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

NCT02814708 | Completed Phase 2 Results DMC

• 1 other identifier: BioMed 0515
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality 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 extend the safety and tolerability of two doses of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and persistence of antibodies which produced in response to treatment with the BioMed rTSST-1 Variant Vaccine over a period of 12 months. These antibodies are expected to be important in prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64 years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1. Immunization will be repeated 3 months after the first with the same dose and 6 months after the second immunization in the respective groups. Antibodies will be determined through monitoring TSST-1 binding antibodies as assessed through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition of T cell activation (3H Thymidine incorporation; ≥ 50%).

Conditions

Toxic Shock Syndrome

Keywords

Sepsis; Vaccination

Outcome Measures

Primary Outcomes (1)

• Number of Participants (Percentage) With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  12 months and 18 months follow up

Secondary Outcomes (1)

• Number of Participants With a Fold Increase of ELISA IgG Against rTSST-1

  12 months and 18 months follow up

Study Arms (7)

Dose Group 1

EXPERIMENTAL

rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1

Biological: rTSST-1v

Dose Group 2

EXPERIMENTAL

rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2

Biological: rTSST-1v

Dose Group 3

EXPERIMENTAL

rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3

Biological: rTSST-1v

Dose Group 4

EXPERIMENTAL

rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1

Biological: rTSST-1v

Dose Group 5

EXPERIMENTAL

rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2

Biological: rTSST-1v

Dose Group 6

EXPERIMENTAL

rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3

Biological: rTSST-1v

Dose Group 7

PLACEBO COMPARATOR

Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3

Biological: rTSST-1v

Interventions

rTSST-1v BIOLOGICAL

Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .

Dose Group 1; Dose Group 2; Dose Group 3; Dose Group 4; Dose Group 5; Dose Group 6; Dose Group 7

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \> 1:1000
• current or recent (\< 1 month) immunosuppressive therapy with corticosteroids or immunomodulators

Sponsors & Collaborators

• Biomedizinische Forschungs gmbH: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Related Publications (2)

• Schwameis M, Roppenser B, Firbas C, Gruener CS, Model N, Stich N, Roetzer A, Buchtele N, Jilma B, Eibl MM. Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man trial. Lancet Infect Dis. 2016 Sep;16(9):1036-1044. doi: 10.1016/S1473-3099(16)30115-3. Epub 2016 Jun 10.

  PMID: 27296693 RESULT

• Schoergenhofer C, Gelbenegger G, Hasanacevic D, Schoner L, Steiner MM, Firbas C, Buchtele N, Derhaschnig U, Tanzmann A, Model N, Larcher-Senn J, Drost M, Eibl MM, Roetzer A, Jilma B. A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results. EClinicalMedicine. 2024 Jan 5;67:102404. doi: 10.1016/j.eclinm.2023.102404. eCollection 2024 Jan.

  PMID: 38274114 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Dr. Martha M. Eibl
• Organization: Biomedizinische Forschung & Bio-Produkte AG

martha.eibl@meduniwien.ac.at

+43-1-4081091

Study Officials

• Martha M Eibl, MD

  Biomedizinische Forschungsgmbh

  STUDY DIRECTOR

• Bernd Jilma, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two different doses of rTSST-1 Variant Vaccine were tested in different administrational schedules. These were: a comparison of 10µg versus 100µg rTSST-1 Variant Vaccine administered one, two, or three times.

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 4, 2022
• Results First Posted: December 13, 2021

Record last verified: 2021-12

Locations

AU (1)