 Medical occurrences that are symptoms of existing disease, and that do represent an exacerbation of that disease, or the PCI procedure are not defined as AEs in this clinical trial. Also elective hospitalisations for pre-treatment conditions are not AEs nor expected reactions to vaccination, such as but not limited to, redness, swelling, pain, fever and chills. AEs not to be reported are also those defined as study endpoints. An IEC will evaluate for safety after 1000 patients. 