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Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008A)

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ClinicalTrials.gov Identifier: NCT02216188
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Affiris AG

Study Description
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Brief Summary:

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

In addition, up to 8 patients will be offered participation within an untreated control group.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Biological: AFFITOPE® PD01A Other: Control Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008
Study Start Date : August 2014
Actual Primary Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A: AFFITOPE® PD01A + Adjuvant
one injection of 15µg AFFITOPE® PD01A/ adjuvanted
 Biological: AFFITOPE® PD01A
s.c. injection
Experimental: B: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/ adjuvanted
 Biological: AFFITOPE® PD01A
s.c. injection
Control
Untreated control group
 Other: Control
Untreated control group


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability [ Time Frame: 6 month ]
    • Occurrence of any Adverse Events (AE)
    • Occurrence of any Serious Adverse Events (SAE)
    • Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)


Secondary Outcome Measures :
  1. Immunological [ Time Frame: 6 month ]
    - Titer of antibodies specific for the immunizing peptide, KLH (keyhole limpet hemocyanin; carrier protein), aSynuclein (aSyn), bSyn, aggregated aSyn as assessed by ELlSA, FACS (or equivalent methods)


Other Outcome Measures:
  1. Clinical Activity [ Time Frame: 6 month ]
    • Change in motor symptoms (MDS-UPDRS III)
    • Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, PD NMS, cognition)
    • Change in biological and radiological markers (e.g. CSF alpha synuclein Levels in cerebrospinal fluid)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior participation in AFF008 and AFF008E
  • Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory)
  • In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these
  • Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
  • Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator

Exclusion Criteria:

  • Women of childbearing potential without birth control or pregnant women
  • Participation in another clinical trial (except AFF008E) within 3 months before Visit 0
  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
  • Autoimmune disease or allergy to components of the vaccine
  • History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
  • Active infectious disease
  • Immunodeficiency
  • Significant systemic illness or psychiatric illness
  • Alcoholism or substance abuse
  • Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation
  • Venous status rendering it impossible to place an i.v. access
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216188


Locations
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Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Austria
Sponsors and Collaborators
Affiris AG
Investigators
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Principal Investigator: Dieter Volc, Prim, Dr. Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT02216188    
Other Study ID Numbers: AFFiRiS 008A
2014-002489-54 ( EudraCT Number )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases