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

• ClinicalTrials.gov Identifier: NCT02618941
• Recruitment Status: Completed
• First Posted: December 2, 2015
• Last Update Posted: June 5, 2017
• Sponsor: Affiris AG
• Information provided by (Responsible Party): Affiris AG

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004.

• Responsible Party: Affiris AG
• ClinicalTrials.gov Identifier: NCT02618941
• Other Study ID Numbers: AFFiRiS 008AA; 2015-004854-16 ( EudraCT Number )
• First Posted: December 2, 2015
• 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