Trial Outcomes & Findings for Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial (NCT NCT02971670)
NCT ID: NCT02971670
Last Updated: 2017-06-09
Results Overview
Clinical observation and clinical laboratory values
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
through 6 months
Results posted on
2017-06-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
2
|
5
|
3
|
|
Overall Study
COMPLETED
|
9
|
1
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
1
|
2
|
Baseline Characteristics
Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial
Baseline characteristics by cohort
| Measure |
Dose Group 1
n=13 Participants
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.
|
Dose Group 2
n=2 Participants
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.
|
Dose Group 3
n=5 Participants
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.
|
Dose Group 0
n=3 Participants
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.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
45 years
STANDARD_DEVIATION 18.4 • n=4 Participants
|
28.6 years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
31.3 years
STANDARD_DEVIATION 10.7 • n=483 Participants
|
35.9 years
STANDARD_DEVIATION 10.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Region of Enrollment
Austria
|
13 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: through 6 monthsPopulation: Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.
Clinical observation and clinical laboratory values
Outcome measures
| Measure |
Dose Group 1
n=9 Participants
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.
|
Dose Group 2
n=1 Participants
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.
|
Dose Group 3
n=4 Participants
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.
|
Dose Group 0
n=1 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety
|
7 participants
|
1 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 6-15 months after last immunization of Phase IELISA 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.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
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.
|
Dose Group 2
n=2 Participants
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.
|
Dose Group 3
n=5 Participants
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.
|
Dose Group 0
n=3 Participants
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.
|
|---|---|---|---|---|
|
Persistence of TSST-1 Antibodies
|
9 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through 6 months after third immunizationPopulation: Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.
ELISA IgG against rTSST-1. Boosterability was defined as an increase in TSST-1 Ab titer as compared to antibody titers after second vaccination.
Outcome measures
| Measure |
Dose Group 1
n=9 Participants
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.
|
Dose Group 2
n=1 Participants
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.
|
Dose Group 3
n=4 Participants
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.
|
Dose Group 0
n=1 Participants
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.
|
|---|---|---|---|---|
|
Boosterability of BioMed rTSST-1 Variant Vaccine
|
8 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Dose Group 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Group 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Group 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Group 0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Group 1
n=9 participants at risk
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.
|
Dose Group 2
n=1 participants at risk
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.
|
Dose Group 3
n=4 participants at risk
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.
|
Dose Group 0
n=1 participants at risk
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.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Non-drug-related Hospitalization
|
11.1%
1/9 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/1
|
Other adverse events
| Measure |
Dose Group 1
n=9 participants at risk
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.
|
Dose Group 2
n=1 participants at risk
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.
|
Dose Group 3
n=4 participants at risk
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.
|
Dose Group 0
n=1 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Mild to moderate reactions
|
77.8%
7/9
|
100.0%
1/1
|
25.0%
1/4
|
0.00%
0/1
|
Additional Information
Dr. Martha M. Eibl
Biomedizinische Forschungsgesellschaft mbH
Phone: +43-1-4081091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place