Study: NCT02340338

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rTSST-1 Variant Candidate Vaccine
Description: 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.