Long Term Extension Study Evaluating Safety, Tolerability... | NCT00955409 | Trialant
NCT00955409
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 25, 2021Actual
Enrollment
160Actual
Phase
Phase 2
Conditions
Alzheimer Disease
Interventions
ACC-001(3µg) + QS21
ACC-001(10µg) + QS21
ACC-001(30µg) + QS21
Countries
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT00955409
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3134K1-2203
Secondary IDs
ID
Type
Description
Link
B2571007
Other Identifier
Alias Study Number
2009-010922-21
EudraCT Number
Brief Title
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Official Title
A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 5, 2009Actual
Primary Completion Date
Dec 17, 2013Actual
Completion Date
Dec 17, 2013Actual
First Submitted Date
Aug 4, 2009
First Submission Date that Met QC Criteria
Aug 7, 2009
First Posted Date
Aug 10, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 17, 2014
Results First Submitted that Met QC Criteria
Mar 1, 2021
Results First Posted Date
Mar 25, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 1, 2021
Last Update Posted Date
Mar 25, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
160Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ACC-001(3µg) + QS21
Experimental
ACC-001(3µg) + QS21
Biological: ACC-001(3µg) + QS21
ACC-001(10µg) + QS21
Experimental
ACC-001(10µg) + QS21
Biological: ACC-001(10µg) + QS21
ACC-001(30µg) + QS21
Experimental
ACC-001(30µg) + QS21
Biological: ACC-001(30µg) + QS21
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACC-001(3µg) + QS21
Biological
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(3µg) + QS21
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
24 months
Secondary Outcomes
Not provided
Other Outcomes
Measure
Description
Time Frame
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10
Exclusion Criteria:
Significant Neurological Disease other than Alzheimer's disease
Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
Clinically significant systemic illness
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
CMRR Bordeaux CHU Pellegrin
Bordeaux
33076
France
Hopital Roger Salengro
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
The Basic Results disclose pooled data from the extension studies 3134K1-2203-EU (B2571007) and 3134K1-2205-US (B2571008).
Recruitment Details
Planned duration was approximately 2 years (including 18 months of treatment + 6 months of follow-up). Participants who completed the lead-in 3134K1-200-EU (B2571004) study through Week 78 (Week 104 for Cohort 1 and 2) had the option to stay in the lead-in study or to roll-over into the extension protocol 3134K1-2203-EU (B2571007).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ACC 3 µg+QS-21 / ACC 3 µg+QS-21
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, 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.
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG002
ACC 10 µg+QS-21 / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG003
ACC 10 µg / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG004
QS-21 / ACC 10 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG005
PBS / ACC 10 µg+QS-21
Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG006
ACC 30 µg+QS-21 / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG007
ACC 30 µg / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG008
QS-21 / ACC 30 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG009
PBS / ACC 30 μg+QS-21
Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
FG00021 subjectsStarted=Randomized
FG0016 subjectsStarted=Randomized
FG00241 subjectsStarted=Randomized
FG00325 subjectsStarted=Randomized.
FG0045 subjectsStarted=Randomized
FG0059 subjectsStarted=Randomized
FG00627 subjectsStarted=Randomized
FG0076 subjectsStarted=Randomized
FG00816 subjectsStarted=Randomized
FG0094 subjectsStarted=Randomized
Treated
FG00021 subjects
FG0016 subjects
FG00241 subjects
FG00324 subjects
FG0045 subjects
FG0059 subjects
FG00627 subjects
FG0076 subjects
FG00816 subjects
FG0094 subjects
Completed Treatment
FG00012 subjects
FG0015 subjects
FG00215 subjects
FG00317 subjects
FG0043 subjects
FG0057 subjects
FG0064 subjects
FG0073 subjects
FG0082 subjects
FG0094 subjects
COMPLETED
FG00011 subjectsCompleted study
FG0015 subjectsCompleted study
FG00215 subjectsCompleted study
FG00317 subjectsCompleted study
FG0043 subjectsCompleted study
FG0056 subjectsCompleted study
FG0063 subjectsCompleted study
FG0072 subjectsCompleted study
FG0082 subjectsCompleted study
FG0093 subjectsCompleted study
NOT COMPLETED
FG00010 subjects
FG0011 subjects
FG00226 subjects
FG0038 subjects
FG0042 subjects
FG0053 subjects
FG00624 subjects
FG0074 subjects
FG00814 subjects
FG0091 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0025 subjects
FG0032 subjects
FG004
Caregiver Request
FG0002 subjects
FG0010 subjects
FG0026 subjects
FG0035 subjects
FG004
Investigator Request
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Discontinuation of Study by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Failed to Return
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event (AE)
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Reason not Specified
FG0002 subjects
FG0011 subjects
FG00213 subjects
FG0031 subjects
FG004
160 participants were randomized and included in analysis. Of these, 1 participant was not treated: at screening, the site felt that Mini-Mental State Examination (MMSE) score was artificially low due to language issue. Hence, study enrollment was approved. Later, participant discontinued from study, which was recorded as major protocol deviation.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ACC 3 µg+QS-21 / ACC 3 µg+QS-21
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG001
QS-21 / ACC 3 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG002
ACC 10 µg+QS-21 / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG003
ACC 10 µg / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG004
QS-21 / ACC 10 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG005
PBS / ACC 10 μg+QS-21
Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG006
ACC 30 µg+QS-21 / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG007
ACC 30 µg / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG008
QS-21 / ACC 30 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG009
PBS / ACC 30 μg+QS-21
Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG0016
BG00241
BG00325
BG0045
BG0059
BG00627
BG0076
BG00816
BG0094
BG010160
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00068.7± 6.94
BG00167.7± 9.52
BG00269.7± 9.29
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
BG002
MMSE Score
The Mini Mental Score Examination (MMSE) is a clinical instrument used for detecting cognitive impairment of the participants and assessing its severity. It is a brief, structured 11 item questionnaire that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall and language. The total score ranges from 0 to 30 and the following cut off was used for MMSE ranges >26 = no impairment; 21-26 = mild impairment; 10-20 = moderate impairment; <10 = severe impairment.
