140
Participants
Start Date
May 31, 2016
Primary Completion Date
May 31, 2020
Study Completion Date
January 31, 2021
rTSST-1v
Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
Medical University of Vienna Department of Clinical Pharmacology, Vienna
Medical University of Vienna
OTHER
Biomedizinische Forschungs gmbH
INDUSTRY