Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Biological: AFFITOPE® PD01A; Other: Control

• Registration Number: NCT02216188
• Lead Sponsor: Affiris AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: AFFITOPE® PD01A + Adjuvant	AFFITOPE® PD01A	one injection of 15µg AFFITOPE® PD01A/ adjuvanted
B: AFFITOPE® PD01A + Adjuvant	AFFITOPE® PD01A	one injection of 75µg AFFITOPE® PD01A/ adjuvanted
Control	Control	Untreated control group

Primary Outcome Measures

Name	Time	Method
Tolerability	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 Outcome Measures

Name	Time	Method
Immunological	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)

Trial Locations

Locations (1)

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna; 🇦🇹 Vienna, Austria