At a glance
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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 Vaccination; Sepsis. Completed, enrolled 46 participants across 1 site.
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 aim of this study is to demonstrate the safety and tolerability of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The second aim of the study is to measure antibodies in the blood of these healthy volunteers which have been produced in response to treatment with the BioMed rTSST-1 Variant Vaccine. These antibodies are expected to be important in resistance against the diseases. 46 healthy adults, male and female, age 18-64 years will be assigned to 6 dose groups of the vaccine at the Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for vital signs, hematology, clinical chemistry, blood cytokine level and antibodies against TSST-1. Immunization will be repeated 4 weeks after the first with the same dose.
Study Details
Timeline
Interventions
In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.