At a glance
ClinicalIndex Comparison Record- ✓Age 18–64 years
- ✓Male or female
- ✓Uneventful medical history
- ✓Normal physical examination or abnormalities deemed irrelevant by investigator
- ✕Pregnancy
- ✕Positive virology markers at initial screening
- ✕Signs and symptoms of relevant autoimmunity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Amendment of Phase 1 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating rTSST-1 Variant Candidate Vaccine for Toxic-Shock Syndrome and Sepsis. Completed, enrolled 23 participants.
Detailed Summary
Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible for almost all of menstruation associated and more than 50% of all other cases. There is no specific therapy. The Phase I study BioMed0713 demonstrated the safety and tolerability of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The aim of this amendment is to demonstrate prolonged safety of the BioMed rTSST-1 Variant Vaccine and to assess persistence of antibodies generated in participants. The second aim of the study is to assess boosterability of the BioMed rTSST-1 Variant Vaccine.
Study Details
Timeline
Interventions
Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I.