Study: NCT01643941

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA4Ag vaccine low dose
Description: Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood draw
Description: Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab sample
Description: Colonization swabs will be collected from all subjects at various timepoints.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA4Ag vaccine mid dose
Description: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood draw
Description: Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab sample
Description: Colonization swabs will be collected from all subjects at various timepoints.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA4Ag vaccine high dose
Description: Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood draw
Description: Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab sample
Description: Colonization swabs will be collected from all subjects at various timepoints.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SA3Ag vaccine
Description: Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Blood sample
Description: Blood for immunogenicity will be collected from all subjects at various timepoints.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Colonization swab sample
Description: Colonization swabs will be collected from all subjects at various timepoints.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Blood draw
Description: Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Colonization swab samples
Description: Colonization swabs will be collected from all subjects at various timepoints.