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

Parkinson's Disease Clinical Trial

— AFF008A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216188
• Other study ID #: AFFiRiS 008A
• Secondary ID: 2014-002489-54
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2014
• Last updated: August 14, 2015
• Start date: August 2014

Study information

• Verified date: August 2015
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 68 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Biological:
• AFFITOPE® PD01A
s.c. injection

Other:
• Control
Untreated control group

Locations

Country	Name	City	State
Austria	Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No