Mean
Standard Deviation
score
Title
Denominators
Categories
Title
Measurements
BG00016.7± 4.64
BG001
MMSE Ranges
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
MMSE score >26
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Other Pre-specified
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001
QS-21 / ACC 3 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002
ACC 10 µg+QS-21 / ACC 10 µg+QS-21
Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG003
ACC 10 µg / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG004
QS-21 / ACC 10 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG005
PBS / ACC 10 μg+QS-21
Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG006
ACC 30 μg+QS-21 / ACC 30 μg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG007
ACC 30 μg / ACC 30 μg+QS-21
Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG008
QS-21 / ACC 30 μg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG009
PBS / ACC 30 μg+QS-21
Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Other Pre-specified
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001
QS-21 / ACC 3 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002
ACC 10 µg+QS-21 / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG003
ACC 10 µg / ACC 10 µg+QS-21
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.
All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.
Posted
Number
percentage of participants
24 months
ID
Title
Description
OG000
ACC 3 µg+QS-21 / ACC 3 µg+QS-21
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001
QS-21 / ACC 3 µg+QS-21
Other Pre-specified
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, 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.
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.
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG001
QS-21 / ACC 3 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002
ACC 10 µg+QS-21 / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
Time Frame
Approximately 24 months, starting from Day 1, inclusive 18 months of dosing and 6 months of follow-up after the last dose.
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ACC 3 µg+QS-21 / ACC 3 µg+QS-21
Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
6
21
19
21
EG001
QS-21 / ACC 3 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
0
6
6
6
EG002
Active / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
16
65
55
65
EG003
Control / ACC 10µg+QS-21
Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
2
14
13
14
EG004
Active / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
4
33
23
33
EG005
Control / ACC 30 μg+QS-21
Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
4
20
17
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Syncope
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG0031 affected14 at risk
EG0042 affected33 at risk
EG0051 affected20 at risk
Cerebral haemosiderin deposition
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Dementia Alzheimers type
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Bradyarrhythmia
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Mitral valve prolapse
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Chest pain
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Device dislocation
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Pelvic mass
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Agitated depression
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Gallbladder cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Raynauds phenomenon
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected21 at risk
EG0010 affected6 at risk
EG00211 affected65 at risk
EG0032 affected14 at risk
EG0045 affected33 at risk
EG0056 affected20 at risk
Injection site erythema
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected21 at risk
EG0010 affected6 at risk
EG0025 affected65 at risk
EG003
Injection site swelling
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected6 at risk
EG0025 affected65 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected6 at risk
EG0024 affected65 at risk
EG003
Injection site bruising
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Injection site pruritus
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Injection site induration
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Injection site inflammation
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0022 affected65 at risk
EG003
Asthenia
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Induration
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Face oedema
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Inflammation
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Injection site hypersensitivity
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0014 affected6 at risk
EG0029 affected65 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected6 at risk
EG0026 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected6 at risk
EG0022 affected65 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0022 affected65 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0012 affected6 at risk
EG0020 affected65 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Infected bites
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Localised infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Lyme disease
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Wound infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0014 affected6 at risk
EG0025 affected65 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected6 at risk
EG0022 affected65 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0021 affected65 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Delusional perception
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected6 at risk
EG0025 affected65 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0026 affected65 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected6 at risk
