NCT02216188CompletedPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Affiris AG
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Tolerability
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 68 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Immunological(6 month)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)Parkinson's DiseaseNCT02618941Affiris AG26
Terminated
Phase 2
Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006Alzheimer´s DiseaseNCT02008513Affiris AG194
Completed
Not Applicable
Long-term Safety and Tolerability of AFFITOPE AD01Alzheimer's DiseaseNCT00711139Affiris AG22
Completed
Phase 1
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02Alzheimer's DiseaseNCT01093664Affiris AG20
Completed
Not Applicable
AD01 Follow up Extension VisitAlzheimer´s DiseaseNCT01225809Affiris AG17