← Trials/Trial dossier/NCT01238991
TerminatedPhase 2Results posted
Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Lead sponsor
Asset
ACC-001
Listed sites
11
Recruiting sites
-
Enrollment
53
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•Brain MRI excludes vasogenic edema
Primary endpoints
•Number of Treatment Emergent Adverse Events (AEs) by Severity•Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data•Abnormalities in Neurological Examination
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Secondary ID3134K1-2207Alias Study Number
Org study IDB2571001
NCT IDNCT01238991
Timeline
Milestones
Study first posted2010-11-11estimated
Study start2010-12 (month precision)
Primary completion2013-12actual (month precision)
Study completion2013-12actual (month precision)
Last update posted2014-12-22estimated
Results first posted2014-12-22estimated
Assets
Drug assets
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age52 Years
Maximum age87 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
•Screening brain MRI scan is consistent with the diagnosis of AD.
•MMSE score 10 and above
Exclusion criteria
•Significant neurological diseases other than AD.
•Brain MRI evidence of vasogenic edema during the preceding studies.
•Clinically significant illness.
Endpoints (18)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
6
Other (unclassified)
4
Executive function / language
2
Function / daily living
2
Neuroimaging
2
Safety / tolerability / PK
2
Global cognition
6 endpointsOther/protocol endpoint
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
Time frame:Baseline up to 24 Months
ADAS-Cog
concentration, descriptive
Other/protocol endpoint
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
Time frame:Baseline up to 24 Months
categorical status, descriptive
Other/protocol endpoint
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
Time frame:Baseline up to 24 Months
Mini-Mental State Examination (MMSE)
descriptive
Other_pre_specified/registry result
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
Time frame:Baseline up to 24 Months
ADAS-Cog
concentration, descriptive
Other_pre_specified/registry result
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
Time frame:Baseline up to 24 Months
categorical status, descriptive
Other_pre_specified/registry result
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
Time frame:Baseline up to 24 Months
Mini-Mental State Examination (MMSE)
descriptive
Executive function / language
2 endpointsPrimary/protocol endpoint
Number of Participants With Abnormalities in Neurological Examination
Time frame:Baseline of the preceding studies through 24 months of this study
event count, event
Primary/registry result
Number of Participants With Abnormalities in Neurological Examination
Time frame:Baseline of the preceding studies through 24 months of this study
event count, event
Posted result
| Group | Value (number), Participants | Reported bounds |
|---|---|---|
| 3 μg ACC-001 TreatMental Statusn=7 Participants | 0 | - |
| Speechn=7 Participants | 0 | - |
| Cranial Nerve Functionn=7 Participants | 0 | - |
| Cranial Nerve IIn=7 Participants | 0 | - |
| Sensory Functionn=7 Participants | 0 | - |
| Motor Functionn=7 Participants | 0 | - |
| Coordinationn=7 Participants | 0 | - |
| Gait and Stationn=7 Participants | 0 | - |
| Reflexesn=7 Participants | 0 | - |
| Deep Tendon Reflexesn=7 Participants | 0 | - |
| 3 μg ControlMental Statusn=3 Participants | 0 | - |
| Speechn=3 Participants | 0 | - |
| Cranial Nerve Functionn=3 Participants | 0 | - |
| Cranial Nerve IIn=3 Participants | 0 | - |
| Sensory Functionn=3 Participants | 0 | - |
| Motor Functionn=3 Participants | 0 | - |
| Coordinationn=3 Participants | 0 | - |
| Gait and Stationn=3 Participants | 0 | - |
| Reflexesn=3 Participants | 0 | - |
| Deep Tendon Reflexesn=3 Participants | 0 | - |
| 10 μg ACC-001 TreatMental Statusn=17 Participants | 2 | - |
| Speechn=17 Participants | 1 | - |
| Cranial Nerve Functionn=17 Participants | 0 | - |
| Cranial Nerve IIn=17 Participants | 1 | - |
| Sensory Functionn=17 Participants | 0 | - |
| Motor Functionn=17 Participants | 0 | - |
| Coordinationn=17 Participants | 0 | - |
| Gait and Stationn=17 Participants | 2 | - |
| Reflexesn=17 Participants | 0 | - |
| Deep Tendon Reflexesn=17 Participants | 0 | - |
| 10 μg ControlMental Statusn=7 Participants | 0 | - |
| Speechn=7 Participants | 0 | - |
| Cranial Nerve Functionn=7 Participants | 0 | - |
| Cranial Nerve IIn=7 Participants | 0 | - |
| Sensory Functionn=7 Participants | 0 | - |
| Motor Functionn=7 Participants | 0 | - |
| Coordinationn=7 Participants | 0 | - |
| Gait and Stationn=7 Participants | 0 | - |
| Reflexesn=7 Participants | 0 | - |
| Deep Tendon Reflexesn=7 Participants | 0 | - |
| 30 μg ACC-001 TreatMental Statusn=13 Participants | 0 | - |
| Speechn=13 Participants | 0 | - |
| Cranial Nerve Functionn=13 Participants | 0 | - |
| Cranial Nerve IIn=13 Participants | 0 | - |
| Sensory Functionn=13 Participants | 0 | - |
| Motor Functionn=13 Participants | 0 | - |
| Coordinationn=13 Participants | 0 | - |
