Trial Outcomes & Findings for Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial (NCT NCT01011335)
NCT ID: NCT01011335
Last Updated: 2023-03-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2023-03-07
Participant Flow
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.
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.
Participant milestones
| Measure |
Monovalent rAT 10 ug Dose
Intramuscular; Monovalent rAT : 10 μg; single timepoint
|
Monovalent rAT 25 ug Dose
Intramuscular; Monovalent rAT : 25 μg; single timepoint
|
Monovalent rAT 50 ug Dose
Intramuscular; Monovalent rAT : 50 μg; single timepoint
|
Monovalent rAT 100 ug Dose
Intramuscular; Monovalent rAT : 100 μg; single timepoint
|
Monovalent rLukS 10 ug Dose
Intramuscular; Monovalent rLukS-PV : 10 μg; single timepoint
|
Monovalent rLukS 25 ug Dose
Intramuscular; Monovalent rLukS-PV : 25 μg; single timepoint
|
Monovalent rLukS 50 ug Dose
Intramuscular; Monovalent rLukS-PV : 50 μg; single timepoint
|
Monovalent rLukS 100 ug Dose
Intramuscular; Monovalent rLukS-PV : 100 μg; single timepoint
|
Bivalent rAT/rLukS 10 ug Dose
Intramuscular; Bivalent rAT/rLukS : 10 μg; single timepoint
|
Bivalent rAT/rLukS 25 ug Dose
Intramuscular; Bivalent rAT/rLukS : 25 μg; single timepoint
|
Bivalent rAT/rLukS 50 ug Dose
Intramuscular; Bivalent rAT/rLukS : 50 μg; single timepoint
|
Alum Placebo
Intramuscular; Alum placebo : 10, 25, 50, 100 μg; single timepoint
|
Normal Saline Placebo
Intramuscular; Saline Placebo : 10, 25, 50, 100 μg; single timepoint
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
12
|
12
|
13
|
12
|
12
|
12
|
12
|
12
|
12
|
22
|
22
|
|
Overall Study
COMPLETED
|
10
|
11
|
11
|
10
|
12
|
11
|
9
|
10
|
10
|
12
|
6
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
1
|
1
|
3
|
2
|
2
|
0
|
6
|
1
|
3
|
Reasons for withdrawal
| Measure |
Monovalent rAT 10 ug Dose
Intramuscular; Monovalent rAT : 10 μg; single timepoint
|
Monovalent rAT 25 ug Dose
Intramuscular; Monovalent rAT : 25 μg; single timepoint
|
Monovalent rAT 50 ug Dose
Intramuscular; Monovalent rAT : 50 μg; single timepoint
|
Monovalent rAT 100 ug Dose
Intramuscular; Monovalent rAT : 100 μg; single timepoint
|
Monovalent rLukS 10 ug Dose
Intramuscular; Monovalent rLukS-PV : 10 μg; single timepoint
|
Monovalent rLukS 25 ug Dose
Intramuscular; Monovalent rLukS-PV : 25 μg; single timepoint
|
Monovalent rLukS 50 ug Dose
Intramuscular; Monovalent rLukS-PV : 50 μg; single timepoint
|
Monovalent rLukS 100 ug Dose
Intramuscular; Monovalent rLukS-PV : 100 μg; single timepoint
|
Bivalent rAT/rLukS 10 ug Dose
Intramuscular; Bivalent rAT/rLukS : 10 μg; single timepoint
|
Bivalent rAT/rLukS 25 ug Dose
Intramuscular; Bivalent rAT/rLukS : 25 μg; single timepoint
|
Bivalent rAT/rLukS 50 ug Dose
Intramuscular; Bivalent rAT/rLukS : 50 μg; single timepoint
|
Alum Placebo
Intramuscular; Alum placebo : 10, 25, 50, 100 μg; single timepoint
|
Normal Saline Placebo
Intramuscular; Saline Placebo : 10, 25, 50, 100 μg; single timepoint
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
2
|
1
|
0
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Moved/deployed or no booster
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
1
|
Baseline Characteristics
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
Baseline characteristics by cohort
| Measure |
Monovalent rAT Doses
n=47 Participants
Monovalent rAT : 10, 25, 50 or 100 μg
|
Monovalent rLukS-PV Doses
n=49 Participants
Monovalent rLukS-PV : 10, 25, 50 or 100 μg
|
Bivalent rAT/rLukS-PV Doses
n=36 Participants
Bivalent rLukS-PV / rAT : 10, 25 or 50 μg
|
Placebo Doses
n=44 Participants
Saline placebo or alum placebo
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
31.1 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
32.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
32.1 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=5 Participants
|
36 participants
n=7 Participants
|
28 participants
n=5 Participants
|
29 participants
n=4 Participants
|
132 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
All Other
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
14 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsAdverse 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
Outcome measures
| Measure |
Monovalent rAT Doses
n=47 Participants
Monovalent rAT 10µg, 25µg, 50µg, 100µg
|
Monovalent rLukS Doses
n=49 Participants
Monovalent rLukS 10µg, 25µg, 50µg, 100µg
|
Bivalent rAT/rLukS Doses
n=36 Participants
rAT/rLukS 10µg, 25µg, 50µg
|
Placebo Doses
n=44 Participants
Alum placebo and Saline placebo
|
rAT/rLukS 10 µg (for rAT)
|
rAT/rLukS 25 µg (for rAT)
|
rAT/rLukS 50 µg (for rAT)
|
Alum Placebo (for rAT)
|
Saline Placebo (for rAT)
|
rLukS 10 µg
|
rLukS 25 µg
|
rLukS 50 µg
|
rLukS 100 µg
|
rAT/rLukS 10 µg (for rLukS)
|
rAT/rLukS 25 µg (for rLukS)
|
rAT/rLukS 50 µg (for rLukS)
|
Alum Placebo (for rLukS)
|
Normal Saline Placebo (for rLukS)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports
Adverse Events
|
37 events
|
40 events
|
28 events
|
36 events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
41 events
|
29 events
|
24 events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsImmunogenicity 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.
