- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02618941
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1080
- Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AFFITOPE® PD01A + Adjuvant
one injection of 75µg AFFITOPE® PD01A/adjuvanted
|
s.c. injection
|
No Intervention: Control
Untreated control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who withdraw due to Adverse Events (AEs)
Time Frame: 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.
|
12 months
|
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
Time Frame: 12 months
|
12 months
|
|
Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunological activity of AFFITOPE® vaccine PD01A
Time Frame: 12 months
|
Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MDS-UPDRS Ia, II, III
Time Frame: 12 months
|
Change in motor/non-motor symptoms over time
|
12 months
|
PDQ39
Time Frame: 12 months
|
Change in non-motor PD symptoms over time
|
12 months
|
PD NMS
Time Frame: 12 months
|
Change in non-motor PD symptoms over time
|
12 months
|
Cognitive scales
Time Frame: 12 months
|
Change in non-motor PD symptoms over time
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dieter Volc, Prim. Dr., Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFFiRiS 008AA
- 2015-004854-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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