| Gait and Stationn=13 Participants | 1 | - |
| Reflexesn=13 Participants | 0 | - |
| Deep Tendon Reflexesn=13 Participants | 0 | - |
| 30 μg ControlMental Statusn=6 Participants | 1 | - |
| Speechn=6 Participants | 0 | - |
| Cranial Nerve Functionn=6 Participants | 0 | - |
| Cranial Nerve IIn=6 Participants | 0 | - |
| Sensory Functionn=6 Participants | 1 | - |
| Motor Functionn=6 Participants | 0 | - |
| Coordinationn=6 Participants | 0 | - |
| Gait and Stationn=6 Participants | 0 | - |
| Reflexesn=6 Participants | 0 | - |
| Deep Tendon Reflexesn=6 Participants | 0 | - |
Function / daily living
2 endpointsOther/protocol endpoint
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
Time frame:Baseline up to 24 Months
descriptive
Other_pre_specified/registry result
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
Time frame:Baseline up to 24 Months
descriptive
Neuroimaging
2 endpointsPrimary/protocol endpoint
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time frame:Baseline up to 24 months
event count, event
Primary/registry result
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time frame:Baseline up to 24 months
event count, event
Safety / tolerability / PK
2 endpointsPrimary/protocol endpoint
Number of Treatment Emergent Adverse Events (AEs) by Severity
Time frame:Baseline up to 24 months
event count, event
Primary/registry result
Number of Treatment Emergent Adverse Events (AEs) by Severity
Time frame:Baseline up to 24 months
event count, event
Posted result
| Group | Value (number), Events | Reported bounds |
|---|---|---|
| 3 μg ACC-001 TreatMildn=7 Participants | 14 | - |
| Moderaten=7 Participants | 2 | - |
| Severen=7 Participants | 0 | - |
| 3 μg ControlMildn=3 Participants | 7 | - |
| Moderaten=3 Participants | 0 | - |
| Severen=3 Participants | 0 | - |
| 10 μg ACC-001 TreatMildn=17 Participants | 97 | - |
| Moderaten=17 Participants | 14 | - |
| Severen=17 Participants | 6 | - |
| 10 μg ControlMildn=7 Participants | 38 | - |
| Moderaten=7 Participants | 2 | - |
| Severen=7 Participants | 0 | - |
| 30 μg ACC-001 TreatMildn=13 Participants | 28 | - |
| Moderaten=13 Participants | 3 | - |
| Severen=13 Participants | 2 | - |
| 30 μg ControlMildn=6 Participants | 17 | - |
| Moderaten=6 Participants | 4 | - |
| Severen=6 Participants | 0 | - |
Other (unclassified)
4 endpointsOther/protocol endpoint/low confidence
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Time frame:Baseline of preceding studies to month 24 of this study (Week 210)
descriptive
Other/protocol endpoint/low confidence
Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Time frame:Baseline of preceding studies to month 24 of this study (Week 210)
descriptive
Other_pre_specified/registry result/low confidence
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Time frame:Baseline of preceding studies to month 24 of this study (Week 210)
descriptive
Posted result
| Group | Value (geometric_mean), Units/mL | Reported bounds |
|---|---|---|
| 3 μg ACC-001+QS-21Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 60.3 | -38.1 - 95.5 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=7 Participants | 158.5 | -18.2 - 1381.1 |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 797.2 | -49.7 - 12776.7 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=7 Participants | 3202.0 | -168.8 - 60744.5 |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 494.2 | -49.1 - 4970.9 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 6174.8 | -1628.1 - 23419.5 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 4239.5 | -895.3 - 20075.3 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 1292.4 | -263.8 - 6331.1 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 6460.4 | -1521.1 - 27438.5 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 4928.0 | -1015.9 - 23904.5 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=7 Participants | 992.7 | -9.5 - 103353.0 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=7 Participants | 5444.2 | -634.1 - 46744.1 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 4584.4 | -2315.0 - 9078.7 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 2153.0 | -1108.4 - 4182.2 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 5374.9 | -2019.8 - 14303.3 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 7811.2 | -2656.5 - 22968.2 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 4668.7 | -1533.4 - 14214.4 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 2983.3 | -954.1 - 9328.