EG0022 affected65 at risk
EG003
Syncope
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected6 at risk
EG0022 affected65 at risk
EG003
Dementia Alzheimers type
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0021 affected65 at risk
EG003
Tremor
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Hyperreflexia
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected21 at risk
EG0011 affected6 at risk
EG0023 affected65 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0022 affected65 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0004 affected21 at risk
EG0011 affected6 at risk
EG0027 affected65 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0003 affected21 at risk
EG0011 affected6 at risk
EG0022 affected65 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Periorbital contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0024 affected65 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0024 affected65 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0022 affected65 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0023 affected65 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0025 affected65 at risk
EG003
Haematoma
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected6 at risk
EG0023 affected65 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0023 affected65 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Weight decreased
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Bartonella test positive
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Urine output decreased
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Vitamin B1 decreased
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Glaucoma
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Heterophoria
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Retinal degeneration
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0021 affected65 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected6 at risk
EG0020 affected65 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected21 at risk
EG0010 affected6 at risk
EG0020 affected65 at risk
EG003
In 2013 the sponsor decided that ACC-001 would not be further developed in mild to moderate Alzheimer's disease, study drug administration was discontinued, and remaining participants were followed for safety for up to 6 months after last injection.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D000544
Alzheimer Disease
Ancestor Terms
ID
Term
D003704
Dementia
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D024801
Tauopathies
D019636
Neurodegenerative Diseases
D019965
Neurocognitive Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000603458
vanutide cridificar
C078785
saponin QA-21V1
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0052 subjects
FG0063 subjects
FG0071 subjects
FG0083 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
2 subjects
FG0050 subjects
FG00616 subjects
FG0070 subjects
FG0088 subjects
FG0091 subjects
72.4
± 9.12
BG00475.2± 8.23
BG00569.6± 7.94
BG00671.3± 9.20
BG00766.3± 9.42
BG00869.5± 6.95
BG00975.8± 7.89
BG01070.4± 8.61
21
BG00312
BG0043
BG0058
BG00616
BG0073
BG00814
BG0092
BG01094
Male
BG00010
BG0012
BG00220
BG00313
BG0042
BG0051
BG00611
BG0073
BG0082
BG0092
BG01066
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Black or African American
BG0000
BG0010
BG0021
BG0030
BG0041
BG0050
BG0061
BG0070
BG0080
BG0090
BG0103
Other
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
White
BG00020
BG0016
BG00240
BG00325
BG0044
BG0059
BG00626
BG0076
BG00816
BG0094
BG010156
18.3
± 5.61
BG00218.4± 5.92
BG00319.6± 5.45
BG00421.8± 4.21
BG00520.0± 6.14
BG00618.7± 4.98
BG00720.5± 4.76
BG00819.1± 4.84
BG00920.0± 4.69
BG01018.8± 5.29
5
BG0033
BG0041
BG0051
BG0061
BG0070
BG0081
BG0090
BG01012
MMSE score 21-26
BG0005
BG0012
BG0029
BG0037
BG0042
BG0053
BG0068
BG0073
BG0086
BG0093
BG01048
MMSE score 16-20
BG0005
BG0012
BG00212
BG00310
BG0042
BG0053
BG00611
BG0072
BG0086
BG0090
BG01053
MMSE score 10-15
BG00010
BG0012
BG00215
BG0035
BG0040
BG0052
BG0067
BG0071
BG0083
BG0091
BG01046
MMSE score <10
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG004
QS-21 / ACC 10 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG005
PBS / ACC 10 μg+QS-21
Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG006
ACC 30 μg+QS-21 / ACC 30 μg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG007
ACC 30 μg / ACC 30 μg+QS-21
Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG008
QS-21 / ACC 30 μg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG009
PBS / ACC 30 μg+QS-21
Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG002
Active / ACC 10 µg+QS-21
Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG003
Control / ACC 10 µg+QS-21
Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG004
Active / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG005
Control / ACC 30 μg+QS-21
Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
Units
Counts
Participants
OG00021
OG0016
OG00265
OG00314
OG00433
OG00520
Title
Denominators
Categories
Percentage of participants with AEs
Title
Measurements
OG000100.0
OG001100.0
OG00293.8
OG00392.9
OG00478.8
OG00590.0
Percentage of participants with SAEs
Title
Measurements
OG00028.6
OG0010
OG00224.6
OG003
OG003
ACC 10 µg / ACC 10 µg+QS-21
Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG004
QS-21 / ACC 10 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG005
PBS / ACC 10 μg+QS-21
Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG006
ACC 30 µg+QS-21 / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG007
ACC 30 µg / ACC 30 µg+QS-21
Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG008
QS-21 / ACC 30 µg+QS-21
Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
OG009
PBS / ACC 30 μg+QS-21
Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.