Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial

NCT02971670 | Completed Phase 1 Results DMC

• 1 other identifier: BioMed0713 B
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Toxic-Shock Syndrome; Sepsis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events as a Measure of Safety

  Clinical observation and clinical laboratory values

  through 6 months

• Persistence of TSST-1 Antibodies

  ELISA IgG against rTSST-1. Persistence of antibody was defined as a \>/= 4-fold increase in TSST-1 Ab titer as compared to pre-vaccination values.

  6-15 months after last immunization of Phase I

Secondary Outcomes (1)

• Boosterability of BioMed rTSST-1 Variant Vaccine

  through 6 months after third immunization

Study Arms (4)

Dose Group 1

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 3 µg

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 2

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 10 µg

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 3

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 30 µg

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 0

PLACEBO COMPARATOR

Control: Al(OH)3 Adjuvant

Biological: rTSST-1 Variant Candidate Vaccine

Interventions

rTSST-1 Variant Candidate Vaccine BIOLOGICAL

Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I.

Dose Group 0; Dose Group 1; Dose Group 2; Dose Group 3

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

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 Forschungsgesellschaft mbH

martha.eibl@meduniwien.ac.at

+43-1-4081091

Study Officials

• Martha M Eibl, MD

  Biomedizinische ForschungsgmbH

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 9, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share