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 16812.5 | -2685.3 - 105259.9 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 14763.7 | -3422.9 - 63679.1 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 1030.3 | -51.7 - 20540.2 |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=7 Participants | 6100.2 | -1730.5 - 21504.2 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=7 Participants | 2173.6 | -652.1 - 7244.7 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=7 Participants | 14800.8 | -4544.9 - 48199.8 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=7 Participants | 9185.4 | -3237.8 - 26058.4 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=7 Participants | 1682.2 | -38.5 - 73591.4 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 4506.7 | -59.6 - 340984.3 |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=7 Participants | 3312.9 | -918.1 - 11954.2 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=7 Participants | 5904.2 | -2760.4 - 12628.6 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=7 Participants | 7816.8 | -2323.1 - 26302.4 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 2353.6 | -164.1 - 33761.9 |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=7 Participants | 6813.3 | -1976.2 - 23490.5 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=7 Participants | 2998.5 | -853.4 - 10536.3 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=7 Participants | 6305.4 | -2243.7 - 17719.5 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=7 Participants | 8513.5 | -2074.4 - 34940.7 |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=7 Participants | 8602.3 | -4440.7 - 16664.0 |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 1074.9 | -0.1 - 8576667.2 |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 1944.9 | -81.6 - 46329.0 |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=7 Participants | 7062.8 | -5311.4 - 9391.7 |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 3653.9 | -0.0 - 8947070499.4 |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 3033.0 | -0.0 - 11447766146.8 |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 2074.7 | -78.6 - 54786.4 |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=7 Participants | 1291.4 | -0.0 - 404404006.6 |
| QS-21+(3 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=3 Participants | 50.0 | -NA - NA |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=3 Participants | 50.0 | -NA - NA |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 50.0 | -50.0 - 50.0 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 188.0 | -188.0 - 188.0 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 50.0 | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=3 Participants | 277.1 | -1.1 - 71502.3 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=3 Participants | 83.4 | -9.2 - 753.5 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=3 Participants | 872.2 | -1.7 - 459286.2 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=3 Participants | 1257.0 | -15.9 - 99324.4 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=3 Participants | 1548.4 | -1.3 - 1837780.1 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 50.0 | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=3 Participants | 323.7 | -4.0 - 25932.8 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=3 Participants | 4418.8 | -32.8 - 595262.2 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=3 Participants | 3706.5 | -28.6 - 480359.1 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 12571.0 | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=3 Participants | 979.6 | -447.2 - 2146.1 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=3 Participants | 1410.5 | -237.4 - 8381.7 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=3 Participants | 1833.3 | -101.1 - 33260.5 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=3 Participants | 1586.1 | -125.6 - 20025.2 |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=3 Participants | 739.7 | -32.9 - 16622.6 |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 2981.0 | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 2555.0 | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=3 Participants | 636.6 | -4.1 - 98882.9 |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 13166.0 | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 14096.0 | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 5502.0 | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=3 Participants | 1997.0 | -NA - NA |
| 10 μg ACC-001+QS-21Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 67.2 | -34.7 - 130.1 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=11 Participants | 73.5 | -36.6 - 147.2 |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 1346.8 | -289.6 - 6264.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=11 Participants | 2950.3 | -837.0 - 10399.3 |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 638.8 | -160.2 - 2547.6 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 5696.9 | -2541.3 - 12771.2 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 3471.2 | -1569.0 - 7680.