Trial Outcomes & Findings for Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults (NCT NCT02814708)
NCT ID: NCT02814708
Last Updated: 2022-01-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
12 months and 18 months follow up
Results posted on
2022-01-04
Participant Flow
Participant milestones
| Measure |
Dose Group 1
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 2
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 3
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 4
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 5
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 6
rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 7
Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
17
|
19
|
20
|
17
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
0
|
3
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Dose Group 1
n=20 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 2
n=20 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 3
n=20 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 4
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 5
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 6
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 7
n=20 Participants
Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
140 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
31.2 years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
36.6 years
STANDARD_DEVIATION 11.8 • n=10 Participants
|
34.2 years
STANDARD_DEVIATION 12.5 • n=115 Participants
|
31.9 years
STANDARD_DEVIATION 11.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
49 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
91 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
138 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Austria
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
20 participants
n=21 Participants
|
20 participants
n=10 Participants
|
20 participants
n=115 Participants
|
140 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 12 months and 18 months follow upPopulation: any suspected related systemic AE
Outcome measures
| Measure |
Dose Group 1
n=20 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 2
n=20 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 3
n=20 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 4
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 5
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 6
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 7
n=20 Participants
Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
|---|---|---|---|---|---|---|---|
|
Number of Participants (Percentage) With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
|
9 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 months and 18 months follow upPopulation: per protocol population included in calculation analysed over time by treatment
Fold increase of antibody titer against rTSST-1 ELISA from prevaccination titer. Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer. Comparison with placebo comparator recipients.
Outcome measures
| Measure |
Dose Group 1
n=18 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 2
n=17 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 3
n=19 Participants
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 4
n=20 Participants
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 5
n=17 Participants
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 6
n=16 Participants
rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 7
n=19 Participants
Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a Fold Increase of ELISA IgG Against rTSST-1
12 months
|
13 Participants
|
15 Participants
|
17 Participants
|
17 Participants
|
13 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants With a Fold Increase of ELISA IgG Against rTSST-1
18 months
|
10 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
12 Participants
|
12 Participants
|
0 Participants
|
Adverse Events
Dose Group 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Dose Group 2
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Dose Group 3
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Dose Group 4
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Dose Group 5
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Dose Group 6
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Dose Group 7
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Group 1
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 2
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 3
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 4
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 5
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 6
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 7
n=20 participants at risk
Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
anaphylactic reaction
|
0.00%
0/20 • 27 months
|
0.00%
0/20 • 27 months
|
0.00%
0/20 • 27 months
|
0.00%
0/20 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
0.00%
0/20 • 27 months
|
0.00%
0/20 • 27 months
|
Other adverse events
| Measure |
Dose Group 1
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 2
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 3
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 4
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 5
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 6
n=20 participants at risk
rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
Dose Group 7
n=20 participants at risk
Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3
rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer .
|
|---|---|---|---|---|---|---|---|
|
General disorders
mild to moderate AE
|
65.0%
13/20 • Number of events 39 • 27 months
|
80.0%
16/20 • Number of events 29 • 27 months
|
70.0%
14/20 • Number of events 26 • 27 months
|
85.0%
17/20 • Number of events 53 • 27 months
|
80.0%
16/20 • Number of events 39 • 27 months
|
95.0%
19/20 • Number of events 40 • 27 months
|
70.0%
14/20 • Number of events 50 • 27 months
|
|
Nervous system disorders
Nervos system disorders
|
35.0%
7/20 • Number of events 25 • 27 months
|
50.0%
10/20 • Number of events 26 • 27 months
|
45.0%
9/20 • Number of events 29 • 27 months
|
75.0%
15/20 • Number of events 81 • 27 months
|
55.0%
11/20 • Number of events 30 • 27 months
