Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008A)
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ClinicalTrials.gov Identifier: NCT02216188 |
Recruitment Status :
Completed
First Posted : August 13, 2014
Last Update Posted : August 17, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Biological: AFFITOPE® PD01A Other: Control | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: A: AFFITOPE® PD01A + Adjuvant
one injection of 15µg AFFITOPE® PD01A/ adjuvanted
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Biological: AFFITOPE® PD01A
s.c. injection |
Experimental: B: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/ adjuvanted
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Biological: AFFITOPE® PD01A
s.c. injection |
Control
Untreated control group
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Other: Control
Untreated control group |
- Tolerability [ Time Frame: 6 month ]
- 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)
- Immunological [ Time Frame: 6 month ]- 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)
- Clinical Activity [ Time Frame: 6 month ]
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 68 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216188
Austria | |
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna | |
Vienna, Austria |
Principal Investigator: | Dieter Volc, Prim, Dr. | Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna |
Responsible Party: | Affiris AG |
ClinicalTrials.gov Identifier: | NCT02216188 |
Other Study ID Numbers: |
AFFiRiS 008A 2014-002489-54 ( EudraCT Number ) |
First Posted: | August 13, 2014 Key Record Dates |
Last Update Posted: | August 17, 2015 |
Last Verified: | August 2015 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |