Trial Outcomes & Findings for rTSST-1 Variant Vaccine Phase 1 First-in-man Trail (NCT NCT02340338)

NCT ID: NCT02340338

Last Updated: 2017-01-31

Results Overview

Clinical observations and clinical laboratory values

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

through day 70

Results posted on

2017-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Group 1 Treatment: rTSST-1 Variant Candidate Vaccine 100 ng rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 2 Treatment: rTSST-1 Variant Candidate Vaccine 300 ng rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 3 Treatment: rTSST-1 Variant Candidate Vaccine 1 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 4 Treatment: rTSST-1 Variant Candidate Vaccine 3 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 5 Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 6 Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 0 Control: Al(OH)3 Adjuvant rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.
Overall Study STARTED	2	2	3	9	9	9	12
Overall Study COMPLETED	2	2	3	9	9	9	12
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

rTSST-1 Variant Vaccine Phase 1 First-in-man Trail

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Group 1 n=2 Participants Treatment: rTSST-1 Variant Candidate Vaccine 100 ng rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 2 n=2 Participants Treatment: rTSST-1 Variant Candidate Vaccine 300 ng rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 3 n=3 Participants Treatment: rTSST-1 Variant Candidate Vaccine 1 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 4 n=9 Participants Treatment: rTSST-1 Variant Candidate Vaccine 3 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 5 n=9 Participants Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 6 n=9 Participants Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 0 n=12 Participants Control: Al(OH)3 Adjuvant rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Total n=46 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	9 Participants n=483 Participants	9 Participants n=36 Participants	9 Participants n=10 Participants	12 Participants n=115 Participants	46 Participants n=40 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants
Age, Continuous	44.0 years STANDARD_DEVIATION 9.9 • n=93 Participants	37.5 years STANDARD_DEVIATION 13.4 • n=4 Participants	36.3 years STANDARD_DEVIATION 5.1 • n=27 Participants	36.2 years STANDARD_DEVIATION 10.9 • n=483 Participants	33.7 years STANDARD_DEVIATION 11.7 • n=36 Participants	27.7 years STANDARD_DEVIATION 7.2 • n=10 Participants	34.4 years STANDARD_DEVIATION 8.5 • n=115 Participants	34.0 years STANDARD_DEVIATION 9.7 • n=40 Participants
Gender Female	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	6 Participants n=36 Participants	7 Participants n=10 Participants	6 Participants n=115 Participants	27 Participants n=40 Participants
Gender Male	2 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants	3 Participants n=36 Participants	2 Participants n=10 Participants	6 Participants n=115 Participants	19 Participants n=40 Participants
Region of Enrollment Austria	2 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants	9 participants n=483 Participants	9 participants n=36 Participants	9 participants n=10 Participants	12 participants n=115 Participants	46 participants n=40 Participants
Safety and Immunogenicity assessment.	2 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants	9 participants n=483 Participants	9 participants n=36 Participants	9 participants n=10 Participants	12 participants n=115 Participants	46 participants n=40 Participants

PRIMARY outcome

Timeframe: through day 70

Clinical observations and clinical laboratory values

Outcome measures

Outcome measures
Measure	Dose Group 1 n=2 Participants Treatment: rTSST-1 Variant Candidate Vaccine 100 ng rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 2 n=2 Participants Treatment: rTSST-1 Variant Candidate Vaccine 300 ng rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 3 n=3 Participants Treatment: rTSST-1 Variant Candidate Vaccine 1 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 4 n=9 Participants Treatment: rTSST-1 Variant Candidate Vaccine 3 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 5 n=9 Participants Treatment: rTSST-1 Variant Candidate Vaccine 10 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 6 n=9 Participants Treatment: rTSST-1 Variant Candidate Vaccine 30 µg rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.	Dose Group 0 n=12 Participants Control: Al(OH)3 Adjuvant rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above. Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 Ab titer . Patients 3 µg or more will be randomized.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	1 participants with any solicited AE	1 participants with any solicited AE	2 participants with any solicited AE	7 participants with any solicited AE	8 participants with any solicited AE	7 participants with any solicited AE	9 participants with any solicited AE

SECONDARY outcome

Timeframe: through day 70

ELISA IgG against rTSST-1