Toxic-Shock SyndromePhase 1NCT02971670
Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial
A Phase 1 study testing rTSST-1 Variant Candidate Vaccine in people with Toxic-Shock Syndrome and Sepsis, run by Biomedizinische Forschungs gmbH.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Toxic-Shock Syndrome, Sepsis
- What is being tested?
- rTSST-1 Variant Candidate Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- positive virology markers at first screening
- signs and symptoms of relevant autoimmunity
About this study
Official title: Amendment of Phase 1 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
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.
- Conditions
- Toxic-Shock Syndrome, Sepsis
- Being tested
- rTSST-1 Variant Candidate Vaccine
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTSST-1 Variant Candidate VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 | Experimental | Treatment: rTSST-1 Variant Candidate Vaccine 3 µg Receives: Biological: rTSST-1 Variant Candidate Vaccine |
| Dose Group 2 | Experimental | Treatment: rTSST-1 Variant Candidate Vaccine 10 µg Receives: Biological: rTSST-1 Variant Candidate Vaccine |
| Dose Group 3 | Experimental | Treatment: rTSST-1 Variant Candidate Vaccine 30 µg Receives: Biological: rTSST-1 Variant Candidate Vaccine |
| Dose Group 0 | Placebo comparator | Control: Al(OH)3 Adjuvant Receives: Biological: rTSST-1 Variant Candidate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety
Clinical observation and clinical laboratory values
Measured: 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.
Measured: 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.
Measured: through 6 months after third immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Toxic-Shock SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedizinische Forschungs gmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
- Investigators
- Martha M Eibl, MD, Study director, Biomedizinische ForschungsgmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971670
- Sponsor's protocol ID
- BioMed0713 B
- Status last verified
- May 2017
- First submitted
- 21 Nov 2016
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amendment of Phase 1 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT02971670
- Acronym / sponsor ID
- BioMed0713 B
- Conditions
- Toxic-Shock Syndrome, Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Biomedizinische Forschungs gmbHIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 8 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 | Experimental | Biological: rTSST-1 Variant Candidate VaccineTreatment: rTSST-1 Variant Candidate Vaccine 3 µg |
| Dose Group 2 | Experimental | Biological: rTSST-1 Variant Candidate VaccineTreatment: rTSST-1 Variant Candidate Vaccine 10 µg |
| Dose Group 3 | Experimental | Biological: rTSST-1 Variant Candidate VaccineTreatment: rTSST-1 Variant Candidate Vaccine 30 µg |
| Dose Group 0 | Placebo comparator | Biological: rTSST-1 Variant Candidate VaccineControl: Al(OH)3 Adjuvant |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male and female
- 18 - 64 years
- written informed consent
- physical exam: no abnormal findings unless considered irrelevant by the investigator
- uneventful medical history
Key exclusion criteria (3 listed)
- pregnancy
- positive virology markers at first screening
- signs and symptoms of relevant autoimmunity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTSST-1 Variant Candidate VaccineImmunization 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. | Biological | Dose Group 0, Dose Group 1, Dose Group 2, Dose Group 3 |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety
Time frame: through 6 months
Clinical observation and clinical laboratory values
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.
1 secondary outcome
Boosterability of BioMed rTSST-1 Variant Vaccine
Time frame: through 6 months after third immunization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha M Eibl, MD study director
Biomedizinische ForschungsgmbH
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rTSST-1 Variant Candidate Vaccine in people with Toxic-Shock Syndrome and Sepsis, run by Biomedizinische Forschungs gmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety (time frame: through 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.