Staphylococcus Aureus
Conditions
Keywords
Staphylococcus aureus, Skin and soft tissue infection, Methicillin-resistant Staphylococcus aureus, Recombinant alpha-toxoid (rAT), Recombinant LukS subunit of Panton-Valentine Leukocidin (rLukS-PV)
Brief summary
This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.
Detailed description
Staphylococcus aureus is a leading cause of skin and soft tissue infections. Antibiotic resistance, such as seen with new community-acquired methicillin-resistant strains, presents a major challenge in treating and preventing these infections. Therefore, a preventative vaccine is considered a potentially better approach. This study assesses the safety and immunogenicity of monovalent and bivalent S. aureus vaccine components. Healthy adult subjects will be randomized to receive 1 dose of monovalent or bivalent toxoid vaccine, or placebo in a dose escalation schedule. Antigen-specific antibody will be measured by ELISA in sera collected for three months after injection. Safety data will be collected as 7 day reactogenicity diaries after each injection, adverse events and Staphylococcus aureus and skin and soft tissue infections will be collected through Day 84, and serious adverse events and chronic illnesses will be collected for the full 6 month study period. To evaluate the possible utility of booster doses, the cohort receiving the highest dose of bivalent antigen will have a 2nd dose administered at Day 84, with a new 7-day reactogenicity diary and sera collected after the 2nd dose. All subjects will be followed up with a 6 month phone call after vaccination or booster. The total subject observation period will be for 24 weeks from Day 0, plus 12 additional weeks for the cohorts that receive a 2nd dose. With a recruitment period of 4 months, the study duration is expected to be approximately 13 months.
Interventions
BIOLOGICALMonovalent rAT
10, 25, 50 or 100 μg
BIOLOGICALMonovalent rLukS-PV
10, 25, 50 or 100 μg
BIOLOGICALBivalent rLukS-PV / rAT
10, 25 or 50 μg
BIOLOGICALPlacebo with adjuvant
Placebo with adjuvant
BIOLOGICALPlacebo
Placebo saline
Sponsors
Nabi Biopharmaceuticals
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males or females, DoD beneficiaries, including active duty members, 18-55 years of age. * Negative urine pregnancy test for female subjects of child bearing potential (negative test within 24 hours prior to investigational product injection) or documented surgical sterility. * Female subjects of child-bearing potential must use an acceptable method of birth control, as determined by the PI. * Willingness to participate in this study as evidenced by written informed consent.
Exclusion criteria
* Prior receipt of S. aureus rAT or rLukS-PV * Known S. aureus infection requiring medical treatment within the 3 months prior to investigational drug product injection * Known active viral or bacterial infection * Seropositivity for HIV infection * Known or suspected abuse of prescribed or illicit drugs, or alcohol in the past year * Use of any new medications (except oral contraceptives, over-the-counter medications, or vitamin supplements) within the 7 days prior to investigational drug product injection * Use of investigational drugs, vaccines, or devices during the study or within the 30 days prior to each dose of investigational drug product injection, or anticipated use of such items during the study * Use of systemic steroids (any dose) or high daily dose inhaled steroids within the last month. Use of low or medium daily dose inhaled, intranasal, or low potency topical steroid creams/ointments is allowed unless such medication was begun within the previous 7 days. * History of a bleeding or coagulation disorder; or use of anti-coagulant medications within 7 days prior to investigational product injection * Actively breastfeeding * Presence of grade I or higher abnormality in laboratory or vital signs parameter at time of screening * Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Up to 6 months | Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary |
| Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Up to 3 months | Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold. |
Countries
United States
Participant flow
Recruitment details
Eligible subjects were recruited from two clinical sites: San Antonio Military Medical Center, San Antonio, TX and Naval Medical Center, Portsmouth, VA between August 2010 and February 2011.
