Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

May 31, 2020

Study Completion Date

January 31, 2021

Conditions
Toxic Shock Syndrome
Interventions
BIOLOGICAL

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 .

Trial Locations (1)

1090

Medical University of Vienna Department of Clinical Pharmacology, Vienna

All Listed Sponsors
collaborator

Medical University of Vienna

OTHER

lead

Biomedizinische Forschungs gmbH

INDUSTRY

NCT02814708 - Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults | Biotech Hunter | Biotech Hunter