Phase 2 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults

Phase 1

• Conditions: Healthy adults; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003714-24-AT
• Lead Sponsor: Biomedizinische Forschung und Bio-Produkte AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-22
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

males or females aged 18-64 years
signed informed consent
physical exam: no abnormal findings unless considered irrelevant by the investigator
uneventful medical history
females with childbearing potential: adequate contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

females with childbearing potential: pregnancy, lactation or unreliable contraception
positive HIV Ab and/or positive HCV Ab and/or positive HBsAG
signs and symptoms of autoimmunity
TSST-1 Ab titer > or = 1:1000
current or recent (< 1 month) immunosuppressive therapy with corticosteroids or immunomodulators

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety and tolerability of two doses of the BioMed rTSST-1 Vaccine after one to three vaccinations in healthy adults;Secondary Objective: Immunogenicity and persistence of TSST-1 binding and neutralizing antibodies after one, two, and three immunizations with two doses of the vaccine in healthy adults over a period of 12-14 or optionally 27-29 months.;Primary end point(s): adverse events<br>abnormal laboratory findings<br>local reactions;Timepoint(s) of evaluation of this end point: 27 - 29 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): TSST-1 binding and neutralizing antibodies<br>persistence of TSST-1 binding and neutralizing antibodies;Timepoint(s) of evaluation of this end point: 27 - 29 months