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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT02216188
• Date of registration: 12/08/2014
• Prospective Registration: No
• Primary sponsor: Affiris AG
• Public title: Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity AFF008A
• Scientific 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
• Date of first enrolment: August 2014
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02216188
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Austria

Contacts

• Name: Dieter Volc, Prim, Dr.
• Affiliation: Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 68 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: Control

Biological: AFFITOPE® PD01A

Primary Outcome(s)

Tolerability [Time Frame: 6 month]

Secondary Outcome(s)

Immunological [Time Frame: 6 month]

Secondary ID(s)

AFFiRiS 008A

2014-002489-54

Source(s) of Monetary Support

Please refer to primary and secondary sponsors