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Completed

NCT Number: NCT02618941

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

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.

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Key information

Age range

40 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Vienna, 1080, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFFITOPE® PD01A

Biological

s.c. injection

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2015
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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