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Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

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ClinicalTrials.gov Identifier: NCT02618941
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : June 5, 2017
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 the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

In addition, up to 6 patients will be offered participation within an untreated control Group.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/adjuvanted
 Biological: AFFITOPE® PD01A
s.c. injection
No Intervention: Control
Untreated control group


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of any Serious Adverse Events (SAE) that are related to the study drug [ Time Frame: 12 months ]
  2. Number of patients who withdraw due to Adverse Events (AEs) [ Time Frame: 12 months ]
    The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated.

  3. Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Immunological activity of AFFITOPE® vaccine PD01A [ Time Frame: 12 months ]
    Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)


Other Outcome Measures:
  1. MDS-UPDRS Ia, II, III [ Time Frame: 12 months ]
    Change in motor/non-motor symptoms over time

  2. PDQ39 [ Time Frame: 12 months ]
    Change in non-motor PD symptoms over time

  3. PD NMS [ Time Frame: 12 months ]
    Change in non-motor PD symptoms over time

  4. Cognitive scales [ Time Frame: 12 months ]
    Change in non-motor PD symptoms over time


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, AFF008E and AFF008A
  • Written informed consent signed and dated by the patient and, preferentially, the caregiver
  • 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
  • All changes in conventional PD therapies must be available to the sponsor; in particular pharmacologic symptomatic PD medication allowing transformation to a Levodopa standard dose
  • A potential participant should be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except PD therapies, these will be recorded separately) 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 within 3 months before Visit 1 (except AFF008A)
  • 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: non-melanoma skin cancer, intraepithelial cervical neoplasia)
  • Active infectious disease (e.g., Hepatitis B, C)
  • Immunodeficiency
  • Significant systemic illness
  • Alcoholism or substance abuse
  • Prior and/or current treatment with experimental immunotherapeutics including IVIG with the exception of AFFITOPE® PD01A, with immune modulating 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): NCT02618941


Locations
Austria
Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Vienna, Austria, 1080
Sponsors and Collaborators
Affiris AG
Investigators
Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
More Information
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Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT02618941     History of Changes
Other Study ID Numbers: AFFiRiS 008AA
2015-004854-16 ( EudraCT Number )
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Neurodegenerative Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs