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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Biological: AFFITOPE® PD01A

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1080
    • Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who withdraw due to Adverse Events (AEs)	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.	12 months
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug		12 months
Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunological activity of AFFITOPE® vaccine PD01A	Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MDS-UPDRS Ia, II, III	Change in motor/non-motor symptoms over time	12 months
PDQ39	Change in non-motor PD symptoms over time	12 months
PD NMS	Change in non-motor PD symptoms over time	12 months
Cognitive scales	Change in non-motor PD symptoms over time	12 months

Collaborators and Investigators

• Sponsor: Affiris AG
• Investigators: Principal Investigator: Dieter Volc, Prim. Dr., Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Publications and helpful links

General Publications

• McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: AFFiRiS 008AA; 2015-004854-16 (EudraCT Number)