Overview

This trial is active, not recruiting.

Condition parkinson's disease
Treatment affitope® pd01a
Phase phase 1
Sponsor Affiris AG
Start date December 2015
End date December 2016
Trial size 26 participants
Trial identifier NCT02618941, 2015-004854-16, AFFiRiS 008AA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
one injection of 75µg AFFITOPE® PD01A/adjuvanted
affitope® pd01a
s.c. injection
(No Intervention)
Untreated control group

Primary Outcomes

Measure
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
time frame: 12 months
Number of patients who withdraw due to Adverse Events (AEs)
time frame: 12 months
Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination
time frame: 12 months

Secondary Outcomes

Measure
Immunological activity of AFFITOPE® vaccine PD01A
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 68 years old.

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

Additional Information

Official title 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
Principal investigator Dieter Volc, Prim. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Affiris AG.