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 1122.5 | -502.5 - 2507.3 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 6712.0 | -1862.9 - 24183.8 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 5417.0 | -1626.4 - 18042.7 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=11 Participants | 4480.4 | -34.4 - 583150.4 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=11 Participants | 4923.0 | -65.7 - 368774.1 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 2639.5 | -839.1 - 8302.7 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 1603.8 | -528.8 - 4864.7 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 7559.6 | -2614.6 - 21857.4 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 6204.2 | -1855.1 - 20749.6 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 3877.2 | -1217.4 - 12347.8 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 2488.3 | -836.1 - 7405.1 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 9783.0 | -3283.5 - 29148.1 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 7058.6 | -2484.5 - 20054.3 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=11 Participants | 4142.3 | -1719.9 - 9976.6 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=11 Participants | 2224.8 | -934.8 - 5295.0 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=11 Participants | 8306.6 | -4126.8 - 16719.9 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=11 Participants | 8081.4 | -4125.7 - 15829.8 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=11 Participants | 5926.3 | -2682.3 - 13093.5 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=11 Participants | 2251.0 | -704.2 - 7195.9 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=11 Participants | 11064.6 | -3340.9 - 36644.9 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=11 Participants | 10195.4 | -3243.3 - 32049.6 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=11 Participants | 7269.6 | -2546.0 - 20756.9 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=11 Participants | 4600.8 | -1798.3 - 11770.3 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=11 Participants | 6945.3 | -3865.8 - 12477.7 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=11 Participants | 10450.4 | -5734.0 - 19046.0 |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=11 Participants | 7551.2 | -3117.9 - 18288.2 |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=11 Participants | 3378.1 | -1687.3 - 6763.1 |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=11 Participants | NA | -NA - NA |
| 10 μg ACC-001+(10 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=6 Participants | NA | -NA - NA |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=6 Participants | NA | -NA - NA |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 108.7 | -41.8 - 282.7 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 94.9 | -43.4 - 207.3 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=6 Participants | 67.6 | -41.1 - 111.1 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=6 Participants | 688.8 | -118.8 - 3993.8 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=6 Participants | 551.4 | -81.2 - 3743.4 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=6 Participants | 831.0 | -59.8 - 11548.2 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=6 Participants | 435.9 | -45.5 - 4172.4 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=6 Participants | 2718.6 | -83.6 - 88360.8 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=6 Participants | 2572.6 | -101.9 - 64964.0 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=6 Participants | 3252.9 | -156.4 - 67657.2 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=6 Participants | 2532.8 | -97.0 - 66111.6 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=6 Participants | 4810.2 | -366.0 - 63211.9 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=6 Participants | 6398.1 | -417.4 - 98070.7 |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=6 Participants | 7027.0 | -485.8 - 101644.6 |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=6 Participants | 5682.1 | -345.0 - 93583.6 |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=6 Participants | NA | -NA - NA |
| QS-21+(10 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 110.7 | -12.2 - 1006.4 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 136.0 | -18.7 - 989.2 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 169.3 | -50.3 - 569.9 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=5 Participants | 105.9 | -40.1 - 279.5 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=5 Participants | 4818.1 | -1026.0 - 22626.7 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=5 Participants | 3726.2 | -1084.8 - 12799.5 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=5 Participants | 2335.3 | -715.0 - 7628.0 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=5 Participants | 1231.0 | -471.1 - 3216.5 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=5 Participants | 5233.2 | -2190.3 - 12503.5 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=5 Participants | 4614.4 | -1945.0 - 10947.8 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=5 Participants | 3163.7 | -1153.6 - 8676.4 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=5 Participants | 2880.8 | -1242.7 - 6678.3 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=5 Participants | 4080.8 | -0.0 - 11159747036.1 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=5 Participants | 6453.5 | -1202.3 - 34641.3 |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=5 Participants | 4351.5 | -1055.3 - 17944.0 |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=5 Participants | 5064.1 | -3850.7 - 6659.9 |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| PBS+(10 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=2 Participants | NA | -NA - NA |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=2 Participants | NA | -NA - NA |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 109.3 | -0.0 - 2265473.2 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=2 Participants | 1172.0 | -0.0 - 54658314329.3 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=2 Participants | 497.9 | -0.0 - 39348525251.6 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=2 Participants | 258.0 | -0.0 - 292460133977.7 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=2 Participants | 185.1 | -0.0 - 3083418082.5 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=2 Participants | 4957.3 | -0.0 - 89132252682601 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=2 Participants | 3490.4 | -0.0 - 129808983536252 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=2 Participants | 1338.7 | -0.0 - 2432477307830.6 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=2 Participants | 737.9 | -0.0 - 11966762355531 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=2 Participants | 3632.1 | -434.2 - 30382.4 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=2 Participants | 2362.8 | -0.4 - 13656178.6 |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=2 Participants | 1404.9 | -0.0 - 328577560.1 |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=2 Participants | 824.3 | -0.0 - 32731187354.9 |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| 30 μg ACC-001+QS-21Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 924.1 | -142.2 - 6003.5 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=8 Participants | 2543.1 | -969.3 - 6672.1 |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 386.9 | -87.7 - 1707.3 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 5266.4 | -1852.1 - 14975.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 5014.4 | -1788.3 - 14060.5 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 1765.8 | -638.5 - 4883.6 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 8383.3 | -4000.7 - 17566.9 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 7927.9 | -4408.1 - 14258.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=8 Participants | 7851.2 | -1669.4 - 36923.6 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=8 Participants | 18040.4 | -1536.5 - 211818.5 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 4899.8 | -1919.8 - 12505.5 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 2587.5 | -999.3 - 6699.7 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 10900.6 | -5915.4 - 20087.3 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 8052.1 | -4251.8 - 15249.1 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 3885.1 | -1951.3 - 7735.2 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 2272.0 | -1192.1 - 4330.1 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 14160.9 | -8518.5 - 23540.4 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 9998.6 | -5487.3 - 18218.7 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=8 Participants | 4291.7 | -2472.4 - 7449.7 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=8 Participants | 3167.0 | -1460.6 - 6867.2 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=8 Participants | 13370.6 | -6739.1 - 26527.7 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=8 Participants | 12209.4 | -6421.3 - 23215.2 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=8 Participants | 8613.4 | -4540.7 - 16339.2 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=8 Participants | 4197.4 | -2224.2 - 7921.3 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=8 Participants | 6043.9 | -1405.3 - 25993.5 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=8 Participants | 18653.9 | -20.0 - 17387177.2 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=8 Participants | 9664.4 | -6383.5 - 14631.5 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=8 Participants | 6706.3 | -164.9 - 272699.3 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=8 Participants | 7731.0 | -NA - NA |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=8 Participants | NA | -NA - NA |
| 30 μg ACC-001+(30 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=5 Participants | NA | -NA - NA |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=5 Participants | NA | -NA - NA |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 61.3 | -34.9 - 107.6 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 207.5 | -24.9 - 1726.5 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 166.0 | -20.3 - 1355.