Phase 1 Completed N=23 Single-blind Treatment

Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial

Toxic-Shock Syndrome · Sepsis

Source: ClinicalTrials.gov NCT02971670 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

May 2017

Primary outcomePrimary: Number of Participants With Adverse Events as a Measure of Safety — 7; 1; 1; 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events as a Measure of Safety	7; 1; 1; 0	—
PRIMARY Persistence of TSST-1 Antibodies	9; 2; 3; 0	—
SECONDARY Boosterability of BioMed rTSST-1 Variant Vaccine	8; 1; 4; 0	—

Eligibility Criteria

Inclusion Criteria

male and female
18 - 64 years
written informed consent
physical exam: no abnormal findings unless considered irrelevant by the investigator
uneventful medical history
females: adequate contraception

Exclusion Criteria

pregnancy
positive virology markers at first screening
signs and symptoms of relevant autoimmunity

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02971670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.