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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003714-24-AT

Enrollment

140

Registered

2015-10-22

Start date

2016-03-29

Completion date

Unknown

Last updated

2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Product Name: rTSST-1 Variant Vaccine Pharmaceutical Form: Suspension for injection INN or Proposed INN: not available Current Sponsor code: ORG28077 Other descriptive name: RTSST-1 VARIANT Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 abnormal laboratory findings local reactions;Timepoint(s) of evaluation of this end point: 27 - 29 months	—

Measure

Time frame

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 abnormal laboratory findings local reactions;Timepoint(s) of evaluation of this end point: 27 - 29 months

—

Secondary

Measure	Time frame
Secondary end point(s): TSST-1 binding and neutralizing antibodies persistence of TSST-1 binding and neutralizing antibodies;Timepoint(s) of evaluation of this end point: 27 - 29 months	—

Countries

Austria

Contacts

Public ContactCEO

Biomedizinische Forschung und Bio-Produkte AG

office@biomed-research.at431408109111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 9, 2026