The farther the Ebola vaccine and the development reached a critical and sharp step closer to entering the large-scale efficacy trials in West Africa hard hit by the current epidemic.
As reported online today in The New England Journal of Medicine ( NEJM ), a US study conducted in 20 healthy people with no risk to develop the disease found the vaccine did not cause any serious side effects and, as expected, triggered immune responses against the Ebola virus. The vaccine, jointly developed by GlaxoSmithKline (GSK) and the National Institute of Allergy and Infectious Diseases of the United States (NIAID), contains a gene for Ebola surface protein sewn inside a harmless adenovirus chimpanzee. NIAID researchers in Bethesda, Maryland, began the trial on 2 September, and the development of super-fast-track vaccine could move in trials involving 15,000 people in Liberia and high risk in Sierra Leone to develop the disease by mid -January, NIAID Director Anthony Fauci said science Insider.
other small studies of the vaccine, which together involved 260 people, are underway in Mali, the United Kingdom, and Switzerland and should produce data by the end of next month. Ripley Ballou, who heads the Ebola vaccine development for GSK, said Science Insider that the company needs these data before finalizing plans for efficacy studies. In particular, Ballou said that clinical trials should clarify what dose of the vaccine will trigger the strongest immune responses without side effects
The NEJM describes the results of two different doses: a more impressive antibody and T cell responses were triggered, but it also caused "transient fever" in two recipients. Fever is an early symptom of the Ebola virus itself, and a vaccine that raises the body temperature could lead the beneficiaries to worry unnecessarily that they develop the disease. "It is clear that we want to select a dose that is both immunogenic and has an acceptable reactogenicity profile, including a rate of low fever," says Ballou, who is based in Rixensart, Belgium. Ongoing trials also evaluate a dose between the two used in the NIAID trial.
Fauci said he did not hesitate to move forward with the highest dose used in the study NIAID. "obviously, we would like see no fever, but the fact that we had two fevers that lasted less than 24 hours does not bother me, "Fauci said." We see the passing fevers with other vaccines. "
Similar small-scale testing of a second Ebola vaccine began in October; Results are expected by December that will determine whether to move into efficacy trials, and at what dose. This vaccine, licensed by the Canadian government to NewLink Genetics Ames, Iowa, contains the gene for the sewn Ebola surface protein in a weakened version of the virus of the vesicular stomatitis virus (VSV), a pathogen that causes disease in the cattle. NewLink, a small start-up that focuses primarily on cancer drugs and has no products on the market has been somewhat in the shadow of GSK, a big pharma. But on 24 November, NewLink and pharmaceutical giant Merck of Whitehouse Station, New Jersey, announced that they have entered a licensing agreement for joint research and develop VSV Ebola vaccine.
The results of these studies could be effective by April 2015. If vaccines protect people from Ebola and appear safe, an urgent question will surface: Is GSK and Merck enough doses produced then vaccinate enough people-which could mean hundreds of thousands or even millions to help bring this epidemic to an end
* Ebola files: given epidemic of Ebola current, unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research articles and new on viral disease available for researchers and the general public.
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