ABOUT THE VACCINE
It is very important for you to know that the vaccine that we are testing does not have the tuberculosis bacteria in it but rather small proteins that we hope will 'wake up' your immune system and may protect people from getting TB. Because this is a phase 1 study (which means it is the first time it is being tested in people, although we have shown it works to protect animals against getting TB), we don't know yet if it will prevent TB in people. In this study, we want to test the vaccine on healthy people first to see if it is safe and see if we can measure anything in your blood, sputum and lungs that could mean that this vaccine would work.
The way this works is by using a very smart and innovative way of presenting the tuberculosis protein to the body; this is what is called a recombinant adenovirus based vaccine, and what it basically means is that the vaccine contains a virus called adenovirus (which is a common type of virus that causes the common cold in children around the world). You have most probably felt some cold symptoms before, and in more than one occasion an adenovirus would have been the culprit.
We will use a weak strain of an adenovirus and 'mount' the tuberculosis genes on to it. The weakened viruses will be living in a special solution that will be 'nebulized' so you can breathe it. FYI one of our secondary goals is to develop a needle-free vaccine.
This innovative technique is what is called adenoviral technology/gene transfer. This technology has been used in other vaccine studies and has proven to be safe and effective in human participants.
McMaster University Medical Center - Department of Pathology
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