Long-term extensions of randomized vaccination trials of ACC-001 and QS-21 in mild to moderate Alzheimer’s disease
Open accessAbstract
OBJECTIVES: Long-term safety and tolerability of ACC-001 (vanutide cridificar), an antiamyloid- beta therapeutic vaccine, was evaluated in subjects with mild to moderate Alzheimer's disease. DESIGN: Phase 2a extension studies of randomized parent trials were conducted in the United States, European Union, and Japan. METHODS: Four immunizations of ACC-001 were administered at the same 3 dose levels (3, 10, and 30 μg) to subjects randomized in the parent studies; ACC-001 was administered with QS-21 adjuvant. Safety, tolerability, and immunogenicity were assessed during active treatment and 6-month follow-up. RESULTS: ACC-001 + QS-21 was well tolerated in the United States (N=110) and European Union (N=50), and Japan (N=53) extension studies; safety profile was similar to that observed in the parent studies, and no new safety signals were identified. Overall, injection site reactions were the most common adverse event in these studies. Anti-amyloid antibody titers were elicited in all groups, with the highest titers observed in subjects who received ACC-001 + QS-21 in both the parent and extension studies. CONCLUSIONS: Long-term exposure to ACC-001 + QS-21 was well tolerated in subjects with Alzheimer's disease, suggesting that side effects do not pose a principal limitation for anti-amyloid active immunotherapy. The highest anti-amyloid-beta IgG titers are elicited during long-term therapy with ACC-001 + QS-21 compared with other regimens.
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A phase 2 research using UB-311, a synthetic peptide utilized as an Aβ vaccine, is now underway in individuals with mild or moderate Alzheimer's disease; it produced a total response rate in phase 1, with swelling at the injection site and agitation as the most common side effects, and patients with mild Alzheimer's disease had a slower rate of cognitive decline.
“A phase 2 research using UB-311, a synthetic peptide utilized as an Aβ vaccine, is now underway in individuals who are experiencing mild or moderate episodes of AD. It produced a total response rate in AD patients during the phase 1 of clinical trial. Swelling at the injection site and agitation were the most common side effects. Patients with mild AD had a slower rate of cognitive decline (Hull”
From An update on the novel and approved drugs for Alzheimer disease (2022) · cites this paper as Hull et al., 2017
UB-311, a synthetic peptide used as Aβ vaccine, has been advanced into an ongoing phase 2 study in patients with mild and moderate Alzheimer disease; in phase 1, it induced a 100% responder rate, usual adverse effects were swelling at the injection site and agitation, and a slower cognitive decline rate was observed in patients with mild Alzheimer disease.
“UB-311, a synthetic peptide used as Aβ vaccine, has been advanced into an ongoing phase 2 study in patients with mild and moderate AD. In phase 1, it induced a 100% responder rate in patients with AD. The usual adverse effects were swelling in the injection site and agitation. A slower cognitive decline rate was observed in patients with mild AD.62”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [62]
Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials: CAD106, ABvac40, GV1001, ACC-001, UB-311, and Lu AF20513.
“Six active immunotherapy agents are currently studied in phase 1, 2, and 3 clinical trials:”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [62]
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- Authors
- Hull, M., Sadowsky, C., Arai, H., Leterme, G. L. P., Holstein, A., Booth, K., Peng, Y., Yoshiyama, T., Suzuki, H., Ketter, N., Liu, E., & Ryan, J. M.
- Affiliations
- Palm Beach Neurology (US)
- Juntendo University (JP)
- Pfizer (United States) (US)
- Pfizer (Japan) (JP)
- Janssen Research & Development (United States) (US)
- Venue
- Current Alzheimer Research
- Publisher
- Bentham Science Publishers Ltd.
- Published
- 2017-06-19
- Volume
- 14
- Issue
- 7
- Pages
- 696-708
- ISSN
- 1567-2050 (ISSN-L)
- PMC
- PMC5543567
- OpenAlex
- W2585057996
- Cited by
- 65
- References
- 20
- Citations by year
- 2026: 5 · 2025: 7 · 2024: 8 · 2023: 8 · 2022: 9 · 2021: 9 · 2020: 6 · 2019: 8 · 2018: 4 · 2017: 1
- FWCI
- 3.84
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Current Alzheimer Research (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- University of North Florida Digital Commons (University of North Florida) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- QS-21 adjuvant, Alzheimer's disease, long-term safety and tolerability, immunogenicity, injection site reactions, extension study
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Dose-Response Relationship, Immunologic, Europe, Female, Humans, International Cooperation, Japan, Longitudinal Studies, Male, Mental Status Schedule, Middle Aged, Recombinant Fusion Proteins, Saponins, United States, Vaccination, Amyloid beta-Peptides, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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