Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ACC-001
ACC-001+ QS-21 · 5 trials · 2 indications
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.
Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
| Arm | Type | Description |
|---|---|---|
| ACC-001(3µg) + QS21 | EXPERIMENTAL | ACC-001(3µg) + QS21 |
| ACC-001(10µg) + QS21 | EXPERIMENTAL | ACC-001(10µg) + QS21 |
| ACC-001(30µg) + QS21 | EXPERIMENTAL | ACC-001(30µg) + QS21 |
| ACC-001 + QS-21 | EXPERIMENTAL | Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 |
| QS-21 | PLACEBO_COMPARATOR | Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12 |
| ACC-001+QS-21 | EXPERIMENTAL | Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
| ACC-001 | EXPERIMENTAL | Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
| PBS | PLACEBO_COMPARATOR | Placebo, IM injection, Day 1, month 3, 6, 9, 12 |
| 1 | EXPERIMENTAL | ACC-001 |
| 2 | OTHER | QS-21 |
| 3 | OTHER | Diluent: Phosphate Buffered Saline |
| 4 | EXPERIMENTAL | ACC-001 |
| Name | Type | Description |
|---|---|---|
| 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(10µg) + QS21 | BIOLOGICAL | Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18 |
| ACC-001(30µg) + QS21 | BIOLOGICAL | Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18 |
| ACC-001 | BIOLOGICAL | IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 |
| QS-21 | OTHER | IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12 |
| PBS | OTHER | IM injection, Day 1, month 3, 6, 9, 12 |
| ACC-001 + QS-21 | BIOLOGICAL | IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52 |
| Diluent: Phosphate Buffered Saline | OTHER | IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52 |
| Placebo: Phosphate buffered saline | DRUG | Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12 |
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 Neu...
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ACC-001+ QS-21 is an investigational monoclonal antibody-based vaccine being studied for Alzheimer disease. It combines ACC-001 with the QS-21 adjuvant and was developed by Pfizer, Inc. (PFE). The program reached Phase 2 clinical development, and all of its recorded trials are now completed.
ACC-001+ QS-21 was studied for the treatment of mild to moderate Alzheimer disease. Its Phase 2 trials enrolled adults aged 50 years and older with that diagnosis. The program is investigational and is not an approved therapy for Alzheimer disease.
Pfizer, Inc. (ticker PFE) is the developer of ACC-001+ QS-21. The company sponsored the Phase 2 clinical program evaluating the vaccine candidate in patients with mild to moderate Alzheimer disease across sites in the United States, Japan, and Europe.
ACC-001+ QS-21 reached Phase 2 clinical development. Five trials were conducted in total, all of which are completed, with no active trials ongoing. The candidate remains investigational and has not been approved for marketing.
ACC-001+ QS-21 was evaluated in five completed Phase 2 trials, including NCT00498602 and NCT00955409, each enrolling 160 patients, plus NCT00752232 and NCT00959192 in Japan. The studies were randomized, double-blind, and controlled, with total enrollment of 478 participants.
ACC-001+ QS-21 is the combination of ACC-001 with the QS-21 adjuvant, and it is also written as ACC-001 + QS-21, ACC-001+ QS21, or ACC-001(3µg) + QS21. Searches for ACC-001 refer to the same Pfizer Alzheimer disease vaccine program.