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 133.6 | -24.5 - 727.2 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 471.9 | -24.3 - 9181.4 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 408.1 | -19.8 - 8412.5 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=5 Participants | 287.4 | -21.2 - 3888.4 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=5 Participants | 522.7 | -30.5 - 8951.6 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 408.9 | -29.2 - 5733.6 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 205.0 | -27.1 - 1549.9 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 611.2 | -72.8 - 5131.5 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 458.0 | -65.9 - 3180.4 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 227.2 | -32.6 - 1582.8 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 231.0 | -34.2 - 1559.2 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 975.6 | -209.4 - 4546.5 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 768.3 | -126.4 - 4669.5 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=5 Participants | 391.5 | -56.2 - 2724.4 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=5 Participants | 464.0 | -40.3 - 5344.9 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=5 Participants | 3596.0 | -469.5 - 26042.1 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=5 Participants | 2504.2 | -464.4 - 13505.3 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=5 Participants | 1136.1 | -153.1 - 8429.8 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=5 Participants | 516.8 | -42.1 - 6345.2 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=5 Participants | 2189.8 | -39.4 - 121572.0 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=5 Participants | 1799.7 | -40.1 - 80796.0 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=5 Participants | 1022.4 | -41.4 - 25279.5 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=5 Participants | 706.6 | -41.7 - 11981.1 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=5 Participants | 1779.5 | -362.3 - 8741.0 |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=5 Participants | NA | -NA - NA |
| QS-21+(30 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 194.0 | -2.6 - 14517.7 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 50.0 | -50.0 - 50.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 196.4 | -30.3 - 1275.0 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 383.9 | -39.8 - 3700.8 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=4 Participants | 299.8 | -40.3 - 2229.5 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=4 Participants | 256.1 | -7.6 - 8678.4 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=4 Participants | 448.0 | -4.4 - 45743.6 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=4 Participants | 2670.5 | -0.0 - 463269086196.1 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=4 Participants | 2929.2 | -0.0 - 4137410775629.6 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=4 Participants | 1427.2 | -0.0 - 61098419244.5 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=4 Participants | 4629.0 | -NA - NA |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=4 Participants | NA | -NA - NA |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=4 Participants | NA | -NA - NA |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=4 Participants | NA | -NA - NA |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=4 Participants | NA | -NA - NA |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=4 Participants | NA | -NA - NA |
| PBS+(30 μg ACC-001+QS-21)Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=2 Participants | NA | -NA - NA |
| Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)n=2 Participants | NA | -NA - NA |
| Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 50.0 | -50.0 - 50.0 |
| Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 385.1 | -0.0 - 70941268874642 |
| Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 316.9 | -0.0 - 4897026295844.7 |
| Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)n=2 Participants | 285.8 | -0.0 - 1192613970596.0 |
| Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)n=2 Participants | 213.8 | -0.0 - 22254714647.2 |
| Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)n=2 Participants | 14665.8 | -0.0 - 2439205485421.2 |
| Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)n=2 Participants | 9454.1 | -0.0 - 2972501787380.5 |
| Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)n=2 Participants | 5735.6 | -0.0 - 50649360975.1 |
| Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)n=2 Participants | 3359.9 | -0.0 - 416391434.9 |
| Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)n=2 Participants | 14525.7 | -1101.4 - 191573.6 |
| Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)n=2 Participants | 6296.3 | -3108.1 - 12754.9 |
| Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)n=2 Participants | 4277.9 | -538.3 - 33999.7 |
| Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)n=2 Participants | 2643.6 | -1902.1 - 3674.2 |
| Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)n=2 Participants | 2518.0 | -NA - NA |
| Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
| Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)n=2 Participants | NA | -NA - NA |
Other_pre_specified/registry result/low confidence
Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Time frame:Baseline of preceding studies to month 24 of this study (Week 210)
descriptive
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.