Parkinson's Disease
Conditions
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.
Interventions
BIOLOGICALAFFITOPE® PD01A
s.c. injection
Sponsors
Affiris AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 68 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of any Serious Adverse Events (SAE) that are related to the study drug | 12 months | — |
| Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination | 12 months | — |
| Number of patients who withdraw due to Adverse Events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological activity of AFFITOPE® vaccine PD01A | 12 months | Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method) |
Other
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS Ia, II, III | 12 months | Change in motor/non-motor symptoms over time |
| Cognitive scales | 12 months | Change in non-motor PD symptoms over time |
| PD NMS | 12 months | Change in non-motor PD symptoms over time |
| PDQ39 | 12 months | Change in non-motor PD symptoms over time |
Countries
Austria
Outcome results
None listed