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Trial record 1 of 6 for:    Affitope PD01A
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Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 25, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date June 5, 2017
Actual Study Start Date  ICMJE February 2, 2016
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • Occurrence of any Serious Adverse Events (SAE) that are related to the study drug [ Time Frame: 12 months ]
  • 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.
  • Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2015)
  • MDS-UPDRS Ia, II, III [ Time Frame: 12 months ]
    Change in motor/non-motor symptoms over time
  • PDQ39 [ Time Frame: 12 months ]
    Change in non-motor PD symptoms over time
  • PD NMS [ Time Frame: 12 months ]
    Change in non-motor PD symptoms over time
  • Cognitive scales [ Time Frame: 12 months ]
    Change in non-motor PD symptoms over time
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Biological: AFFITOPE® PD01A
s.c. injection
Study Arms  ICMJE
  • Experimental: AFFITOPE® PD01A + Adjuvant
    one injection of 75µg AFFITOPE® PD01A/adjuvanted
    Intervention: Biological: AFFITOPE® PD01A
  • No Intervention: Control
    Untreated control group
Publications * McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2015)
28
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618941
Other Study ID Numbers  ICMJE AFFiRiS 008AA
2015-004854-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Affiris AG
Study Sponsor  ICMJE Affiris AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
PRS Account Affiris AG
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP