Alzheimer Disease
Conditions
Keywords
Alzheimer's Disease, active immunization
Brief summary
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Interventions
BIOLOGICALACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
BIOLOGICALACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
BIOLOGICALQS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
DRUGPlacebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
Sponsors
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26) * Brain MRI consistent with Alzheimer Disease * Concurent use of Chloniesterase inhibitor or memantine allowed if stable * Other inclusion criteria apply
Exclusion criteria
* Significant Neurological Disease other than Alzheimer's disease * Major psychiatric disorder * Contraindication to undergo brain MRI * Clinically significant systemic illness * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. | An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG. |
| GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM. |
| Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable) | Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | IgG subtypes were not assessed |
Countries
France, Germany, Spain
Participant flow
Recruitment details
Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).
Pre-assignment details
The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.
Participants by arm
| Arm | Count |
|---|---|
| ACC 3 µg+QS-21 Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 36 |
| ACC 10 µg+QS-21 Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 61 |
| ACC 30 µg+QS-21 Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 40 |
| ACC 10 µg Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 35 |
| ACC 30 µg Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 12 |
| QS-21 Alone Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 44 |
| Phosphate Buffered Saline Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months. | 17 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event (AE) related to Study Drug | 1 | 0 | 3 | 2 | 0 | 1 | 0 |
| Overall Study | AE not related to Study Drug | 1 | 3 | 0 | 0 | 2 | 2 | 1 |
| Overall Study | Caregiver Request | 2 | 2 | 2 | 0 | 1 | 2 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Investigator Request | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Other | 2 | 3 | 1 | 0 | 0 | 3 | 0 |
| Overall Study | Subject Request | 3 | 0 | 1 | 1 | 1 | 4 | 1 |
Baseline characteristics
| Characteristic | Total | Phosphate Buffered Saline | QS-21 Alone | ACC 30 µg | ACC 10 µg | ACC 30 µg+QS-21 | ACC 10 µg+QS-21 | ACC 3 µg+QS-21 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.1 year STANDARD_DEVIATION 8.87 | 69.4 year STANDARD_DEVIATION 7.82 | 68.8 year STANDARD_DEVIATION 8.07 | 70.9 year STANDARD_DEVIATION 9.59 | 71.9 year STANDARD_DEVIATION 8.96 | 69.0 year STANDARD_DEVIATION 9.27 | 69.3 year STANDARD_DEVIATION 9.57 | 65.7 year STANDARD_DEVIATION 7.75 |
| Mini-Mental State Examination (MMSE) Score | 21.4 score STANDARD_DEVIATION 3.13 | 21.2 score STANDARD_DEVIATION 3.17 | 21.7 score STANDARD_DEVIATION 3.11 | 21.8 score STANDARD_DEVIATION 3.6 | 21.6 score STANDARD_DEVIATION 3.16 | 21.0 score STANDARD_DEVIATION 2.92 | 21.4 score STANDARD_DEVIATION 3.38 | 21.4 score STANDARD_DEVIATION 2.96 |
| MMSE Stratum High (21 - 26) | 161 number of participants | 11 number of participants | 29 number of participants | 8 number of participants | 23 number of participants | 24 number of participants | 40 number of participants | 26 number of participants |
| MMSE Stratum Low (16 - 20) | 84 number of participants | 6 number of participants | 15 number of participants | 4 number of participants | 12 number of participants | 16 number of participants | 21 number of participants | 10 number of participants |
| Race/Ethnicity, Customized Asian | 1 number of participants | 0 number of participants | 0 number of participants | 1 number of participants | 0 number of participants | 0 number of participants | 0 number of participants | 0 number of participants |
| Race/Ethnicity, Customized Black or African American | 3 number of participants | 0 number of participants | 1 number of participants | 0 number of participants | 0 number of participants | 1 number of participants | 0 number of participants | 1 number of participants |
| Race/Ethnicity, Customized Other | 5 number of participants | 0 number of participants | 0 number of participants | 0 number of participants | 1 number of participants | 1 number of participants | 1 number of participants | 2 number of participants |
| Race/Ethnicity, Customized White | 236 number of participants | 17 number of participants | 43 number of participants | 11 number of participants | 34 number of participants | 38 number of participants | 60 number of participants | 33 number of participants |
| Sex: Female, Male Female | 139 Participants | 14 Participants | 31 Participants | 8 Participants | 19 Participants | 22 Participants | 29 Participants | 16 Participants |
| Sex: Female, Male Male | 106 Participants | 3 Participants | 13 Participants | 4 Participants | 16 Participants | 18 Participants | 32 Participants | 20 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 36 | 48 / 60 | 35 / 40 | 28 / 35 | 10 / 12 | 40 / 44 | 17 / 17 |
| serious Total, serious adverse events | 6 / 36 | 11 / 60 | 7 / 40 | 5 / 35 | 5 / 12 | 5 / 44 | 3 / 17 |
Outcome results
Primary
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Population: The safety population included all randomized participants with documented use of at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACC 3 µg+QS-21 | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 16.7 percentage of participants |
| ACC 3 µg+QS-21 | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 97.2 percentage of participants |
| ACC 10 µg+QS-21 | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 18.3 percentage of participants |
| ACC 10 µg+QS-21 | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 93.3 percentage of participants |
| ACC 30 µg+QS-21 | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 90.0 percentage of participants |
| ACC 30 µg+QS-21 | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 17.5 percentage of participants |
| ACC 10 µg | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 14.3 percentage of participants |
| ACC 10 µg | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 91.4 percentage of participants |
| ACC 30 µg | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 83.3 percentage of participants |
| ACC 30 µg | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 41.7 percentage of participants |
| QS-21 Alone | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 90.9 percentage of participants |
| QS-21 Alone | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 11.4 percentage of participants |
| Phosphate Buffered Saline | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 100 percentage of participants |
| Phosphate Buffered Saline | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with SAEs | 17.6 percentage of participants |
Secondary
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
IgG subtypes were not assessed
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Secondary
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Population: The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 1108.4 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 497.4 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 937.3 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 1824.6 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 1326.1 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 996.1 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 2011.2 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 1167.3 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 2028.9 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 547.8 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 907.5 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 2031.6 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 292.3 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 634.8 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 53.2 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 2635.7 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 1372.0 U/mL |
| ACC 3 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 56.6 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 2867.4 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 4299.6 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 2147.2 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 4316.8 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 2497.0 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 1867.5 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 885.2 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 69.0 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 77.1 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 1089.4 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 762.8 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 5744.6 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 2892.3 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 2212.7 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 3273.2 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 1364.4 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 1827.6 U/mL |
| ACC 10 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 5906.1 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 1098.2 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 543.0 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 3324.7 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 82.8 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 6677.3 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 243.3 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 1343.5 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 878.5 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 1231.3 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 4713.0 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 5407.7 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 3136.8 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 2292.9 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 2882.2 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 1262.3 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 7642.5 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 86.5 U/mL |
