Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618941
• Other study ID #: AFFiRiS 008AA
• Secondary ID: 2015-004854-16
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2015
• Last updated: June 2, 2017
• Start date: February 2, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: June 2017
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Biological:
• AFFITOPE® PD01A
s.c. injection

Locations

Country	Name	City	State
Austria	Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MDS-UPDRS Ia, II, III	Change in motor/non-motor symptoms over time	12 months
Other	PDQ39	Change in non-motor PD symptoms over time	12 months
Other	PD NMS	Change in non-motor PD symptoms over time	12 months
Other	Cognitive scales	Change in non-motor PD symptoms over time	12 months
Primary	Occurrence of any Serious Adverse Events (SAE) that are related to the study drug		12 months
Primary	Number of patients who withdraw due to Adverse Events (AEs)	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
Primary	Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination		12 months
Secondary	Immunological activity of AFFITOPE® vaccine PD01A	Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method)	12 months