Safety, tolerability and immunogenicity of an active anti-Aβ40 vaccine (ABvac40) in patients with Alzheimer’s disease: a randomised, double-blind, placebo-controlled, phase I trial
Open accessAbstract
Immunotherapy targeting the amyloid-β (Aβ) peptide is a promising strategy for the treatment of Alzheimer’s disease (AD); however, none of the active or passive vaccines tested have been demonstrated to be effective to date. We have developed the first active vaccine against the C-terminal end of Aβ40, ABvac40, and assessed its safety and tolerability in a phase I clinical trial. A randomised, double-blind, placebo-controlled, parallel-group, phase I study of ABvac40 was conducted with patients aged 50–85 years with mild to moderate AD. Participants were entered into three separate groups according to time of study entry and were randomly allocated to receive ABvac40 or placebo (overall ratio 2:1). The first group received two half-doses of ABvac40 or placebo, whereas the second and third groups received two and three full doses, respectively. All treatments were administered subcutaneously at 4-week intervals. Patients, carers and investigators were blind to treatment allocation throughout the study. The primary objective was to assess the safety and tolerability of ABvac40 by registering all adverse events (AEs). All patients who received at least one dose of treatment were included in the safety analysis. The secondary objective was to evaluate the immunogenicity of ABvac40 by titration of specific anti-Aβ40 antibodies in plasma. Twenty-four patients were randomly allocated: 16 patients to the ABvac40 group and 8 patients to the placebo group. All randomised patients completed the study, therefore the intention-to-treat and safety populations were identical. Overall, 71 AEs affecting 18 patients were recorded: 11 (69%) in the ABvac40 group and 7 (88%) in the placebo group (p = 0.6214). Neither incident vasogenic oedema nor sulcal effusion (amyloid-related imaging abnormalities corresponding to vasogenic oedema and sulcal effusions) nor microhaemorrhages (amyloid-related imaging abnormalities corresponding to microhaemorrhages and hemosiderin deposits) were detected throughout the study period in the ABvac40-treated patients. Eleven of 12 (~92%) individuals receiving three injections of ABvac40 developed specific anti-Aβ40 antibodies. ABvac40 showed a favourable safety and tolerability profile while eliciting a consistent and specific immune response. An ongoing phase II clinical trial is needed to confirm these results and to explore the clinical efficacy of ABvac40. ClinicalTrials.gov, NCT03113812 . Retrospectively registered on 14 April 2017.
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The most common aspects of Alzheimer's disease involve accumulation of beta-amyloid plaques, tau proteins, and neuroinflammation; these are the main targets for candidate anti-Alzheimer vaccines.
“The most common aspects of AD involve the accumulation of beta-amyloid plaques, tau proteins, and neuroinflammation; these are the main targets for candidate anti-Alzheimer vaccines [48,49,50].”
From Multi-Target Mechanisms of Phytochemicals in Alzheimer’s Disease: Effects on Oxidative Stress, Neuroinflammation and Protein Aggregation (2022) · cites this paper as [50]
ABvac40 targets the C-terminus of Aβ peptides and is currently being evaluated in Phase 2 clinical studies.
“Another vaccine called ABvac40 targets the C-terminus of Aβ peptides and is also currently being evaluated in Phase 2 clinical studies.326”
From Amyloid β-based therapy for Alzheimer’s disease: Challenges, successes and future (2023) · cites this paper as [326]
GV1001 peptide (tertomotide) was previously studied as a vaccine against various cancers, whereas now it is evaluated in a phase 2 study for Alzheimer disease.
“GV1001 peptide (tertomotide) was previously studied as a vaccine against various cancers, whereas now it is evaluated in a phase 2 study for AD.60”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [60]
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 [60]
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- Authors
- Lacosta, A.-M., Pascual-Lucas, M., Pesini, P., Casabona, D., Pérez-Grijalba, V., Marcos-Campos, I., Sarasa, L., Canudas, J., Badi, H., Monleón, I., San-José, I., Munuera, J., Rodríguez-Gómez, O., Abdelnour, C., Lafuente, A., Buendía, M., Boada, M., Tárraga, L., Ruiz, A., & Sarasa, M.
- Affiliations
- Hospital Universitari Germans Trias i Pujol (ES)
- Fundació ACE (ES)
- Corresponding author
- Pesini, Pedro
- Venue
- Alzheimer's Research & Therapy
- Published
- 2018-01-29
- Volume
- 10
- Issue
- 1
- Pages
- 12-12
- ISSN
- 1758-9193 (ISSN-L)
- PMC
- PMC5789644
- OpenAlex
- W2789484532
- Cited by
- 111
- References
- 61
- Citations by year
- 2026: 9 · 2025: 20 · 2024: 14 · 2023: 19 · 2022: 16 · 2021: 14 · 2020: 9 · 2019: 6 · 2018: 3
- FWCI
- 5.50
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Alzheimer s Research & Therapy (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Araclon Biotech
- 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
- Alzheimer's disease, Aβ40, active immunotherapy, vaccine safety and tolerability, immunogenicity, anti-amyloid antibodies, amyloid-related imaging abnormalities, vasogenic edema, microhemorrhages, mild to moderate Alzheimer's disease, dose escalation, subcutaneous immunization
- MeSH terms
- Immunogenicity, Vaccine, Protein Domains, Aged, Aged, 80 and over, Alzheimer Disease, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Peptide Fragments, Severity of Illness Index, Amyloid beta-Peptides, Treatment Outcome, Alzheimer Vaccines
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