Pre-assignment details
Subjects who consented to the study but who were not randomized were those who either failed screening due to abnormal baseline laboratory results, or who met screening criteria but became ineligible to receive a study injection or were unavailable at the time of injection. Subjects who were unavailable at the time of injection were replaced.
Participants by arm
| Arm | Count |
|---|---|
| Monovalent rAT Doses Monovalent rAT : 10, 25, 50 or 100 μg | 47 |
| Monovalent rLukS-PV Doses Monovalent rLukS-PV : 10, 25, 50 or 100 μg | 49 |
| Bivalent rAT/rLukS-PV Doses Bivalent rLukS-PV / rAT : 10, 25 or 50 μg | 36 |
| Placebo Doses Saline placebo or alum placebo | 44 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 2 | 1 | 0 | 0 | 1 | 2 |
| Overall Study | Moved/deployed or no booster | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Bivalent rAT/rLukS-PV Doses | Monovalent rLukS-PV Doses | Monovalent rAT Doses | Placebo Doses |
|---|---|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 9.3 | 32.0 years STANDARD_DEVIATION 8.6 | 31.1 years STANDARD_DEVIATION 8.6 | 32.5 years STANDARD_DEVIATION 10 | 32.9 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 6 Participants | 6 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 30 Participants | 43 Participants | 38 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized All Other | 14 participants | 1 participants | 6 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Black | 30 participants | 7 participants | 7 participants | 6 participants | 10 participants |
| Race/Ethnicity, Customized White | 132 participants | 28 participants | 36 participants | 39 participants | 29 participants |
| Sex: Female, Male Female | 60 Participants | 15 Participants | 14 Participants | 15 Participants | 16 Participants |
| Sex: Female, Male Male | 116 Participants | 21 Participants | 35 Participants | 32 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 11 | 10 / 12 | 10 / 12 | 9 / 12 | 9 / 13 | 12 / 12 | 9 / 12 | 10 / 12 | 7 / 12 | 8 / 12 | 12 / 12 | 19 / 22 | 16 / 22 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 13 | 0 / 12 | 1 / 12 | 0 / 12 | 0 / 12 | 1 / 12 | 2 / 12 | 0 / 22 | 1 / 22 |
Outcome results
Primary
Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports
Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary
Time frame: Up to 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monovalent rAT Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Adverse Events | 37 events |
| Monovalent rAT Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Local or Systemic Reactogenicity Events | 31 events |
| Monovalent rLukS Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Local or Systemic Reactogenicity Events | 41 events |
| Monovalent rLukS Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Adverse Events | 40 events |
| Bivalent rAT/rLukS Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Local or Systemic Reactogenicity Events | 29 events |
| Bivalent rAT/rLukS Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Adverse Events | 28 events |
| Placebo Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Adverse Events | 36 events |
| Placebo Doses | Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports | Local or Systemic Reactogenicity Events | 24 events |
Primary
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold.
Time frame: Up to 3 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Monovalent rAT Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 57.8 μg/mL |
| Monovalent rAT Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Monovalent rAT Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| Monovalent rAT Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 47.6 μg/mL |
| Monovalent rAT Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 27.9 μg/mL |
| Monovalent rAT Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 51.7 μg/mL |
| Monovalent rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Monovalent rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 185 μg/mL |
| Monovalent rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 159 μg/mL |
| Monovalent rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| Monovalent rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 20.7 μg/mL |
| Monovalent rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 157 μg/mL |
| Bivalent rAT/rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 313 μg/mL |
| Bivalent rAT/rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 16.0 μg/mL |
| Bivalent rAT/rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 338 μg/mL |
| Bivalent rAT/rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Bivalent rAT/rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| Bivalent rAT/rLukS Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 356 μg/mL |
| Placebo Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 232 μg/mL |
| Placebo Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 223 μg/mL |
| Placebo Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Placebo Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 261 μg/mL |
| Placebo Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 25.4 μg/mL |
| Placebo Doses | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rAT/rLukS 10 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rAT/rLukS 10 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 20.9 μg/mL |
| rAT/rLukS 10 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 51.1 μg/mL |
| rAT/rLukS 10 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rAT/rLukS 10 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 50.2 μg/mL |
| rAT/rLukS 10 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 46.8 μg/mL |
| rAT/rLukS 25 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 129 μg/mL |
| rAT/rLukS 25 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rAT/rLukS 25 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 111 μg/mL |
| rAT/rLukS 25 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rAT/rLukS 25 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 116 μg/mL |
| rAT/rLukS 25 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 32.3 μg/mL |
| rAT/rLukS 50 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 223 μg/mL |
| rAT/rLukS 50 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 167 μg/mL |
| rAT/rLukS 50 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 17.0 μg/mL |
| rAT/rLukS 50 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | 203 μg/mL |
| rAT/rLukS 50 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | 116 μg/mL |
| rAT/rLukS 50 µg (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 213 μg/mL |
| Alum Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 18.5 μg/mL |
| Alum Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Alum Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 18.8 μg/mL |
| Alum Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| Alum Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 20.9 μg/mL |
| Alum Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 19.4 μg/mL |
| Saline Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 20.5 μg/mL |
| Saline Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 20.9 μg/mL |
| Saline Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 19.5 μg/mL |
| Saline Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 19.6 μg/mL |
| Saline Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Saline Placebo (for rAT) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rLukS 10 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rLukS 10 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 39.6 μg/mL |
| rLukS 10 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 12.1 μg/mL |
| rLukS 10 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rLukS 10 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 35.7 μg/mL |
| rLukS 10 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 39.8 μg/mL |
| rLukS 25 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 133 μg/mL |
| rLukS 25 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rLukS 25 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 128 μg/mL |
| rLukS 25 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rLukS 25 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 13.2 μg/mL |
| rLukS 25 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 166 μg/mL |
| rLukS 50 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 85.0 μg/mL |
| rLukS 50 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 103 μg/mL |
| rLukS 50 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rLukS 50 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 91.7 μg/mL |
| rLukS 50 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 13.1 μg/mL |
| rLukS 50 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rLukS 100 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rLukS 100 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 9.0 μg/mL |
| rLukS 100 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 67.2 μg/mL |
| rLukS 100 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rLukS 100 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 81.7 μg/mL |
| rLukS 100 µg | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 68.6 μg/mL |
| rAT/rLukS 10 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 10.4 μg/mL |
| rAT/rLukS 10 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 31.2 μg/mL |
| rAT/rLukS 10 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rAT/rLukS 10 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 29.4 μg/mL |
| rAT/rLukS 10 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 29.0 μg/mL |
| rAT/rLukS 10 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rAT/rLukS 25 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| rAT/rLukS 25 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| rAT/rLukS 25 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 16.8 μg/mL |
| rAT/rLukS 25 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 68.1 μg/mL |
| rAT/rLukS 25 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 60.2 μg/mL |
| rAT/rLukS 25 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 59.2 μg/mL |
| rAT/rLukS 50 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 17.7 μg/mL |
| rAT/rLukS 50 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 108 μg/mL |
| rAT/rLukS 50 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | 57.6 μg/mL |
| rAT/rLukS 50 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | 93.3 μg/mL |
| rAT/rLukS 50 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 82.5 μg/mL |
| rAT/rLukS 50 µg (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 108 μg/mL |
| Alum Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 16.0 μg/mL |
| Alum Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| Alum Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 14.8 μg/mL |
| Alum Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 14.7 μg/mL |
| Alum Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 15.8 μg/mL |
| Alum Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Normal Saline Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 0 | 22.3 μg/mL |
| Normal Saline Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 28 | 20.7 μg/mL |
| Normal Saline Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 98 | NA μg/mL |
| Normal Saline Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 112 | NA μg/mL |
| Normal Saline Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 84 | 24.6 μg/mL |
| Normal Saline Placebo (for rLukS) | Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population | Day 14 | 21.5 μg/mL |