Evidence map›Paper›PMID 32882100›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2020

A Phase 1 Randomized Trial of Specific Active α-Synuclein Immunotherapies PD01A and PD03A in Multiple System Atrophy.

Wassilios G Meissner, Anne Pavy-Le Traon, Alexandra Foubert-Samier, Gergana Galabova, Monique Galitzky, Alexandra Kutzelnigg, Brice Laurens, Petra Lührs, Rossella Medori, Patrice Péran and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02270489 (A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy), which is not on this map. Cited by 57 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 3 pooled it
4.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02270489 phase1completednot on this map

A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Phase I Study Assessing the Safety and Exploring the Immunogenicity/Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early Multiple System Atrophy

TypeinterventionalSponsorAffiris AGRan2014 to 2017Enrolled30ConditionsMultiple System Atrophy, Neurodegenerative DiseasesArmsAFFITOPE® PD01A + Adjuvant, AFFITOPE® PD03A + Adjuvant, Adjuvant without active component
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 3 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Nocebo effect in multiple system atrophy: systematic review and meta-analysis of placebo-controlled clinical trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Pooled it
  3. Pooled it
  4. A Randomized First-in-Human Study With UB-312, a UBITh® α-Synuclein Peptide Vaccine.Movement disorders : official journal of the Movement Disorder Society · 2022
    Trial
  5. Trial
  6. Article
  7. Review
  8. Aiming at the Seed: α-Synuclein Immunotherapy in Multiple System Atrophy.Movement disorders : official journal of the Movement Disorder Society · 2026
    Article
  9. Article
  10. Multiple system atrophy: cure and care.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  11. The Progress of Active Immunotherapy for Parkinson's Disease.International journal of molecular sciences · 2026
    Review
  12. Organosulfur Compounds: Potential Therapeutics for Parkinson's Disease.CNS & neurological disorders drug targets · 2026
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 5 countries.

Wassilios G MeissnerService de Neurologie, CRMR Atrophie Multisystématisée, CHU Bordeaux, Bordeaux, France.ORCID 0000-0003-2172-7527
Anne Pavy-Le TraonService de Neurologie, CRMR Atrophie Multisystématisée, CHU Toulouse, Toulouse- INSERM U 1048 Institut des Maladies Métaboliques et Cardiovasculaires, Toulouse, France.
Alexandra Foubert-SamierService de Neurologie, CRMR Atrophie Multisystématisée, CHU Bordeaux, Bordeaux, France.
Gergana GalabovaAFFiRiS AG, Vienna, Austria.
Monique GalitzkyClinical Investigation Center CIC1436, French Reference Centre for MSA, University Hospital Toulouse, University Toulouse, France.
Alexandra KutzelniggAFFiRiS AG, Vienna, Austria.
Brice LaurensService de Neurologie, CRMR Atrophie Multisystématisée, CHU Bordeaux, Bordeaux, France.
Petra LührsAFFiRiS AG, Vienna, Austria.
Rossella MedoriAFFiRiS AG, Vienna, Austria.
Patrice PéranToNIC, Toulouse NeuroImaging Center, Université de Toulouse, Toulouse, France.ORCID 0000-0001-7200-0139
Umberto SabatiniInstitute of Neuroradiology, University Magna Graecia, Catanzaro, Italy.
Sylvain VergnetService de Neurologie, CRMR Atrophie Multisystématisée, CHU Bordeaux, Bordeaux, France.
Dieter VolcStudy Center PROSENEX Ambulatorium Betriebs GesmbH at Confraternität-Privatklinik, Vienna, Austria.
Werner PoeweDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Achim SchneebergerAFFiRiS AG, Vienna, Austria.
Günther StafflerAFFiRiS AG, Vienna, Austria.
Olivier RascolUniversité de Toulouse 3, CHU de Toulouse, INSERM, Centre de Reference AMS, Service de Neurologie et de Pharmacologie Clinique, Centre d'Investigation Clinique CIC1436, Réseau NS-Park/FCRIN et Centre of Excellence for Neurodegenerative Disorders (COEN) de Toulouse, Toulouse, France.
AFF009 Study Investigators
AFFiRiS (Austria) · ATInserm · FRUniversité Fédérale de Toulouse Midi-Pyrénées · FRCentre National de la Recherche Scientifique · FRInnsbruck Medical University · ATMagna Graecia University · ITMedigene (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disease with limited symptomatic treatment options. Aggregation of α-synuclein in oligodendrocytes is believed to be a central mechanism of the neurodegenerative process. PD01A and PD03A are 2 novel therapeutic vaccine candidates containing short peptides as antigenic moieties that are designed to induce a sustained antibody response, specifically targeting pathogenic assemblies of α-synuclein. The objectives of the current study were to evaluate primarily the safety and tolerability of PD01A and PD03A in patients with early MSA. Thirty patients (11 women) were randomized to receive 5 subcutaneous injections of either PD01A (n = 12), PD03A (n = 12), or placebo (n = 6) in this patient- and examiner-blinded, placebo-controlled, 52-week phase 1 clinical trial (ClinicalTrial.gov identifier: NCT02270489). Immunogenicity and clinical scores were assessed as secondary objectives. Twenty-nine patients reported a total of 595 treatment-emergent adverse events (mild or moderate, n = 555; severe, n = 40). Treatment-related adverse events included 190 injection-site reactions typically observed in vaccination trials with similar per-subject incidence in the treatment groups over time. Sustained IgG titers were observed in the PD01A-treated group, and 89% of treated patients developed a PD01-specific antibody response after receiving all injections. Induced antibodies displayed clear reactivity to the α-synuclein target epitope. Titers and antibody responder rate (58%) were lower in the PD03A-treated group. In conclusion, both PD01A and PD03A were safe and well tolerated. PD01A triggered a rapid and long-lasting antibody response that specifically targeted the α-synuclein epitope. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

Multiple System AtrophyParkinson Diseasealpha-SynucleinFemaleHumansMalePeptidesVaccinationalpha-SynucleinPeptidesactive immunizationMSAtreatmentα-synuclein

Identifiers

PMID32882100
PMCPMC7754431
OpenAlexW3083277842

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.