|
50.0%
10/20 • Number of events 21 • 27 months
|
50.0%
10/20 • Number of events 42 • 27 months
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Number of events 24 • 27 months
|
45.0%
9/20 • Number of events 25 • 27 months
|
40.0%
8/20 • Number of events 27 • 27 months
|
65.0%
13/20 • Number of events 75 • 27 months
|
55.0%
11/20 • Number of events 30 • 27 months
|
50.0%
10/20 • Number of events 21 • 27 months
|
45.0%
9/20 • Number of events 40 • 27 months
|
|
General disorders
General disorders and administration site conditions
|
40.0%
8/20 • Number of events 23 • 27 months
|
55.0%
11/20 • Number of events 18 • 27 months
|
40.0%
8/20 • Number of events 15 • 27 months
|
65.0%
13/20 • Number of events 33 • 27 months
|
45.0%
9/20 • Number of events 23 • 27 months
|
50.0%
10/20 • Number of events 21 • 27 months
|
45.0%
9/20 • Number of events 24 • 27 months
|
|
General disorders
Fatigue
|
30.0%
6/20 • Number of events 18 • 27 months
|
35.0%
7/20 • Number of events 10 • 27 months
|
20.0%
4/20 • Number of events 8 • 27 months
|
40.0%
8/20 • Number of events 15 • 27 months
|
25.0%
5/20 • Number of events 9 • 27 months
|
40.0%
8/20 • Number of events 10 • 27 months
|
40.0%
8/20 • Number of events 16 • 27 months
|
|
General disorders
Influenza-like illness
|
10.0%
2/20 • Number of events 4 • 27 months
|
30.0%
6/20 • Number of events 7 • 27 months
|
15.0%
3/20 • Number of events 6 • 27 months
|
40.0%
8/20 • Number of events 12 • 27 months
|
30.0%
6/20 • Number of events 12 • 27 months
|
40.0%
8/20 • Number of events 9 • 27 months
|
20.0%
4/20 • Number of events 6 • 27 months
|
|
Infections and infestations
Infections and infestations
|
60.0%
12/20 • Number of events 19 • 27 months
|
55.0%
11/20 • Number of events 25 • 27 months
|
60.0%
12/20 • Number of events 22 • 27 months
|
50.0%
10/20 • Number of events 18 • 27 months
|
45.0%
9/20 • Number of events 13 • 27 months
|
45.0%
9/20 • Number of events 20 • 27 months
|
50.0%
10/20 • Number of events 21 • 27 months
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
5/20 • Number of events 7 • 27 months
|
50.0%
10/20 • Number of events 18 • 27 months
|
30.0%
6/20 • Number of events 9 • 27 months
|
25.0%
5/20 • Number of events 6 • 27 months
|
35.0%
7/20 • Number of events 10 • 27 months
|
45.0%
9/20 • Number of events 16 • 27 months
|
30.0%
6/20 • Number of events 10 • 27 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
35.0%
7/20 • Number of events 9 • 27 months
|
40.0%
8/20 • Number of events 10 • 27 months
|
25.0%
5/20 • Number of events 7 • 27 months
|
55.0%
11/20 • Number of events 17 • 27 months
|
60.0%
12/20 • Number of events 19 • 27 months
|
40.0%
8/20 • Number of events 16 • 27 months
|
30.0%
6/20 • Number of events 9 • 27 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
30.0%
6/20 • Number of events 6 • 27 months
|
35.0%
7/20 • Number of events 13 • 27 months
|
25.0%
5/20 • Number of events 10 • 27 months
|
40.0%
8/20 • Number of events 18 • 27 months
|
10.0%
2/20 • Number of events 2 • 27 months
|
25.0%
5/20 • Number of events 9 • 27 months
|
20.0%
4/20 • Number of events 8 • 27 months
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • 27 months
|
25.0%
5/20 • Number of events 6 • 27 months
|
20.0%
4/20 • Number of events 6 • 27 months
|
25.0%
5/20 • Number of events 10 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
15.0%
3/20 • Number of events 4 • 27 months
|
15.0%
3/20 • Number of events 4 • 27 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
20.0%
4/20 • Number of events 4 • 27 months
|
15.0%
3/20 • Number of events 4 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
20.0%
4/20 • Number of events 4 • 27 months
|
30.0%
6/20 • Number of events 8 • 27 months
|
15.0%
3/20 • Number of events 5 • 27 months
|
20.0%
4/20 • Number of events 4 • 27 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
10.0%
2/20 • Number of events 2 • 27 months
|
15.0%
3/20 • Number of events 3 • 27 months
|
20.0%
4/20 • Number of events 4 • 27 months
|
20.0%
4/20 • Number of events 5 • 27 months
|
30.0%
6/20 • Number of events 11 • 27 months
|
15.0%
3/20 • Number of events 3 • 27 months
|
10.0%
2/20 • Number of events 2 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
10.0%
2/20 • Number of events 2 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
25.0%
5/20 • Number of events 6 • 27 months
|
20.0%
4/20 • Number of events 5 • 27 months
|
25.0%
5/20 • Number of events 5 • 27 months
|
0.00%
0/20 • 27 months
|
5.0%
1/20 • Number of events 2 • 27 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1 • 27 months
|
0.00%
0/20 • 27 months
|
20.0%
4/20 • Number of events 4 • 27 months
|
15.0%
3/20 • Number of events 3 • 27 months
|
10.0%
2/20 • Number of events 2 • 27 months
|
0.00%
0/20 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
5.0%
1/20 • Number of events 1 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
10.0%
2/20 • Number of events 3 • 27 months
|
25.0%
5/20 • Number of events 11 • 27 months
|
0.00%
0/20 • 27 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
1/20 • Number of events 1 • 27 months
|
0.00%
0/20 • 27 months
|
0.00%
0/20 • 27 months
|
0.00%
0/20 • 27 months
|
5.0%
1/20 • Number of events 2 • 27 months
|
20.0%
4/20 • Number of events 10 • 27 months
|
0.00%
0/20 • 27 months
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/20 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
0.00%
0/20 • 27 months
|
10.0%
2/20 • Number of events 2 • 27 months
|
15.0%
3/20 • Number of events 5 • 27 months
|
0.00%
0/20 • 27 months
|
10.0%
2/20 • Number of events 2 • 27 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • Number of events 3 • 27 months
|
20.0%
4/20 • Number of events 5 • 27 months
|
20.0%
4/20 • Number of events 4 • 27 months
|
30.0%
6/20 • Number of events 6 • 27 months
|
30.0%
6/20 • Number of events 9 • 27 months
|
25.0%
5/20 • Number of events 9 • 27 months
|
25.0%
5/20 • Number of events 8 • 27 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
20.0%
4/20 • Number of events 5 • 27 months
|
5.0%
1/20 • Number of events 1 • 27 months
|
10.0%
2/20 • Number of events 2 • 27 months
|
0.00%
0/20 • 27 months
|
Additional Information
Dr. Martha M. Eibl
Biomedizinische Forschung & Bio-Produkte AG
Phone: +43-1-4081091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place