Clinical trial NCT02618941: Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
timeFrame: 12 months
measure: Number of patients who withdraw due to Adverse Events (AEs)
timeFrame: 12 months
measure: Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination
timeFrame: 12 months
Secondary outcomes:
measure: Immunological activity of AFFITOPE® vaccine PD01A
timeFrame: 12 months
Other outcomes:
measure: MDS-UPDRS Ia, II, III
timeFrame: 12 months
measure: PDQ39
timeFrame: 12 months
measure: PD NMS
timeFrame: 12 months
measure: Cognitive scales
timeFrame: 12 months
Locations:
city: Vienna
country: Austria
facility: Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Study officials:
affiliation: Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
name: Dieter Volc, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.