Outcome measures
| Measure |
Monovalent rAT Doses
n=11 Participants
Monovalent rAT 10µg, 25µg, 50µg, 100µg
|
Monovalent rLukS Doses
n=11 Participants
Monovalent rLukS 10µg, 25µg, 50µg, 100µg
|
Bivalent rAT/rLukS Doses
n=12 Participants
rAT/rLukS 10µg, 25µg, 50µg
|
Placebo Doses
n=9 Participants
Alum placebo and Saline placebo
|
rAT/rLukS 10 µg (for rAT)
n=10 Participants
|
rAT/rLukS 25 µg (for rAT)
n=11 Participants
|
rAT/rLukS 50 µg (for rAT)
n=12 Participants
|
Alum Placebo (for rAT)
n=21 Participants
|
Saline Placebo (for rAT)
n=20 Participants
|
rLukS 10 µg
n=11 Participants
|
rLukS 25 µg
n=11 Participants
|
rLukS 50 µg
n=12 Participants
|
rLukS 100 µg
n=11 Participants
|
rAT/rLukS 10 µg (for rLukS)
n=10 Participants
|
rAT/rLukS 25 µg (for rLukS)
n=11 Participants
|
rAT/rLukS 50 µg (for rLukS)
n=12 Participants
|
Alum Placebo (for rLukS)
n=21 Participants
|
Normal Saline Placebo (for rLukS)
n=20 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Day 14
|
47.6 μg/mL
Interval 29.4 to 77.0
|
157 μg/mL
Interval 110.9 to 220.9
|
356 μg/mL
Interval 173.8 to 731.1
|
261 μg/mL
Interval 108.9 to 625.4
|
51.1 μg/mL
Interval 27.9 to 93.7
|
116 μg/mL
Interval 64.4 to 207.4
|
213 μg/mL
Interval 141.2 to 320.3
|
20.9 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.46
|
20.5 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.27
|
35.7 μg/mL
Interval 14.11 to 90.4
|
133 μg/mL
Interval 63.16 to 278.5
|
91.7 μg/mL
Interval 37.72 to 223.0
|
67.2 μg/mL
Interval 27.82 to 162.4
|
29.0 μg/mL
Interval 14.16 to 59.39
|
60.2 μg/mL
Interval 22.53 to 161.1
|
108 μg/mL
Interval 65.39 to 179.1
|
15.8 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.71
|
21.5 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.53
|
|
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Day 84
|
57.8 μg/mL
Interval 34.5 to 96.9
|
159 μg/mL
Interval 119.5 to 212.2
|
313 μg/mL
Interval 176.9 to 553.5
|
223 μg/mL
Interval 133.6 to 372.5
|
46.8 μg/mL
Interval 26.4 to 82.8
|
111 μg/mL
Interval 70.5 to 176.1
|
167 μg/mL
Interval 96.9 to 289.2
|
18.8 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.46
|
19.6 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.13
|
39.6 μg/mL
Interval 16.93 to 92.81
|
128 μg/mL
Interval 61.02 to 267.1
|
85.0 μg/mL
Interval 35.91 to 201.5
|
68.6 μg/mL
Interval 29.02 to 162.0
|
29.4 μg/mL
Interval 14.73 to 58.66
|
59.2 μg/mL
Interval 25.66 to 136.6
|
82.5 μg/mL
Interval 45.39 to 149.8
|
14.7 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.71
|
24.6 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.95
|
|
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Day 98
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
203 μg/mL
95% confidence Intervals not available for this group at Day 98 due to insufficient number of participants with data. Standard deviations were calculated. SD=2.2
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
93.3 μg/mL
95% confidence Intervals not available for this group at Day 98 due to insufficient number of participants with data. Standard deviations were calculated. SD=2.48
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
|
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Day 112
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
116 μg/mL
95% confidence Intervals not available for this group at Day 112 due to insufficient number of participants with data. Standard deviations were calculated. SD=6.27
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
57.6 μg/mL
95% confidence Intervals not available for this group at Day 112 due to insufficient number of participants with data. Standard deviations were calculated. SD=6.09
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
NA μg/mL
Arm did not receive booster and were not evaluated at Days 98 and 112.
