rTSST-1 Variant Vaccine Phase 1 First-in-man Trail

NCT02340338 | Completed Phase 1 Results DMC

• 1 other identifier: BioMed0713
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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 aim of this study is to demonstrate the safety and tolerability of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The second aim of the study is to measure antibodies in the blood of these healthy volunteers which have been produced in response to treatment with the BioMed rTSST-1 Variant Vaccine. These antibodies are expected to be important in resistance against the diseases. 46 healthy adults, male and female, age 18-64 years will be assigned to 6 dose groups of the vaccine at the Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for vital signs, hematology, clinical chemistry, blood cytokine level and antibodies against TSST-1. Immunization will be repeated 4 weeks after the first with the same dose.

Conditions

Toxic Shock Syndrome; Vaccination; Sepsis

Outcome Measures

Primary Outcomes (1)

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

  Clinical observations and clinical laboratory values

  through day 70

Secondary Outcomes (1)

• Number of Participants With Seroconversion

  through day 70

Study Arms (7)

Dose Group 1

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 100 ng

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 2

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 300 ng

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 3

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 1 µg

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 4

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 3 µg

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 5

EXPERIMENTAL

Treatment: rTSST-1 Variant Candidate Vaccine 10 µg

Biological: rTSST-1 Variant Candidate Vaccine

Dose Group 6

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

In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.

Dose Group 0; Dose Group 1; Dose Group 2; Dose Group 3; Dose Group 4; Dose Group 5; Dose Group 6

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
• signs and symptoms of relevant autoimmunity
• TSST-1 Ab titer \> 1:2000

Sponsors & Collaborators

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

Study Sites (1)

Medical University of Vienna Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• 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 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 Forschungsgesellschaft mbH

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 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: January 16, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)