Adenovirus gene therapies have been studied in many human trials and have been found to be well tolerated and associated with very few side effects.
This aerosol vaccine that we are testing has mild side effects, that have been reported in other studies, when administered to healthy participants. They can include:
Flu-like symptoms such as fatigue (15-23%), chills (5-29%), fever (5-35%), headaches (22-42%), and muscle aches (5-16%) , cough, wheezing, sneezing, shortness of breath, chest pain, malaise, conjunctivitis, rhinitis, syncope, or nose bleeding have been observed after administration of the vaccine. Most side effects were improved within 24 hours and are expected to be no more than mild or moderate.
Because you have previously had BCG vaccination, you may have a small number of immune cells that might react when you are given the vaccine. This might cause some inflammation in the lungs that you will be closely watched for but it is not expected that you would get any breathing problems or other symptoms.
In our recently completed study when the vaccine was administered into the muscle, the vaccine was found to be safe and well-tolerated. There were no vaccine-related serious side effects. Most common side effects were local reactions at the site of injection including pain and redness which were mild to moderate and were gone after 24 hours.