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

NCT ID: NCT02618941

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2017-02-28

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 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AFFITOPE® PD01A + Adjuvant

one injection of 75µg AFFITOPE® PD01A/adjuvanted

Group Type: EXPERIMENTAL

AFFITOPE® PD01A

Intervention Type: BIOLOGICAL

s.c. injection

Control

Untreated control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AFFITOPE® PD01A

s.c. injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiris AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dieter Volc, Prim. Dr.

Role: PRINCIPAL_INVESTIGATOR

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Locations

Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt

Vienna, , Austria

Countries

Austria

References

McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.

Reference Type: DERIVED

PMID: 30741694 (View on PubMed)

Other Identifiers

2015-004854-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AFFiRiS 008AA

Identifier Type: -

Identifier Source: org_study_id