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Amendment of Phase 1 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
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.
Details
| Lead sponsor | Biomedizinische Forschungs gmbH |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2015-10 |
| Completion | 2016-05 |
Conditions
- Toxic-Shock Syndrome
- Sepsis
Interventions
- rTSST-1 Variant Candidate Vaccine
Primary outcomes
- Number of Participants With Adverse Events as a Measure of Safety — through 6 months
Clinical observation and clinical laboratory values - Persistence of TSST-1 Antibodies — 6-15 months after last immunization of Phase I
ELISA IgG against rTSST-1. Persistence of antibody was defined as a \>/= 4-fold increase in TSST-1 Ab titer as compared to pre-vaccination values.