Open, controlled monocentric clinical study to evaluate the specific immune responses against Salmonella Typhi porins after vaccination with the commercial live oral typhoid vaccine Ty21a Vivotif®

Kantonsspital St.Gallen Hospital0 个研究点目标入组 20 人开始时间: 2015年8月13日最近更新: 2023年9月18日

适应症

试验速览

•1. Ability to understand the experimental nature of the vaccine evaluation and the participant informed consent form
•2. Written informed consent documented by date and signature to be obtained prior to any study specific procedure
•3. Age 18-50 years old
•4. Regular bowel movement (1+ defecation per day)
•5. Willingness to adhere to the strict timing schedule for the study evaluation
•6. Willingness to provide stool and blood samples in the indicated visits

•1. Previous use of an oral vaccine against Salmonella in the past three years
•2. Gastrointestinal infection caused by any Salmonella species during the past 3 years
•3. Positive HIV serology or any known immune deficiency
•4. Current or planned pregnancy during the course of the study
•5. Unwillingness to use at least one method of birth control in women of childbearing age during the course of the study
•6. Are breastfeeding
•7. Suffer from obstipation
•8. Suffer from hypersensitivity to any component of the vaccine or the enteric-coated capsule
•9. Use of an immune modulator in the past year
•10. Use of systemic corticosteroid treatment in the past 30 days
•11. Use of antibiotics within 1 week preceding and during the present study
•12. Current use of proton-pump inhibitors
•13. Participation in another study with investigational drug within the 30 days preceding and during the present study

发起方

Kantonsspital St.Gallen Hospital