ClinicalTrials.gg
Sign In
CompletedNCT02971670Updated Jun 9, 2017Results posted

Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial

A Phase 1 interventional study of rTSST-1 Variant Candidate Vaccine in Toxic-Shock Syndrome and Sepsis, sponsored by Biomedizinische Forschungs gmbH. Completed. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-09.

Sponsored by Biomedizinische Forschungs gmbH · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Toxic-Shock Syndrome
  • Sepsis
03

In context

Shock, Septic

890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.

This study's enrollment of 23 is below the median of 78 across 547 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Biomedizinische Forschungs gmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnancy
  • positive virology markers at first screening
  • signs and symptoms of relevant autoimmunity
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Dose Group 1

    Treatment: rTSST-1 Variant Candidate Vaccine 3 µg

    Biological: rTSST-1 Variant Candidate Vaccine

  • Experimental
    Dose Group 2

    Treatment: rTSST-1 Variant Candidate Vaccine 10 µg

    Biological: rTSST-1 Variant Candidate Vaccine

  • Experimental
    Dose Group 3

    Treatment: rTSST-1 Variant Candidate Vaccine 30 µg

    Biological: rTSST-1 Variant Candidate Vaccine

  • Placebo comparator
    Dose Group 0

    Control: Al(OH)3 Adjuvant

    Biological: rTSST-1 Variant Candidate Vaccine

Interventions

  • BiologicalrTSST-1 Variant Candidate Vaccine

    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.

06

What researchers measure

Primary outcomes

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

    Clinical observation and clinical laboratory values

    Time frame: through 6 months

  2. 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.

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

Secondary outcomes

  1. Boosterability of BioMed rTSST-1 Variant Vaccine

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

    Time frame: through 6 months after third immunization

07

Results

Posted May 8, 2017

Participant flow

Participant flow — Overall Study
MilestoneDose Group 1Dose Group 2Dose Group 3Dose Group 0
Started13253
Completed9141
Not completed4112
Withdrew: Withdrawal by subject4112

Outcome measures

PrimaryNumber of Participants With Adverse Events as a Measure of Safety

Clinical observation and clinical laboratory values

Time frame:
through 6 months
Reported as:
Number · participants
Number of Participants With Adverse Events as a Measure of Safety
participantsDose Group 1Dose Group 2Dose Group 3Dose Group 0
Number of Participants With Adverse Events as a Measure of Safety7110
PrimaryPersistence 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.

Time frame:
6-15 months after last immunization of Phase I
Reported as:
Count of participants · Participants
Persistence of TSST-1 Antibodies
ParticipantsDose Group 1Dose Group 2Dose Group 3Dose Group 0
Persistence of TSST-1 Antibodies9230
SecondaryBoosterability of BioMed rTSST-1 Variant Vaccine

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

Time frame:
through 6 months after third immunization
Reported as:
Count of participants · Participants
Boosterability of BioMed rTSST-1 Variant Vaccine
ParticipantsDose Group 1Dose Group 2Dose Group 3Dose Group 0
Boosterability of BioMed rTSST-1 Variant Vaccine8140

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dose Group 1—1/9 (11.1%)7/9 (77.8%)
Dose Group 2—0/1 (0%)1/1 (100%)
Dose Group 3—0/4 (0%)1/4 (25%)
Dose Group 0—0/1 (0%)0/1 (0%)
Most frequent serious events
Most frequent serious events
EventDose Group 1Dose Group 2Dose Group 3Dose Group 0
Non-drug-related HospitalizationInjury, poisoning and procedural complications1/90/10/40/1
Most frequent other events
Most frequent other events
EventDose Group 1Dose Group 2Dose Group 3Dose Group 0
Mild to moderate reactionsGeneral disorders7/91/11/40/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dose Group 1Dose Group 2Dose Group 3Dose Group 0Total
<=18 years00000
Between 18 and 65 years1325323
>=65 years00000
Age, Continuous
Age, Continuous(years)Dose Group 1Dose Group 2Dose Group 3Dose Group 0Total
Mean38.5 ± 10.145 ± 18.428.6 ± 7.931.3 ± 10.735.9 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Dose Group 1Dose Group 2Dose Group 3Dose Group 0Total
Female614314
Male71109
Region of Enrollment
Region of Enrollment(Participants)Dose Group 1Dose Group 2Dose Group 3Dose Group 0Total
Austria1325323
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2015, a primary completion of Mar 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

Results were first posted in May 2017, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2016
First posted
Nov 23, 2016
Start
Oct 2015
Primary completionActual
Mar 2016
CompletionActual
May 2016
Results first posted
May 8, 2017
Last update
Jun 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02971670
Lead sponsor
Biomedizinische Forschungs gmbH
Collaborators
Medical University of Vienna
Responsible party
Sponsor
First posted
Nov 23, 2016
Start date
Oct 2015
Primary completion
Mar 2016
Completion
May 2016
Results posted
May 8, 2017
Last update
Jun 9, 2017

Study contacts

Martha M Eibl, MD
study director · Biomedizinische ForschungsgmbH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Shock, Septic →

Other studies from this sponsor

Biomedizinische Forschungs gmbH

Start the discussion