human trial of a version of ChAD3 designed to protect the Zaire and Sudan Ebola strains, published last week, showed promising safety and immunogenicity findings. In a statement today [4 Dec 2014], the university said 30/60 people who have been vaccinated in ongoing trials of ChAD3 were invited to receive a 2nd candidate Ebola vaccine made by Danish pharmaceutical company Bavarian Nordic. The trial is testing the safety of the booster given 3-10 weeks after vaccination with ChAD3, and researchers will measure immune responses over 6 months. The booster vaccine, called multivalent MVA-BN Filo, is designed to protect against the Zaire and Sudan Ebola strains and Marburg virus, another member of the filovirus family, according to a press release today [4 Dec 2014] from Bavarian Nordic. The company said recent preclinical studies suggested that an MVA-based booster dose may offer a stronger and more durable immune response. Adrian Hill, MD, PhD, who is leading the trial, said in the statement that the goal of this arm of the trial is to gauge the safety of the 2 Ebola vaccines used together, as well as the immune response. 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 whether a 2nd booster vaccine can greatly increase the levels of immune responses produced, Hill said in the statement. He added that there is a lot of uncertainty about the levels of immunity that are needed to protect people against Ebola. The more data we have, the more we can make good decisions on what is likely to be safe, what may offer best chance of protection and what is feasible and achievable, he said. Researchers expect to publish their initial findings by Christmas [2014], according to the statement... - more [Byline: Lisa Schnirring] -- Communicated by: ProMED-mail
Posted on: Tue, 09 Dec 2014 14:38:23 +0000
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