|
|
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Day 0
|
27.9 μg/mL
Interval 18.7 to 41.7
|
20.7 μg/mL
Interval 11.3 to 37.9
|
16.0 μg/mL
Interval 9.4 to 27.3
|
25.4 μg/mL
Interval 14.9 to 43.4
|
20.9 μg/mL
Interval 12.0 to 36.5
|
32.3 μg/mL
Interval 19.2 to 54.5
|
17.0 μg/mL
Interval 11.7 to 24.8
|
18.5 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.36
|
20.9 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.17
|
12.1 μg/mL
Interval 6.81 to 21.48
|
13.2 μg/mL
Interval 6.68 to 26.06
|
13.1 μg/mL
Interval 7.49 to 22.91
|
9.0 μg/mL
Interval 4.33 to 18.74
|
10.4 μg/mL
Interval 6.66 to 16.17
|
16.8 μg/mL
Interval 8.19 to 34.23
|
17.7 μg/mL
Interval 11.14 to 28.02
|
16.0 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.71
|
22.3 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.41
|
|
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Day 28
|
51.7 μg/mL
Interval 30.9 to 86.4
|
185 μg/mL
Interval 141.6 to 242.3
|
338 μg/mL
Interval 172.8 to 659.4
|
232 μg/mL
Interval 92.0 to 586.9
|
50.2 μg/mL
Interval 28.4 to 88.8
|
129 μg/mL
Interval 77.9 to 213.7
|
223 μg/mL
Interval 145.2 to 342.8
|
19.4 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.43
|
19.5 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=2.32
|
39.8 μg/mL
Interval 15.53 to 101.8
|
166 μg/mL
Interval 78.57 to 352.6
|
103 μg/mL
Interval 43.69 to 244.0
|
81.7 μg/mL
Interval 34.2 to 195.1
|
31.2 μg/mL
Interval 15.13 to 64.34
|
68.1 μg/mL
Interval 27.19 to 170.5
|
108 μg/mL
Interval 61.93 to 187.1
|
14.8 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.91
|
20.7 μg/mL
95% confidence Intervals not available for this group due to insufficient number of participants with data. Standard deviations were calculated. SD=3.54
|
Adverse Events
Monovalent rAT 10µg Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Monovalent rAT 25µg Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Monovalent rAT 50µg Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Monovalent rAT 100µg Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Monovalent rLukS 10µg Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Monovalent rLukS 25µg Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Monovalent rLukS 50µg Dose
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Monovalent rLukS 100µg Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Bivalent rAT/rLukS 10µg Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Bivalent rAT/rLukS 25µg Dose
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Bivalent rAT/rLukS 50µg Dose
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Alum Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Normal Saline Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monovalent rAT 10µg Dose
n=11 participants at risk
|
Monovalent rAT 25µg Dose
n=12 participants at risk
|
Monovalent rAT 50µg Dose
n=12 participants at risk
|
Monovalent rAT 100µg Dose
n=12 participants at risk
|
Monovalent rLukS 10µg Dose
n=13 participants at risk
|
Monovalent rLukS 25µg Dose
n=12 participants at risk
|
Monovalent rLukS 50µg Dose
n=12 participants at risk
|
Monovalent rLukS 100µg Dose
n=12 participants at risk
|
Bivalent rAT/rLukS 10µg Dose
n=12 participants at risk
|
Bivalent rAT/rLukS 25µg Dose
n=12 participants at risk
|
Bivalent rAT/rLukS 50µg Dose
n=12 participants at risk
|
Alum Placebo
n=22 participants at risk
|
Normal Saline Placebo
n=22 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Alcoholism
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Nervous system disorders
Astrocytoma Malignant
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/22
|
4.5%
1/22
|
|
Cardiac disorders
Non-cardiac Chest Pain
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/22
|
0.00%
0/22
|
Other adverse events
| Measure |
Monovalent rAT 10µg Dose
n=11 participants at risk
|
Monovalent rAT 25µg Dose
n=12 participants at risk
|
Monovalent rAT 50µg Dose
n=12 participants at risk
|
Monovalent rAT 100µg Dose
n=12 participants at risk
|
Monovalent rLukS 10µg Dose
n=13 participants at risk
|
Monovalent rLukS 25µg Dose
n=12 participants at risk
|
Monovalent rLukS 50µg Dose
n=12 participants at risk
|
Monovalent rLukS 100µg Dose
n=12 participants at risk
|
Bivalent rAT/rLukS 10µg Dose
n=12 participants at risk
|
Bivalent rAT/rLukS 25µg Dose
n=12 participants at risk
|
Bivalent rAT/rLukS 50µg Dose
n=12 participants at risk
|
Alum Placebo
n=22 participants at risk
|
Normal Saline Placebo
n=22 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemoglobin decreased
