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NCT Number: NCT02971670

Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial

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.

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Key information

Conditions

Toxic-Shock Syndrome Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

The BioMed rTSST-1 Variant Vaccine has been developed by Biomedizinische ForschungsgmbH as one component of a polyvalent staphylococcal vaccine for the prevention of toxic shock and hyperimmunization of donors for the production of TSST-1 immunoglobulin.

This is a prospective, single-blinded follow-up study of the safety and immunogenicity of the BioMed rTSST1 Variant Vaccine compared to adjuvant in healthy adults.

All subjects who received 2 doses of 100 ng or more of the rTSST-1 Variant Candidate Vaccine or placebo (Groups 1 - 6) will be followed up in a single-blinded manner for long-term immunogenicity 6 - 15 months after their last (= second) immunization to gain more data about persistence of TSST-1 Ab titer. As this part of the study occurs after unblinding of the study subjects, it is termed Part B (for better discrimination from double-blinded Part A).

All participants will be invited for a blood withdrawal to determine TSST-1 antibodies. Independent of the TSST-1 Ab titer level, subjects will receive one booster immunization either according to their former allocated dose (group 4: 3µg or placebo, group 5: 10 µg or placebo, group 6: 30 µg or placebo) or 3µg or placebo (groups 1 - 3) in the same visit.

Placebo will be administered according to the former allocated dose.

The treated subjects will stay two hours after immunization at the department and will be followed up for 6 months.

Rationale for reduced monitoring after immunization and follow up:

The BioMed rTSST-1 Variant Vaccine demonstrated excellent local and systemic tolerability and safety and an absence of adverse events classified as clinically relevant during the conduct of the study. Therefore no abnormal findings are expected and the monitoring of the vaccinated subjects after immunization is reduced to two hours, there are three follow up visits planned, 24h (+-2 h), 28 days (+-7 days) and 6 months (+-28 days) after booster vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male and female
  • 18 - 64 years
  • written informed consent
  • physical exam: no abnormal findings unless considered irrelevant by the investigator
  • uneventful medical history
  • females: adequate contraception

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety

    Time frame: through 6 months

    Clinical observation and clinical laboratory values

  2. Persistence of TSST-1 Antibodies

    Time frame: 6-15 months after last immunization of Phase I

    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.

Secondary outcomes

  1. Boosterability of BioMed rTSST-1 Variant Vaccine

    Time frame: through 6 months after third immunization

    ELISA IgG against rTSST-1. Boosterability was defined as an increase in TSST-1 Ab titer as compared to antibody titers after second vaccination.

Sponsors and collaborators

Lead sponsor

Biomedizinische Forschungs gmbH

Industry

Collaborators

  • Medical University of Vienna

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 23, 2016
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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