| ACC 30 µg+QS-21 | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 1338.1 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 76.1 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 76.8 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 51.7 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 89.6 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 50.0 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 66.3 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 160.6 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 73.4 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 166.3 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 91.7 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 80.7 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 159.2 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 108.9 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 142.7 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 77.0 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 98.9 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 97.2 U/mL |
| ACC 10 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 110.4 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 256.1 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 103.7 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 99.8 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 463.7 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 280.0 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 50.0 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 50.0 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 94.9 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 199.4 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 133.9 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 139.1 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 334.1 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 234.5 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 211.0 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 168.4 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 491.6 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 50.0 U/mL |
| ACC 30 µg | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 50.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 52.3 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 52.1 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 52.6 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 50.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 50.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 52.8 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 53.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 51.3 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 55.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 52.5 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 53.1 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 53.6 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 63.5 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 53.4 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 50.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 50.0 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 52.4 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 51.8 U/mL |
| QS-21 Alone | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 52.4 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54,34, 31, 9, 33, 15) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 50.0 U/mL |
| Phosphate Buffered Saline | Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 50.0 U/mL |
Secondary
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Population: The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 717.3 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 299.1 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 461.3 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 85.1 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 559.0 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 595.2 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 598.7 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 477.7 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 32.3 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 770.2 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 626.5 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 351.3 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 727.3 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 669.0 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 758.9 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 391.2 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 82.3 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 368.2 U/mL |
| ACC 3 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 457.6 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 1204.4 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 3098.3 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 1697.7 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 2721.0 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 1049.6 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 1203.4 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 1422.0 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 1561.8 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 1696.1 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 38.2 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 1351.6 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 1529.1 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 127.7 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 2259.4 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 123.4 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 1915.3 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 1283.8 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 1862.5 U/mL |
| ACC 10 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 1903.8 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 4147.2 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 2769.5 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 2681.8 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 1736.6 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 5271.3 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 276.6 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 679.2 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 3593.2 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 2598.1 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 1217.7 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 34.2 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 1637.2 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 5666.4 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 2479.5 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 1246.4 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 620.3 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 2672.4 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 254.5 U/mL |
| ACC 30 µg+QS-21 | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 1855.9 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 98.9 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 72.3 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 103.9 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 109.8 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 176.7 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 32.9 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 46.5 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 48.2 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 70.8 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 69.9 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 80.8 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 93.4 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 90.8 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 105.5 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 128.4 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 84.7 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 121.1 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 114.3 U/mL |
| ACC 10 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 107.5 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 25.0 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 144.1 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 76.9 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 311.9 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 343.3 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 436.9 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 346.0 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 294.6 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 296.2 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 40.3 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 166.4 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 157.1 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 342.1 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 290.7 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 92.0 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 25.0 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 590.9 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 271.8 U/mL |
| ACC 30 µg | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 438.5 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 31.0 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 34.2 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 34.5 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 31.1 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 30.9 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 33.2 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 31.3 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 31.5 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 37.8 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 32.2 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 30.8 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 34.6 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 36.2 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 25.0 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 34.3 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 28.3 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 36.1 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 36.6 U/mL |
| QS-21 Alone | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 31.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 6 (M: 36, 58, 37, 33, 12, 41, 16) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 29.5 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 28.9 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 27.3 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 27.3 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 26.3 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 25.0 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 26.6 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 27.2 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 27.8 U/mL |
| Phosphate Buffered Saline | GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 | Week 2 (N: 35, 60, 39, 35, 12,43, 16) | 26.5 U/mL |