|
27.3%
3/11
|
8.3%
1/12
|
58.3%
7/12
|
75.0%
9/12
|
7.7%
1/13
|
8.3%
1/12
|
25.0%
3/12
|
25.0%
3/12
|
25.0%
3/12
|
16.7%
2/12
|
16.7%
2/12
|
13.6%
3/22
|
27.3%
6/22
|
|
Blood and lymphatic system disorders
Blood glucose increased
|
9.1%
1/11
|
16.7%
2/12
|
25.0%
3/12
|
58.3%
7/12
|
15.4%
2/13
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
16.7%
2/12
|
0.00%
0/12
|
8.3%
1/12
|
13.6%
3/22
|
18.2%
4/22
|
|
Blood and lymphatic system disorders
ALT increased
|
18.2%
2/11
|
8.3%
1/12
|
25.0%
3/12
|
25.0%
3/12
|
15.4%
2/13
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
16.7%
2/12
|
8.3%
1/12
|
13.6%
3/22
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Blood glucose decreased
|
0.00%
0/11
|
16.7%
2/12
|
8.3%
1/12
|
33.3%
4/12
|
15.4%
2/13
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
9.1%
2/22
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Haemoglobin abnormal
|
9.1%
1/11
|
0.00%
0/12
|
8.3%
1/12
|
25.0%
3/12
|
0.00%
0/13
|
16.7%
2/12
|
33.3%
4/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
9.1%
2/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
AST increased
|
9.1%
1/11
|
0.00%
0/12
|
41.7%
5/12
|
16.7%
2/12
|
7.7%
1/13
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
33.3%
4/12
|
8.3%
1/12
|
4.5%
1/22
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11
|
0.00%
0/12
|
16.7%
2/12
|
33.3%
4/12
|
7.7%
1/13
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
8.3%
1/12
|
9.1%
2/22
|
9.1%
2/22
|
|
Renal and urinary disorders
Blood urea increased
|
9.1%
1/11
|
8.3%
1/12
|
16.7%
2/12
|
16.7%
2/12
|
15.4%
2/13
|
16.7%
2/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
9.1%
2/22
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Blood LDH increased
|
9.1%
1/11
|
8.3%
1/12
|
25.0%
3/12
|
16.7%
2/12
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
16.7%
2/12
|
0.00%
0/12
|
4.5%
1/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
WBC count increased
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
41.7%
5/12
|
7.7%
1/13
|
8.3%
1/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
9.1%
2/22
|
13.6%
3/22
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/11
|
8.3%
1/12
|
8.3%
1/12
|
25.0%
3/12
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
4.5%
1/22
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
9.1%
1/11
|
8.3%
1/12
|
25.0%
3/12
|
8.3%
1/12
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Hypoglycaemia
|
9.1%
1/11
|
8.3%
1/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/22
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
16.7%
2/12
|
7.7%
1/13
|
8.3%
1/12
|
16.7%
2/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
4.5%
1/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
16.7%
2/12
|
0.00%
0/13
|
8.3%
1/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
4.5%
1/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Blood sodium increased
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/12
|
25.0%
3/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
9.1%
2/22
|
4.5%
1/22
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/11
|
8.3%
1/12
|
8.3%
1/12
|
16.7%
2/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
9.1%
2/22
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Hyperglycaemia
|
0.00%
0/11
|
0.00%
0/12
|
16.7%
2/12
|
8.3%
1/12
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
16.7%
2/12
|
4.5%
1/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/11
|
8.3%
1/12
|
16.7%
2/12
|
0.00%
0/12
|
7.7%
1/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
16.7%
2/12
|
0.00%
0/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11
|
0.00%
0/12
|
25.0%
3/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
16.7%
2/12
|
8.3%
1/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11
|
8.3%
1/12
|
16.7%
2/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Renal and urinary disorders
Protein urine present
|
0.00%
0/11
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12
|
16.7%
2/12
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
16.7%
2/12
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Injection site swelling
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
25.0%
3/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12
|
8.3%
1/12
|
0.00%
0/22
|
0.00%
0/22
|
Additional Information
David Tribble, MD, DrPH
Uniformed Services University of the Health Sciences
Phone: 301-816-8404
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place