Alzheimer Disease
Conditions
Brief summary
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.
Interventions
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of mild to moderate Alzheimer's disease * Age 50-85 * Mini Mental State Examination (MMSE) 16-26 Other criteria apply
Exclusion criteria
* Significant Neurological Disease * Major psychiatric disorder * 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
United States
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 NCT00498602 study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol extension protocol NCT00960531.
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 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 Years STANDARD_DEVIATION 8.87 | 69.4 Years STANDARD_DEVIATION 7.82 | 68.8 Years STANDARD_DEVIATION 8.07 | 70.9 Years STANDARD_DEVIATION 9.59 | 71.9 Years STANDARD_DEVIATION 8.96 | 69.0 Years STANDARD_DEVIATION 9.27 | 69.3 Years STANDARD_DEVIATION 9.57 | 65.7 Years 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
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 SAEs | 17.5 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 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 SAEs | 41.7 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 |
| 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 |
| 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 |
| 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 |
| Phosphate Buffered Saline | Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) | Percentage of participants with AEs | 100 percentage of participants |
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
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 | 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 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 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 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 2 (N: 35, 60, 39, 35, 12, 43, 16) | 56.6 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 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 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 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 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 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 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 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 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 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 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 | 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 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 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 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 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 | 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 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 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 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 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 | 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 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 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 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 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 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 56 (N: 31, 52, 34, 32, 9, 34, 15) | 5906.1 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 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 30 (N: 33, 56, 36, 32, 10, 38, 16) | 4316.8 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 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 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 | 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 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 | 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 30 (N: 33, 56, 36, 32, 10, 38, 16) | 110.4 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 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 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 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 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 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 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 | 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 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 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 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 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 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 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 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 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 | 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 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 28 (N: 31, 51, 33, 29, 8, 36, 16) | 108.9 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 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 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 | 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 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 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 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 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 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 | 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 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 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 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 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 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 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 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 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 | 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 | 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 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 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 28 (N: 31, 51, 33, 29, 8, 36, 16) | 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 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 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 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 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 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 30 (N: 33, 56, 36, 32, 10, 38, 16) | 51.8 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 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 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 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 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 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 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 | 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 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 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 2 (N: 35, 60, 39, 35, 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 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 | 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 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 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 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 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 30 (N: 33, 56, 36, 32, 10, 38, 16) | 50.0 U/mL |
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 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 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 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 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 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 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 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 | 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 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 | 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 6 (N: 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 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 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 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 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 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 24 (N: 34, 58, 37, 33, 10, 40, 16) | 461.3 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 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 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 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 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 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 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 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 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 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 | 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 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 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 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 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 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 | Week 6 (N: 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 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 8 (N: 33, 57, 39, 33, 12, 41, 17) | 1903.8 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 91 (N: 15, 9, 3, 8, 2, 6, 2) | 1203.4 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 40 (N: 32, 54, 33, 33, 9, 37, 15) | 1855.9 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 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 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 6 (N: 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 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 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 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 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 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 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 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 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 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 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 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 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 | 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 104 (N: 15, 9, 4, 7, 1, 6, 2) | 620.3 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 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 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 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 | 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 6 (N: 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 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 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 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 78 (N: 31, 52, 32, 32, 8, 32, 14) | 107.5 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 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 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 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 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 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 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 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 | 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 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 2 (N: 35, 60, 39, 35, 12, 43, 16) | 46.5 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 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 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 | 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 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 6 (N: 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 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 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 | 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 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 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 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 56 (N: 31, 52, 34, 32, 9, 34, 15) | 438.5 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 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 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 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 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 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 16 (N: 33, 59, 38, 34, 12, 41, 16) | 271.8 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 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 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 6 (N: 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 14 (N: 33, 52, 39, 31, 11, 33, 14) | 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 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 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 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 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 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 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 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 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 | 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 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 10 (N: 34, 59, 40, 33, 12, 43, 17) | 36.3 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 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 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 | 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 24 (N: 34, 58, 37, 33, 10, 40, 16) | 30.9 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 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 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 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 | 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 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 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 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 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 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 | 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 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 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 2 (N: 35, 60, 39, 35, 12, 43, 16) | 26.5 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 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 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 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 6 (N: 36, 58, 37, 33, 12, 41, 16) | 25.0 U/mL |