GSK is set to begin a clinical trial of an experimental vaccine against Ebola, jointly with American scientists.
The experimental vaccine has already produced promising results in animal studies, and with an approval from the FDA, it will enter initial Phase I testing in humans.
Still, the new vaccine will not be ready for widespread deployment before 2015 - even assuming it works as well as hoped.
I wonder about that design of the study, assuming that the phase 1 will safe then how the phase 2a dose finding and phase 2b proof of concept will be conducted, knowing that a large sample size will be requires. How can we predict the outbreak? And where will be the setting for this complex trial?
Appart of safety, which is inescapable, whatever the sort of evidence that it protects will bee good enough, given the characteristics of the virus and the ilness. Tis is not any virus.
I agree with Ruchi and for the numbers needed, that again depend on the trial outcome that you want to consider and there are ways of handling studies where one cannot get huge numbers. For instance, the use of models based on results of the trial and the epidemiology of the outbreaks which is currently studied.
Please go this link: https://clinicaltrials.gov/ct2/home
In the search box, type "ebola"
You can see the clinical trials of vaccines for ebola that have been completed and/or in progress since 2006.
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