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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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
OTHER: Control; Untreated control group	Other: Control; Untreated control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	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)	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunological	- 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)	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Activity	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)	6 month

Collaborators and Investigators

• Sponsor: Affiris AG
• Investigators: Principal Investigator: Dieter Volc, Prim, Dr., Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

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: August 1, 2014
• Primary Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (ESTIMATE): August 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

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 008A; 2014-002489-54 (EUDRACT_NUMBER)