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

Affiris AG1 site in 1 country28 target enrollmentAugust 2014

ConditionsParkinson's Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Affiris AG
Enrollment: 28
Locations: 1
Primary Endpoint: Tolerability
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

August 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Affiris AG

Responsible Party

Sponsor

Eligibility 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

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)