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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 | Experimental | Treatment: rTSST-1 Variant Candidate Vaccine 3 µg |
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| Dose Group 2 | Experimental | Treatment: rTSST-1 Variant Candidate Vaccine 10 µg |
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| Dose Group 3 | Experimental | Treatment: rTSST-1 Variant Candidate Vaccine 30 µg |
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| Dose Group 0 | Placebo Comparator | Control: Al(OH)3 Adjuvant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through 6 months after third immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha M Eibl, MD | Biomedizinische ForschungsgmbH | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Group 1 | Treatment: rTSST-1 Variant Candidate Vaccine 3 µg rTSST-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. |
| FG001 | Dose Group 2 | Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-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. |
| FG002 | Dose Group 3 | Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-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. |
| FG003 | Dose Group 0 | Control: Al(OH)3 Adjuvant rTSST-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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Group 1 | Treatment: rTSST-1 Variant Candidate Vaccine 3 µg rTSST-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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety | Clinical observation and clinical laboratory values | Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population. | Posted | Number | participants | through 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Group 1 | Treatment: rTSST-1 Variant Candidate Vaccine 3 µg rTSST-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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-drug-related Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Hospitalization became necessary subsequently to a radius fracture to surgically remove osteosynthesis material from the left arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild to moderate reactions | General disorders | Systematic Assessment | All other adverse events were mild to moderate, with symptoms as in Phase I (NCT02340338), and all were classified as not clinically relevant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martha M. Eibl | Biomedizinische Forschungsgesellschaft mbH | +43-1-4081091 | martha.eibl@meduniwien.ac.at |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| BG001 | Dose Group 2 | Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-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. |
| BG002 | Dose Group 3 | Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-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. |
| BG003 | Dose Group 0 | Control: Al(OH)3 Adjuvant rTSST-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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-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. |
| OG002 | Dose Group 3 | Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-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. |
| OG003 | Dose Group 0 | Control: Al(OH)3 Adjuvant rTSST-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. |
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| Primary | 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. | Posted | Count of Participants | Participants | 6-15 months after last immunization of Phase I |
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| Secondary | 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. | Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population. | Posted | Count of Participants | Participants | through 6 months after third immunization |
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| 1 |
| 9 |
| 7 |
| 9 |
| EG001 | Dose Group 2 | Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-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. | 0 | 1 | 1 | 1 |
| EG002 | Dose Group 3 | Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-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. | 0 | 4 | 1 | 4 |
| EG003 | Dose Group 0 | Control: Al(OH)3 Adjuvant rTSST-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. | 0 | 1 | 0 | 1 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |